Trial Outcomes & Findings for Increasing Treatment Efficacy Using SMART Methods for Personalizing Care (NCT NCT04642898)
NCT ID: NCT04642898
Last Updated: 2025-07-30
Results Overview
Clinical severity will be measured using the Diagnostic Interview for Anxiety, Mood, and Obsessive Compulsive and Related Neuropsychiatric Disorders (DIAMOND) dimensional clinician ratings. Scores range from 1-7; higher scores indicate greater severity. Negative scores indicate symptom improvement.
COMPLETED
NA
61 participants
Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention
2025-07-30
Participant Flow
Participant milestones
| Measure |
Standard Group, Brief Intervention
Participants in this group will receive 6 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard UP Treatment: Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
|
Standard Group, Full Intervention
Participants in this group will receive 12 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard UP Treatment: Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
|
Capitalization Group, Brief Intervention
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
|
Capitalization Group, Full Intervention
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
|
Compensation Group, Brief Intervention
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
|
Compensation Group, Full Intervention
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
6
|
6
|
2
|
7
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
4
|
8
|
3
|
8
|
Reasons for withdrawal
| Measure |
Standard Group, Brief Intervention
Participants in this group will receive 6 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard UP Treatment: Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
|
Standard Group, Full Intervention
Participants in this group will receive 12 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard UP Treatment: Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
|
Capitalization Group, Brief Intervention
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
|
Capitalization Group, Full Intervention
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
|
Compensation Group, Brief Intervention
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
|
Compensation Group, Full Intervention
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
4
|
6
|
2
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
2
|
0
|
1
|
|
Overall Study
Therapist left trial before patient completed treatment
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Ineligible due to conflict of interest with therapist
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
1 participant in the standard group, full intervention did not complete the demographic info survey and 1 participant in the compensation group, brief intervention did not report their age
Baseline characteristics by cohort
| Measure |
Standard Group, Brief Intervention
n=11 Participants
Participants in this group will receive 6 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard UP Treatment: Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
|
Standard Group, Full Intervention
n=10 Participants
Participants in this group will receive 12 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard UP Treatment: Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
|
Capitalization Group, Brief Intervention
n=10 Participants
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
|
Capitalization Group, Full Intervention
n=10 Participants
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
|
Compensation Group, Brief Intervention
n=10 Participants
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
|
Compensation Group, Full Intervention
n=10 Participants
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.36 years
STANDARD_DEVIATION 8.87 • n=11 Participants • 1 participant in the standard group, full intervention did not complete the demographic info survey and 1 participant in the compensation group, brief intervention did not report their age
|
39.67 years
STANDARD_DEVIATION 14.55 • n=9 Participants • 1 participant in the standard group, full intervention did not complete the demographic info survey and 1 participant in the compensation group, brief intervention did not report their age
|
44.60 years
STANDARD_DEVIATION 15.10 • n=10 Participants • 1 participant in the standard group, full intervention did not complete the demographic info survey and 1 participant in the compensation group, brief intervention did not report their age
|
36.10 years
STANDARD_DEVIATION 10.84 • n=10 Participants • 1 participant in the standard group, full intervention did not complete the demographic info survey and 1 participant in the compensation group, brief intervention did not report their age
|
36.78 years
STANDARD_DEVIATION 10.84 • n=9 Participants • 1 participant in the standard group, full intervention did not complete the demographic info survey and 1 participant in the compensation group, brief intervention did not report their age
|
37.50 years
STANDARD_DEVIATION 13.19 • n=10 Participants • 1 participant in the standard group, full intervention did not complete the demographic info survey and 1 participant in the compensation group, brief intervention did not report their age
|
37.92 years
STANDARD_DEVIATION 12.35 • n=59 Participants • 1 participant in the standard group, full intervention did not complete the demographic info survey and 1 participant in the compensation group, brief intervention did not report their age
|
|
Sex: Female, Male
Female
|
9 Participants
n=11 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
6 Participants
n=9 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
8 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
8 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
8 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
6 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
45 Participants
n=60 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
|
Sex: Female, Male
Male
|
2 Participants
n=11 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
3 Participants
n=9 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
2 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
2 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
2 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
4 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
15 Participants
n=60 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=11 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
0 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
0 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
1 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
0 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
0 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
2 Participants
n=61 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=11 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
9 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
10 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
9 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
10 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
10 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
58 Participants
n=61 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
1 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
0 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
0 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
0 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
0 Participants
n=10 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
1 Participants
n=61 Participants • 1 participant in the standard group, full intervention did not fill out the demographics form
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=61 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=11 Participants
|
7 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
9 Participants
n=10 Participants
|
9 Participants
n=10 Participants
|
9 Participants
n=10 Participants
|
53 Participants
n=61 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=11 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=61 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=11 Participants
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
61 participants
n=61 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full InterventionPopulation: Outcomes for participants in brief intervention groups will be the difference in clinical severity at assessments before and after 6 sessions of treatment. Outcomes for participants in full intervention groups will be the difference in clinical severity at assessments before and after 12 sessions of treatment. Participants who completed their pre- and post-treatment clinician assessment meetings were analyzed.
Clinical severity will be measured using the Diagnostic Interview for Anxiety, Mood, and Obsessive Compulsive and Related Neuropsychiatric Disorders (DIAMOND) dimensional clinician ratings. Scores range from 1-7; higher scores indicate greater severity. Negative scores indicate symptom improvement.
Outcome measures
| Measure |
Standard Group, Brief Intervention
n=10 Participants
Participants in this group will receive 6 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard UP Treatment: Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
|
Standard Group, Full Intervention
n=7 Participants
Participants in this group will receive 12 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard UP Treatment: Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
|
Capitalization Group, Brief Intervention
n=7 Participants
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
|
Capitalization Group, Full Intervention
n=2 Participants
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
|
Compensation Group, Brief Intervention
n=7 Participants
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
|
Compensation Group, Full Intervention
n=3 Participants
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
|
|---|---|---|---|---|---|---|
|
Change in Clinical Severity From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
|
-2.40 score on a scale
Standard Deviation 1.26
|
-2.86 score on a scale
Standard Deviation 1.46
|
-2.71 score on a scale
Standard Deviation 1.25
|
-2.00 score on a scale
Standard Deviation 1.14
|
-3.00 score on a scale
Standard Deviation 1.15
|
-3.33 score on a scale
Standard Deviation .58
|
PRIMARY outcome
Timeframe: Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention)Population: Outcomes for participants in brief intervention groups is the difference in self-reported anxiety symptoms before and after 6 treatment sessions and outcomes for participants in full intervention groups is the difference in scores before and after 12 sessions. Participants who completed the pre- and post-treatment assessment questionnaires were analyzed. Several participants completed the post-treatment clinician meeting but not the questionnaires, creating a disparity in sample across outcomes
Anxiety symptoms will be measured using the Overall Anxiety Severity and Interference Scale (OASIS). This is a self-report measure in which scores range from 0-20; higher scores indicate more severe anxiety symptoms. Negative scores indicate symptom improvement. assessed at baseline and weekly for 6 or 12 weeks, change from baseline after 6 sessions (6 weeks) and after 12 sessions (12 weeks) are being reported
Outcome measures
| Measure |
Standard Group, Brief Intervention
n=9 Participants
Participants in this group will receive 6 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard UP Treatment: Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
|
Standard Group, Full Intervention
n=7 Participants
Participants in this group will receive 12 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard UP Treatment: Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
|
Capitalization Group, Brief Intervention
n=5 Participants
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
|
Capitalization Group, Full Intervention
n=1 Participants
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
|
Compensation Group, Brief Intervention
n=6 Participants
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
|
Compensation Group, Full Intervention
n=2 Participants
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
|
|---|---|---|---|---|---|---|
|
Change in Self-Reported Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
|
-2.56 score on a scale
Standard Error 2.40
|
-1.57 score on a scale
Standard Error 4.69
|
-2.00 score on a scale
Standard Error 2.74
|
-2.00 score on a scale
Standard Error 0
|
-3.33 score on a scale
Standard Error 2.66
|
-7.50 score on a scale
Standard Error .71
|
PRIMARY outcome
Timeframe: Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention)Population: Outcomes for participants in brief intervention groups is the difference in self-reported symptoms before and after 6 treatment sessions and outcomes for participants in full intervention groups is the difference in scores before and after 12 sessions. Participants who completed the pre- and post-treatment assessment questionnaires were analyzed. Several participants completed the post-treatment clinician meeting but not the questionnaires, creating a disparity in sample across outcomes
Depressive symptoms will be measured using the Overall Depression Severity and Interference Scale (ODSIS). This is a self-report measure in which scores range from 0-20; higher scores indicate more severe anxiety symptoms. Negative scores indicate symptom improvement. assessed at baseline and weekly for 6 or 12 weeks, change from baseline after 6 sessions (6 weeks) and after 12 sessions (12 weeks) are being reported
Outcome measures
| Measure |
Standard Group, Brief Intervention
n=9 Participants
Participants in this group will receive 6 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard UP Treatment: Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
|
Standard Group, Full Intervention
n=7 Participants
Participants in this group will receive 12 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard UP Treatment: Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
|
Capitalization Group, Brief Intervention
n=5 Participants
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
|
Capitalization Group, Full Intervention
n=1 Participants
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
|
Compensation Group, Brief Intervention
n=6 Participants
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
|
Compensation Group, Full Intervention
n=2 Participants
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
|
|---|---|---|---|---|---|---|
|
Change in Self-Reported Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
|
0 score on a scale
Standard Deviation 4.58
|
-1.57 score on a scale
Standard Deviation 6.32
|
-1.20 score on a scale
Standard Deviation 3.56
|
-4.00 score on a scale
Standard Deviation 0
|
-1.67 score on a scale
Standard Deviation 4.41
|
-3.00 score on a scale
Standard Deviation 1.41
|
PRIMARY outcome
Timeframe: Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention)Population: Outcomes for participants in brief intervention groups is the difference in self-reported symptoms before and after 6 treatment sessions and outcomes for participants in full intervention groups is the difference in scores before and after 12 sessions. Participants who completed the pre- and post-treatment assessment questionnaires were analyzed. Several participants completed the post-treatment clinician meeting but not the questionnaires, creating a disparity in sample across outcomes
Aversive reactions to emotions will be measured using the distress aversion subscale of the Multidimensional Experiential Avoidance Questionnaire (MEAQ). This is a self-report measure in which scores range from 13-78; higher scores indicate greater negative reactions to emotional experiences. Negative scores indicate symptom improvement. assessed at baseline and weekly for 6 or 12 weeks, change from baseline after 6 sessions (6 weeks) and after 12 sessions (12 weeks) are being reported
Outcome measures
| Measure |
Standard Group, Brief Intervention
n=9 Participants
Participants in this group will receive 6 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard UP Treatment: Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
|
Standard Group, Full Intervention
n=7 Participants
Participants in this group will receive 12 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard UP Treatment: Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
|
Capitalization Group, Brief Intervention
n=5 Participants
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
|
Capitalization Group, Full Intervention
n=1 Participants
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
|
Compensation Group, Brief Intervention
n=6 Participants
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
|
Compensation Group, Full Intervention
n=2 Participants
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
|
|---|---|---|---|---|---|---|
|
Change in Self-Reported Aversive Reactions to Emotions From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
|
-4.44 score on a scale
Standard Deviation 9.54
|
-7.14 score on a scale
Standard Deviation 6.79
|
-3.40 score on a scale
Standard Deviation 8.65
|
-2.00 score on a scale
Standard Deviation 0
|
-6.83 score on a scale
Standard Deviation 8.15
|
-18.50 score on a scale
Standard Deviation 6.36
|
PRIMARY outcome
Timeframe: Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention)Population: Participants who completed the pre- and post-treatment clinician assessment meetings. Several participants completed the post-treatment clinician assessment, but did not complete the associated questionnaire batteries, which is why there is a disparity in the number of participants analyzed across outcome measures.
Clinician-rated anxiety symptoms will be measured using the Hamilton Rating Scale for Anxiety Symptoms. Scores range from 0-56; higher scores indicate greater severity. Negative scores indicate symptom improvement. Outcomes for participants in brief intervention groups is the difference in clinician rated symptom scores before and after 6 treatment sessions and outcomes for participants in full intervention groups is the difference in clinician rated symptom scores before and after 12 sessions.
Outcome measures
| Measure |
Standard Group, Brief Intervention
n=10 Participants
Participants in this group will receive 6 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard UP Treatment: Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
|
Standard Group, Full Intervention
n=7 Participants
Participants in this group will receive 12 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard UP Treatment: Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
|
Capitalization Group, Brief Intervention
n=7 Participants
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
|
Capitalization Group, Full Intervention
n=2 Participants
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
|
Compensation Group, Brief Intervention
n=7 Participants
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
|
Compensation Group, Full Intervention
n=3 Participants
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
|
|---|---|---|---|---|---|---|
|
Change in Clinician-Rated Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
|
-3.6 score on a scale
Standard Deviation 6.99
|
-2.57 score on a scale
Standard Deviation 7.5
|
-8.29 score on a scale
Standard Deviation 8.53
|
-8.50 score on a scale
Standard Deviation 7.78
|
-6.00 score on a scale
Standard Deviation 4.90
|
-5.00 score on a scale
Standard Deviation 8.19
|
PRIMARY outcome
Timeframe: Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention)Population: Participants who completed the pre- and post-treatment clinician assessment meetings. Several participants completed the post-treatment clinician assessment, but did not complete the associated questionnaire batteries, which is why there is a disparity in the number of participants analyzed across outcome measures.
Clinician-rated depressive symptoms will be measured using the Hamilton Rating Scale for Depressive Symptoms. Scores range from 0-68; higher scores indicate greater severity. Negative scores indicate symptom improvement. Outcomes for participants in brief intervention groups is the difference in Clinician-Rated symptom scores before and after 6 treatment sessions and outcomes for participants in full intervention groups is the difference in Clinician-Rated symptom scores before and after 12 sessions.
Outcome measures
| Measure |
Standard Group, Brief Intervention
n=9 Participants
Participants in this group will receive 6 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard UP Treatment: Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
|
Standard Group, Full Intervention
n=7 Participants
Participants in this group will receive 12 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard UP Treatment: Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
|
Capitalization Group, Brief Intervention
n=7 Participants
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
|
Capitalization Group, Full Intervention
n=2 Participants
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
|
Compensation Group, Brief Intervention
n=7 Participants
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
|
Compensation Group, Full Intervention
n=3 Participants
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation UP Treatment: Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
|
|---|---|---|---|---|---|---|
|
Change in Clinician-Rated Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
|
-1.22 score on a scale
Standard Deviation 3.77
|
-.29 score on a scale
Standard Deviation 7.15
|
-6.86 score on a scale
Standard Deviation 8.23
|
-1.50 score on a scale
Standard Deviation 3.54
|
-3.86 score on a scale
Standard Deviation 5.34
|
-5.00 score on a scale
Standard Deviation 3.46
|
Adverse Events
Standard Group, Brief Intervention
Standard Group, Full Intervention
Capitalization Group, Brief Intervention
Capitalization Group, Full Intervention
Compensation Group, Brief Intervention
Compensation Group, Full Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place