Trial Outcomes & Findings for Cognitive Behavioral Suicide Prevention for Psychosis: Aim 2 (NCT NCT05345184)
NCT ID: NCT05345184
Last Updated: 2026-03-20
Results Overview
A scale to measure depression, higher scores indicate greater depression (range of 0-27)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).
Results posted on
2026-03-20
Participant Flow
Participant milestones
| Measure |
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions in addition to standard/current services.
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp): Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis
|
Services as Usual (SAU; Comparison Group)
Services as usual involve standard and current services that clients are eligible for receiving.
Services as Usual (SAU): Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management)
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
26
|
|
Overall Study
COMPLETED
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Behavioral Suicide Prevention for Psychosis: Aim 2
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)
n=25 Participants
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions in addition to standard/current services.
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp): Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis
|
Services as Usual (SAU; Comparison Group)
n=26 Participants
Services as usual involve standard and current services that clients are eligible for receiving.
Services as Usual (SAU): Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management)
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.99 years
STANDARD_DEVIATION 12.35 • n=154 Participants
|
44.05 years
STANDARD_DEVIATION 13.61 • n=151 Participants
|
44.52 years
STANDARD_DEVIATION 12.98 • n=305 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=154 Participants
|
9 Participants
n=151 Participants
|
20 Participants
n=305 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=154 Participants
|
17 Participants
n=151 Participants
|
31 Participants
n=305 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=154 Participants
|
5 Participants
n=151 Participants
|
5 Participants
n=305 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=154 Participants
|
19 Participants
n=151 Participants
|
39 Participants
n=305 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=154 Participants
|
2 Participants
n=151 Participants
|
7 Participants
n=305 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
1 Participants
n=305 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
1 Participants
n=305 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=154 Participants
|
10 Participants
n=151 Participants
|
17 Participants
n=305 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=154 Participants
|
16 Participants
n=151 Participants
|
32 Participants
n=305 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=154 Participants
|
26 participants
n=151 Participants
|
51 participants
n=305 Participants
|
|
Columbia Suicide Severity Rating Scale
|
2.52 units on a scale
STANDARD_DEVIATION 1.23 • n=154 Participants
|
1.77 units on a scale
STANDARD_DEVIATION 1.56 • n=151 Participants
|
2.15 units on a scale
STANDARD_DEVIATION 1.39 • n=305 Participants
|
PRIMARY outcome
Timeframe: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).Population: Adults with schizophrenia spectrum disorders and suicide ideation and/or attempt history
A scale to measure depression, higher scores indicate greater depression (range of 0-27)
Outcome measures
| Measure |
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)
n=25 Participants
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions in addition to standard/current services.
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp): Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis
|
Services as Usual (SAU; Comparison Group)
n=26 Participants
Services as usual involve standard and current services that clients are eligible for receiving.
Services as Usual (SAU): Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management)
|
|---|---|---|
|
Calgary Depression Rating Scale (CDRS)
Post-treatment
|
13.95 score on a scale
Standard Deviation 3.20
|
15.83 score on a scale
Standard Deviation 5.26
|
|
Calgary Depression Rating Scale (CDRS)
Follow-up
|
13.55 score on a scale
Standard Deviation 3.59
|
14.19 score on a scale
Standard Deviation 3.68
|
|
Calgary Depression Rating Scale (CDRS)
Baseline
|
18.20 score on a scale
Standard Deviation 4.65
|
17.15 score on a scale
Standard Deviation 4.58
|
|
Calgary Depression Rating Scale (CDRS)
Mid-treatment
|
16.09 score on a scale
Standard Deviation 3.78
|
15.39 score on a scale
Standard Deviation 4.59
|
PRIMARY outcome
Timeframe: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).Population: Adults with schizophrenia spectrum disorders and suicide ideation and/or attempt history
A scale to measure psychosis symptoms, higher scores indicate greater psychosis (range of 30-210)
Outcome measures
| Measure |
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)
n=25 Participants
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions in addition to standard/current services.
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp): Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis
|
Services as Usual (SAU; Comparison Group)
n=26 Participants
Services as usual involve standard and current services that clients are eligible for receiving.
Services as Usual (SAU): Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management)
|
|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS)
mid-treatment
|
77.68 score on a scale
Standard Deviation 12.64
|
71.69 score on a scale
Standard Deviation 16.29
|
|
Positive and Negative Syndrome Scale (PANSS)
post-treatment
|
71.57 score on a scale
Standard Deviation 12.64
|
76.96 score on a scale
Standard Deviation 16.92
|
|
Positive and Negative Syndrome Scale (PANSS)
follow-up
|
74.40 score on a scale
Standard Deviation 17.58
|
71.09 score on a scale
Standard Deviation 13.71
|
|
Positive and Negative Syndrome Scale (PANSS)
baseline
|
82.72 score on a scale
Standard Deviation 13.58
|
75.27 score on a scale
Standard Deviation 15.79
|
PRIMARY outcome
Timeframe: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).Population: Adults with schizophrenia spectrum disorders and suicide ideation and/or attempt history
A scale to measure suicide thoughts and behavior, higher scores indicate greater suicide thoughts and behavior (range of 0-5)
Outcome measures
| Measure |
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)
n=25 Participants
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions in addition to standard/current services.
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp): Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis
|
Services as Usual (SAU; Comparison Group)
n=26 Participants
Services as usual involve standard and current services that clients are eligible for receiving.
Services as Usual (SAU): Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management)
|
|---|---|---|
|
Columbia Suicide Severity Rating Scale (C-SSRS)
mid-treatment
|
1.45 score on a scale
Standard Deviation 1.65
|
1.48 score on a scale
Standard Deviation 1.34
|
|
Columbia Suicide Severity Rating Scale (C-SSRS)
post-treatment
|
1.09 score on a scale
Standard Deviation 1.51
|
1.52 score on a scale
Standard Deviation 1.68
|
|
Columbia Suicide Severity Rating Scale (C-SSRS)
follow-up
|
1.05 score on a scale
Standard Deviation 1.50
|
.86 score on a scale
Standard Deviation 1.19
|
|
Columbia Suicide Severity Rating Scale (C-SSRS)
baseline
|
2.52 score on a scale
Standard Deviation 1.23
|
1.77 score on a scale
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).Population: Adults with schizophrenia spectrum disorders and suicide ideation and/or attempt history
A scale to measure hopelessness, higher scores indicate greater hopelessness (range of 0-20)
Outcome measures
| Measure |
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)
n=25 Participants
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions in addition to standard/current services.
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp): Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis
|
Services as Usual (SAU; Comparison Group)
n=26 Participants
Services as usual involve standard and current services that clients are eligible for receiving.
Services as Usual (SAU): Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management)
|
|---|---|---|
|
Beck Hopelessness Scale
baseline
|
7.04 score on a scale
Standard Deviation 5.33
|
7.85 score on a scale
Standard Deviation 5.65
|
|
Beck Hopelessness Scale
mid-treatment
|
5.67 score on a scale
Standard Deviation 4.72
|
7.0 score on a scale
Standard Deviation 5.46
|
|
Beck Hopelessness Scale
post-treatment
|
4.0 score on a scale
Standard Deviation 3.63
|
7.26 score on a scale
Standard Deviation 5.82
|
|
Beck Hopelessness Scale
follow-up
|
4.60 score on a scale
Standard Deviation 5.28
|
6.0 score on a scale
Standard Deviation 5.97
|
SECONDARY outcome
Timeframe: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).Population: Adults with schizophrenia spectrum disorders and suicide ideation and/or attempt history
A scale to measure defeat, higher scores indicate greater defeat (range of 0-64)
Outcome measures
| Measure |
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)
n=25 Participants
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions in addition to standard/current services.
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp): Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis
|
Services as Usual (SAU; Comparison Group)
n=26 Participants
Services as usual involve standard and current services that clients are eligible for receiving.
Services as Usual (SAU): Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management)
|
|---|---|---|
|
Defeat Scale (D Scale)
baseline
|
31.24 score on a scale
Standard Deviation 15.86
|
32.19 score on a scale
Standard Deviation 12.76
|
|
Defeat Scale (D Scale)
mid-treatment
|
27.57 score on a scale
Standard Deviation 14.28
|
28.52 score on a scale
Standard Deviation 14.80
|
|
Defeat Scale (D Scale)
post-treatment
|
22.71 score on a scale
Standard Deviation 13.12
|
27.61 score on a scale
Standard Deviation 13.71
|
|
Defeat Scale (D Scale)
follow-up
|
22.65 score on a scale
Standard Deviation 15.23
|
27.90 score on a scale
Standard Deviation 15.05
|
SECONDARY outcome
Timeframe: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).Population: Adults with schizophrenia spectrum disorders and suicide ideation and/or attempt history
A scale to measure entrapment, higher scores indicate greater entrapment (range of 0-64)
Outcome measures
| Measure |
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)
n=25 Participants
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions in addition to standard/current services.
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp): Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis
|
Services as Usual (SAU; Comparison Group)
n=26 Participants
Services as usual involve standard and current services that clients are eligible for receiving.
Services as Usual (SAU): Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management)
|
|---|---|---|
|
The Entrapment Scale
baseline
|
28.12 score on a scale
Standard Deviation 17.84
|
22.04 score on a scale
Standard Deviation 14.96
|
|
The Entrapment Scale
mid-treatment
|
27.62 score on a scale
Standard Deviation 18.63
|
23.83 score on a scale
Standard Deviation 16.34
|
|
The Entrapment Scale
post-treatment
|
18.33 score on a scale
Standard Deviation 15.60
|
27.14 score on a scale
Standard Deviation 16.28
|
|
The Entrapment Scale
follow-up
|
17.55 score on a scale
Standard Deviation 15.15
|
24.0 score on a scale
Standard Deviation 16.46
|
Adverse Events
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Services as Usual (SAU; Comparison Group)
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)
n=25 participants at risk
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions in addition to standard/current services.
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp): Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis
|
Services as Usual (SAU; Comparison Group)
n=26 participants at risk
Services as usual involve standard and current services that clients are eligible for receiving.
Services as Usual (SAU): Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management)
|
|---|---|---|
|
Psychiatric disorders
Psychiatric hospitalization
|
4.0%
1/25 • Number of events 1 • between baseline assessment at 5 month assessment (follow up)
AEs are events that involve physical, social, economic, or psychological harm to subjects; or indicate the possibility of harm to others.
|
15.4%
4/26 • Number of events 4 • between baseline assessment at 5 month assessment (follow up)
AEs are events that involve physical, social, economic, or psychological harm to subjects; or indicate the possibility of harm to others.
|
|
General disorders
Medical hospitalization
|
4.0%
1/25 • Number of events 1 • between baseline assessment at 5 month assessment (follow up)
AEs are events that involve physical, social, economic, or psychological harm to subjects; or indicate the possibility of harm to others.
|
3.8%
1/26 • Number of events 1 • between baseline assessment at 5 month assessment (follow up)
AEs are events that involve physical, social, economic, or psychological harm to subjects; or indicate the possibility of harm to others.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place