Trial Outcomes & Findings for Comprehensive Adaptive Multisite Prevention of University Student Suicide (NCT NCT04707066)
NCT ID: NCT04707066
Last Updated: 2026-08-19
Results Overview
Change in score of CAMS Scale for Suicidal Ideation (SSI). This is a 19 question measure, each rated from 0-2. Total score is from 0-38, with a higher score indicating greater suicidality concern.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
253 participants
Primary outcome timeframe
Baseline to the end of Phase 1 treatment (up to 6 weeks)
Results posted on
2026-08-19
Participant Flow
For each Arm/Group, Phase 1 refers to Baseline through Week 6 while Phase 2 refers to the end of Phase 1 up to Week 14.
Participant milestones
| Measure |
Phase 1 CAMS Responder, Ongoing Maintenance/Monitoring
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Maintenance/Monitoring - Phase 2
(Note: Counselors not included here as these measures pertained only to student participants.)
|
Phase 1 CAMS Insufficient Responder, Phase 2 CAMS
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
(Note: Counselors not included here as these measures pertained only to student participants.)
|
Phase 1 CAMS Insufficient Responder, Phase 2 DBT
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
(Note: Counselors not included here as these measures pertained only to student participants.)
|
Phase 1 TAU Responder, Ongoing Maintenance/Monitoring
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
Treatment As Usual (TAU) - Phase 1
Maintenance/Monitoring - Phase 2
(Note: Counselors not included here as these measures pertained only to student participants.)
|
Phase 1 TAU Insufficient Responder, Phase 2 CAMS
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
Treatment As Usual (TAU) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
(Note: Counselors not included here as these measures pertained only to student participants.)
|
Phase 1 TAU Insufficient Responder, Phase 2 DBT
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
Treatment As Usual (TAU) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
(Note: Counselors not included here as these measures pertained only to student participants.)
|
College Counseling Centers (CCC) Counselors
All Counselors who were consented to this protocol, though none will have completed outcome measures as these do not pertain to this arm.
|
|---|---|---|---|---|---|---|---|
|
Phase 1: Baseline to Week 6
STARTED
|
47
|
30
|
36
|
40
|
36
|
38
|
26
|
|
Phase 1: Baseline to Week 6
COMPLETED
|
40
|
15
|
20
|
32
|
26
|
17
|
23
|
|
Phase 1: Baseline to Week 6
NOT COMPLETED
|
7
|
15
|
16
|
8
|
10
|
21
|
3
|
|
Phase 2: Week 6 to Week 14
STARTED
|
47
|
30
|
36
|
40
|
36
|
38
|
26
|
|
Phase 2: Week 6 to Week 14
COMPLETED
|
40
|
15
|
20
|
32
|
26
|
17
|
23
|
|
Phase 2: Week 6 to Week 14
NOT COMPLETED
|
7
|
15
|
16
|
8
|
10
|
21
|
3
|
Reasons for withdrawal
| Measure |
Phase 1 CAMS Responder, Ongoing Maintenance/Monitoring
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Maintenance/Monitoring - Phase 2
(Note: Counselors not included here as these measures pertained only to student participants.)
|
Phase 1 CAMS Insufficient Responder, Phase 2 CAMS
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
(Note: Counselors not included here as these measures pertained only to student participants.)
|
Phase 1 CAMS Insufficient Responder, Phase 2 DBT
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
(Note: Counselors not included here as these measures pertained only to student participants.)
|
Phase 1 TAU Responder, Ongoing Maintenance/Monitoring
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
Treatment As Usual (TAU) - Phase 1
Maintenance/Monitoring - Phase 2
(Note: Counselors not included here as these measures pertained only to student participants.)
|
Phase 1 TAU Insufficient Responder, Phase 2 CAMS
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
Treatment As Usual (TAU) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
(Note: Counselors not included here as these measures pertained only to student participants.)
|
Phase 1 TAU Insufficient Responder, Phase 2 DBT
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
Treatment As Usual (TAU) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
(Note: Counselors not included here as these measures pertained only to student participants.)
|
College Counseling Centers (CCC) Counselors
All Counselors who were consented to this protocol, though none will have completed outcome measures as these do not pertain to this arm.
|
|---|---|---|---|---|---|---|---|
|
Phase 1: Baseline to Week 6
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Phase 1: Baseline to Week 6
Lost to Follow-up
|
6
|
3
|
3
|
7
|
5
|
6
|
0
|
|
Phase 1: Baseline to Week 6
Physician Decision
|
0
|
2
|
0
|
0
|
0
|
3
|
0
|
|
Phase 1: Baseline to Week 6
Protocol Violation
|
0
|
1
|
3
|
0
|
2
|
6
|
0
|
|
Phase 1: Baseline to Week 6
Withdrawal by Subject
|
0
|
3
|
6
|
1
|
1
|
1
|
0
|
|
Phase 1: Baseline to Week 6
Other
|
1
|
6
|
4
|
0
|
2
|
4
|
0
|
|
Phase 1: Baseline to Week 6
Exited Practicum Program
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Comprehensive Adaptive Multisite Prevention of University Student Suicide
Baseline characteristics by cohort
| Measure |
Phase 1 CAMS Responder, Ongoing Maintenance/Monitoring
n=47 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 CAMS
n=30 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 DBT
n=36 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
Phase 1 TAU Responder, Ongoing Maintenance/Monitoring
n=40 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
Treatment As Usual (TAU) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 CAMS
n=36 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
Treatment As Usual (TAU) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 DBT
n=38 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
Treatment As Usual (TAU) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
College Counseling Center (CCC) Counselors
All Counselors who were consented to this protocol, though none will have completed outcome measures as these do not pertain to this arm.
|
Total
n=227 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Sex/Gender, Customized
Sex/Gender · Male
|
15 Participants
n=298 Participants
|
14 Participants
n=102 Participants
|
14 Participants
n=400 Participants
|
16 Participants
n=30 Participants
|
10 Participants
n=1389 Participants
|
12 Participants
n=44 Participants
|
—
|
81 Participants
n=97 Participants
|
|
Age, Continuous
|
20.43 years
STANDARD_DEVIATION 2.33 • n=298 Participants
|
20.13 years
STANDARD_DEVIATION 1.53 • n=102 Participants
|
19.86 years
STANDARD_DEVIATION 1.94 • n=400 Participants
|
19.95 years
STANDARD_DEVIATION 2.04 • n=30 Participants
|
20.25 years
STANDARD_DEVIATION 2.05 • n=1389 Participants
|
19.63 years
STANDARD_DEVIATION 1.81 • n=44 Participants
|
—
|
20.04 years
STANDARD_DEVIATION 1.95 • n=97 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Female
|
32 Participants
n=298 Participants
|
16 Participants
n=102 Participants
|
20 Participants
n=400 Participants
|
24 Participants
n=30 Participants
|
26 Participants
n=1389 Participants
|
26 Participants
n=44 Participants
|
—
|
144 Participants
n=97 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Unknown or Not Reported
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
2 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
—
|
2 Participants
n=97 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=298 Participants
|
10 Participants
n=102 Participants
|
13 Participants
n=400 Participants
|
6 Participants
n=30 Participants
|
8 Participants
n=1389 Participants
|
8 Participants
n=44 Participants
|
—
|
59 Participants
n=97 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=298 Participants
|
19 Participants
n=102 Participants
|
23 Participants
n=400 Participants
|
33 Participants
n=30 Participants
|
28 Participants
n=1389 Participants
|
30 Participants
n=44 Participants
|
—
|
166 Participants
n=97 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=298 Participants
|
1 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
—
|
2 Participants
n=97 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=298 Participants
|
1 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
—
|
1 Participants
n=97 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=298 Participants
|
6 Participants
n=102 Participants
|
7 Participants
n=400 Participants
|
5 Participants
n=30 Participants
|
5 Participants
n=1389 Participants
|
5 Participants
n=44 Participants
|
—
|
32 Participants
n=97 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
1 Participants
n=44 Participants
|
—
|
1 Participants
n=97 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=298 Participants
|
2 Participants
n=102 Participants
|
1 Participants
n=400 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=1389 Participants
|
3 Participants
n=44 Participants
|
—
|
19 Participants
n=97 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=298 Participants
|
16 Participants
n=102 Participants
|
16 Participants
n=400 Participants
|
24 Participants
n=30 Participants
|
18 Participants
n=1389 Participants
|
24 Participants
n=44 Participants
|
—
|
126 Participants
n=97 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=298 Participants
|
2 Participants
n=102 Participants
|
8 Participants
n=400 Participants
|
6 Participants
n=30 Participants
|
7 Participants
n=1389 Participants
|
2 Participants
n=44 Participants
|
—
|
31 Participants
n=97 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=298 Participants
|
3 Participants
n=102 Participants
|
4 Participants
n=400 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=1389 Participants
|
3 Participants
n=44 Participants
|
—
|
17 Participants
n=97 Participants
|
|
Region of Enrollment
United States
|
47 Participants
n=298 Participants
|
30 Participants
n=102 Participants
|
36 Participants
n=400 Participants
|
40 Participants
n=30 Participants
|
36 Participants
n=1389 Participants
|
38 Participants
n=44 Participants
|
—
|
227 Participants
n=97 Participants
|
PRIMARY outcome
Timeframe: Baseline to the end of Phase 1 treatment (up to 6 weeks)Population: Participants with data collected at both baseline and end of Phase 1 (week 6). Data not collected on CCC Counselors.
Change in score of CAMS Scale for Suicidal Ideation (SSI). This is a 19 question measure, each rated from 0-2. Total score is from 0-38, with a higher score indicating greater suicidality concern.
Outcome measures
| Measure |
College Counseling Centers (CCC) Counselors
All Counselors who were consented to this protocol, though none will have completed outcome measures as these do not pertain to this arm.
|
Phase 1 CAMS Responder, Ongoing Maintenance/Monitoring
n=44 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 CAMS
n=22 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 DBT
n=29 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
Phase 1 TAU Responder, Ongoing Maintenance/Monitoring
n=38 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
Treatment As Usual (TAU) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 CAMS
n=35 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
Treatment As Usual (TAU) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 DBT
n=31 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
Treatment As Usual (TAU) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
|---|---|---|---|---|---|---|---|
|
Suicide Ideation - Phase 1
|
—
|
-7.59 score on a scale
Standard Deviation 7.44
|
-3.05 score on a scale
Standard Deviation 5.79
|
-3.72 score on a scale
Standard Deviation 6.86
|
-8.21 score on a scale
Standard Deviation 8.55
|
-2.89 score on a scale
Standard Deviation 6.52
|
-5.32 score on a scale
Standard Deviation 8.10
|
PRIMARY outcome
Timeframe: Baseline to the end of Stage 2 treatment (up to 14 weeks)Population: Participants with data collected at both baseline and end of Phase 2 (week 14). Data not collected on CCC Counselors.
Change in score of CAMS Scale for Suicidal Ideation (SSI). This is a 19 question measure, each rated from 0-2. Total score is from 0-38, with a higher score indicating greater suicidality concern.
Outcome measures
| Measure |
College Counseling Centers (CCC) Counselors
All Counselors who were consented to this protocol, though none will have completed outcome measures as these do not pertain to this arm.
|
Phase 1 CAMS Responder, Ongoing Maintenance/Monitoring
n=41 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 CAMS
n=21 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 DBT
n=26 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
Phase 1 TAU Responder, Ongoing Maintenance/Monitoring
n=33 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
Treatment As Usual (TAU) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 CAMS
n=32 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
Treatment As Usual (TAU) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 DBT
n=27 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
Treatment As Usual (TAU) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
|---|---|---|---|---|---|---|---|
|
Suicide Ideation - Phase 2
|
—
|
-8.44 score on a scale
Standard Deviation 6.43
|
-8.19 score on a scale
Standard Deviation 8.20
|
-5.19 score on a scale
Standard Deviation 7.44
|
-10.27 score on a scale
Standard Deviation 6.16
|
-9.34 score on a scale
Standard Deviation 7.61
|
-8.44 score on a scale
Standard Deviation 6.81
|
PRIMARY outcome
Timeframe: Baseline to the end of follow-up (up to 26 weeks)Population: Participants with data collected at both baseline and end of follow-up (week 26). Data not collected on CCC Counselors.
Change in score of Scale for Suicidal Ideation (SSI). This is a 19 question measure, each item rated from 0-2. Total score is from 0-38, with a higher score indicating greater suicidality concern.
Outcome measures
| Measure |
College Counseling Centers (CCC) Counselors
All Counselors who were consented to this protocol, though none will have completed outcome measures as these do not pertain to this arm.
|
Phase 1 CAMS Responder, Ongoing Maintenance/Monitoring
n=40 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 CAMS
n=19 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 DBT
n=24 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
Phase 1 TAU Responder, Ongoing Maintenance/Monitoring
n=32 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
Treatment As Usual (TAU) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 CAMS
n=30 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
Treatment As Usual (TAU) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 DBT
n=24 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
Treatment As Usual (TAU) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
|---|---|---|---|---|---|---|---|
|
Suicide Ideation - Follow-up (Week 26)
|
—
|
-8.07 score on a scale
Standard Deviation 7.43
|
-6.95 score on a scale
Standard Deviation 8.53
|
-8.83 score on a scale
Standard Deviation 8.72
|
-9.66 score on a scale
Standard Deviation 7.00
|
-9.67 score on a scale
Standard Deviation 8.66
|
-9.79 score on a scale
Standard Deviation 9.26
|
PRIMARY outcome
Timeframe: From baseline to the end of Phase 1 (up to 6 weeks)Population: Participants with data collected and at least 1 NSSI reported at the end of Phase 1 (6 weeks). Data not collected on CCC Counselors.
Count is based on SITBI NSSI section, item 15 "How many episodes since the last assessment have you hurt yourself without wanting to die?" completed by the independent evaluators.
Outcome measures
| Measure |
College Counseling Centers (CCC) Counselors
All Counselors who were consented to this protocol, though none will have completed outcome measures as these do not pertain to this arm.
|
Phase 1 CAMS Responder, Ongoing Maintenance/Monitoring
n=11 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 CAMS
n=14 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 DBT
n=10 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
Phase 1 TAU Responder, Ongoing Maintenance/Monitoring
n=19 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
Treatment As Usual (TAU) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 CAMS
n=13 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
Treatment As Usual (TAU) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 DBT
n=16 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
Treatment As Usual (TAU) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
|---|---|---|---|---|---|---|---|
|
Total Occurrences of Self-Reported Non-Suicidal Self Injury (NSSI) on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Phase 1
|
—
|
247 self-reported NSSIs
|
90 self-reported NSSIs
|
249 self-reported NSSIs
|
45 self-reported NSSIs
|
188 self-reported NSSIs
|
125 self-reported NSSIs
|
PRIMARY outcome
Timeframe: From baseline to the end of Phase 2 (up to 14 weeks)Population: Participants with data collected and at least 1 NSSI reported at the end of Phase 2 (up to 14 weeks). Data not collected on CCC Counselors.
Count is based on SITBI NSSI section, item 15 "How many episodes since the last assessment have you hurt yourself without wanting to die?" completed by the independent evaluators.
Outcome measures
| Measure |
College Counseling Centers (CCC) Counselors
All Counselors who were consented to this protocol, though none will have completed outcome measures as these do not pertain to this arm.
|
Phase 1 CAMS Responder, Ongoing Maintenance/Monitoring
n=21 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 CAMS
n=14 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 DBT
n=16 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
Phase 1 TAU Responder, Ongoing Maintenance/Monitoring
n=22 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
Treatment As Usual (TAU) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 CAMS
n=17 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
Treatment As Usual (TAU) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 DBT
n=13 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
Treatment As Usual (TAU) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
|---|---|---|---|---|---|---|---|
|
Total Occurrences of Self-Reported Non-Suicidal Self Injury (NSSI) on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Phase 2
|
—
|
350 self-reported NSSIs
|
278 self-reported NSSIs
|
467 self-reported NSSIs
|
75 self-reported NSSIs
|
441 self-reported NSSIs
|
217 self-reported NSSIs
|
PRIMARY outcome
Timeframe: From baseline to the end of follow-up (up to 26 weeks)Population: Participants with data collected and at least 1 NSSI reported at the end of follow-up (26 weeks). Data not collected on CCC Counselors.
Count is based on SITBI NSSI section, item 15 "How many episodes since the last assessment have you hurt yourself without wanting to die?" completed by the independent evaluators.
Outcome measures
| Measure |
College Counseling Centers (CCC) Counselors
All Counselors who were consented to this protocol, though none will have completed outcome measures as these do not pertain to this arm.
|
Phase 1 CAMS Responder, Ongoing Maintenance/Monitoring
n=18 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 CAMS
n=23 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 DBT
n=15 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
Phase 1 TAU Responder, Ongoing Maintenance/Monitoring
n=13 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
Treatment As Usual (TAU) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 CAMS
n=22 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
Treatment As Usual (TAU) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 DBT
n=16 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
Treatment As Usual (TAU) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
|---|---|---|---|---|---|---|---|
|
Total Occurrences of Self-Reported Non-Suicidal Self Injury (NSSI) on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Follow-up
|
—
|
401 self-reported NSSIs
|
325 self-reported NSSIs
|
677 self-reported NSSIs
|
90 self-reported NSSIs
|
452 self-reported NSSIs
|
401 self-reported NSSIs
|
PRIMARY outcome
Timeframe: From baseline to the end of Phase 1 (up to 6 weeks)Population: Participants with data collected at the end of Phase 1 (6 weeks). Data not collected on CCC Counselors.
Count is based on SITBI suicide attempt section, items 1 and 6. Item 6 asks "Since the last assessment, have you tried to kill yourself? In other words, have you purposefully hurt yourself with some intent to die?" If they answered yes, then item 6 is asked "How many suicide attempts have you made since the last assessment?" by the independent evaluators.
Outcome measures
| Measure |
College Counseling Centers (CCC) Counselors
All Counselors who were consented to this protocol, though none will have completed outcome measures as these do not pertain to this arm.
|
Phase 1 CAMS Responder, Ongoing Maintenance/Monitoring
n=44 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 CAMS
n=22 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 DBT
n=28 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
Phase 1 TAU Responder, Ongoing Maintenance/Monitoring
n=38 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
Treatment As Usual (TAU) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 CAMS
n=35 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
Treatment As Usual (TAU) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 DBT
n=30 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
Treatment As Usual (TAU) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
|---|---|---|---|---|---|---|---|
|
Total Occurrences of Suicide Attempt on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Phase 1
|
—
|
0 suicide attempts
|
3 suicide attempts
|
2 suicide attempts
|
2 suicide attempts
|
10 suicide attempts
|
1 suicide attempts
|
PRIMARY outcome
Timeframe: From baseline to the end of Phase 2 (up to 14 weeks)Population: Participants with data collected at the end of Phase 2 (up to 14 weeks). Data not collected on CCC Counselors.
Count is based on SITBI suicide attempt section, items 1 and 6. Item 6 asks "Since the last assessment, have you tried to kill yourself? In other words, have you purposefully hurt yourself with some intent to die?" If they answered yes, then item 6 is asked "How many suicide attempts have you made since the last assessment?" by the independent evaluators.
Outcome measures
| Measure |
College Counseling Centers (CCC) Counselors
All Counselors who were consented to this protocol, though none will have completed outcome measures as these do not pertain to this arm.
|
Phase 1 CAMS Responder, Ongoing Maintenance/Monitoring
n=45 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 CAMS
n=23 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 DBT
n=29 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
Phase 1 TAU Responder, Ongoing Maintenance/Monitoring
n=39 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
Treatment As Usual (TAU) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 CAMS
n=35 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
Treatment As Usual (TAU) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 DBT
n=32 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
Treatment As Usual (TAU) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
|---|---|---|---|---|---|---|---|
|
Total Occurrences of Suicide Attempt on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Phase 2
|
—
|
0 suicide attempts
|
4 suicide attempts
|
3 suicide attempts
|
9 suicide attempts
|
10 suicide attempts
|
3 suicide attempts
|
PRIMARY outcome
Timeframe: From baseline to the end of follow-up (up to 26 weeks)Population: Participants with data collected at the end of follow-up (26 weeks). Data not collected on CCC Counselors.
Count is based on SITBI suicide attempt section, items 1 and 6. Item 6 asks "Since the last assessment, have you tried to kill yourself? In other words, have you purposefully hurt yourself with some intent to die?" If they answered yes, then item 6 is asked "How many suicide attempts have you made since the last assessment?" by the independent evaluators.
Outcome measures
| Measure |
College Counseling Centers (CCC) Counselors
All Counselors who were consented to this protocol, though none will have completed outcome measures as these do not pertain to this arm.
|
Phase 1 CAMS Responder, Ongoing Maintenance/Monitoring
n=45 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 CAMS
n=23 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 CAMS Insufficient Responder, Phase 2 DBT
n=29 Participants
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
Phase 1 TAU Responder, Ongoing Maintenance/Monitoring
n=39 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
Treatment As Usual (TAU) - Phase 1
Maintenance/Monitoring - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 CAMS
n=35 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
Treatment As Usual (TAU) - Phase 1
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
Phase 1 TAU Insufficient Responder, Phase 2 DBT
n=32 Participants
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
Treatment As Usual (TAU) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
|
|---|---|---|---|---|---|---|---|
|
Total Occurrences of Suicide Attempt on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Follow-up
|
—
|
0 suicide attempts
|
8 suicide attempts
|
3 suicide attempts
|
9 suicide attempts
|
10 suicide attempts
|
5 suicide attempts
|
Adverse Events
Phase 2 CAMS Maintenance Only
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2 TAU Maintenance Only
Serious events: 8 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 2 CAMS
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2 Dialectical Behavior Therapy (DBT)
Serious events: 10 serious events
Other events: 9 other events
Deaths: 0 deaths
Phase 1 Collaborative Assessment and Management of Suicidality (CAMS)
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1 Treatment As Usual (TAU)
Serious events: 8 serious events
Other events: 7 other events
Deaths: 0 deaths
College Counseling Center (CCC) Counselors
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 2 CAMS Maintenance Only
n=47 participants at risk
Phase 2 Ongoing Maintenance/Monitoring
|
Phase 2 TAU Maintenance Only
n=40 participants at risk
Phase 2 Ongoing Maintenance/Monitoring
|
Phase 2 CAMS
n=66 participants at risk
Phase 2 Collaborative Assessment and Management of Suicidality (CAMS): a suicide-focused treatment
|
Phase 2 Dialectical Behavior Therapy (DBT)
n=74 participants at risk
Phase 2 Dialectical Behavior Therapy (DBT): includes individual therapy, skills group, and phone/text coaching
|
Phase 1 Collaborative Assessment and Management of Suicidality (CAMS)
n=113 participants at risk
Phase 1 Collaborative Assessment and Management of Suicidality (CAMS): a suicide-focused treatment
|
Phase 1 Treatment As Usual (TAU)
n=114 participants at risk
Treatment As Usual (TAU): treatment as usual
|
College Counseling Center (CCC) Counselors
All Counselors who were consented to this protocol, though none will have completed outcome measures as these do not pertain to this arm.
|
|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/47 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
7.5%
3/40 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
6.1%
4/66 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
6.8%
5/74 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/113 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
4.4%
5/114 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
—
0/0 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
|
Psychiatric disorders
ED visit suicide attempt
|
0.00%
0/47 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/40 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/66 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/74 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/113 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.88%
1/114 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
—
0/0 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
|
Psychiatric disorders
ED visit suicidal ideation
|
0.00%
0/47 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/40 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/66 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
4.1%
3/74 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/113 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.88%
1/114 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
—
0/0 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
|
Psychiatric disorders
ED visit other mental heath event
|
0.00%
0/47 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
10.0%
4/40 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/66 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
1.4%
1/74 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
3.5%
4/113 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.88%
1/114 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
—
0/0 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
|
General disorders
Medication adverse reaction
|
0.00%
0/47 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/40 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/66 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/74 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/113 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/114 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
—
0/0 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/47 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/40 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/66 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/74 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/113 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/114 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
—
0/0 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/47 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/40 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/66 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/74 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/113 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/114 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
—
0/0 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma/difficulty breathing
|
0.00%
0/47 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/40 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/66 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/74 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/113 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/114 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
—
0/0 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/47 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/40 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/66 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/74 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/113 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/114 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
—
0/0 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
|
Psychiatric disorders
ED visit non-suicidal self injury (NSSI)
|
0.00%
0/47 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/40 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/66 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/74 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/113 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.88%
1/114 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
—
0/0 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
|
Psychiatric disorders
Inpatient hospitalization suicide attempt
|
8.5%
4/47 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
2.5%
1/40 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/66 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/74 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/113 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/114 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
—
0/0 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
|
Psychiatric disorders
Inpatient hospitalization suicidal ideation
|
2.1%
1/47 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/40 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/66 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
1.4%
1/74 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/113 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/114 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
—
0/0 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/47 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/40 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/66 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/74 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/113 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/114 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
—
0/0 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
Other adverse events
| Measure |
Phase 2 CAMS Maintenance Only
n=47 participants at risk
Phase 2 Ongoing Maintenance/Monitoring
|
Phase 2 TAU Maintenance Only
n=40 participants at risk
Phase 2 Ongoing Maintenance/Monitoring
|
Phase 2 CAMS
n=66 participants at risk
Phase 2 Collaborative Assessment and Management of Suicidality (CAMS): a suicide-focused treatment
|
Phase 2 Dialectical Behavior Therapy (DBT)
n=74 participants at risk
Phase 2 Dialectical Behavior Therapy (DBT): includes individual therapy, skills group, and phone/text coaching
|
Phase 1 Collaborative Assessment and Management of Suicidality (CAMS)
n=113 participants at risk
Phase 1 Collaborative Assessment and Management of Suicidality (CAMS): a suicide-focused treatment
|
Phase 1 Treatment As Usual (TAU)
n=114 participants at risk
Treatment As Usual (TAU): treatment as usual
|
College Counseling Center (CCC) Counselors
All Counselors who were consented to this protocol, though none will have completed outcome measures as these do not pertain to this arm.
|
|---|---|---|---|---|---|---|---|
|
Social circumstances
Breach of confidentiality
|
0.00%
0/47 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/40 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/66 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
1.4%
1/74 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
1.8%
2/113 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.88%
1/114 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
—
0/0 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
|
Psychiatric disorders
Evidence of distress during assessments
|
4.3%
2/47 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
10.0%
4/40 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
4.5%
3/66 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
5.4%
4/74 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
1.8%
2/113 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
3.5%
4/114 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
—
0/0 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
|
Psychiatric disorders
Significant increase in suicidal ideation
|
8.5%
4/47 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.00%
0/40 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
4.5%
3/66 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
5.4%
4/74 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
0.88%
1/113 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
1.8%
2/114 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
—
0/0 • Up to 26 weeks
Participants were asked directly about AEs and SAEs by independent evaluators (IEs) at each assessment point (i.e., systematic assessment). Additionally, any AEs or SAEs mentioned spontaneously by a participant during a therapy session were reported by treating therapists (i.e., non-systematic assessment). Data not collected on CCC Counselors.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place