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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

61 participants

Primary outcome timeframe

Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention

Results posted on

2025-07-30

Participant Flow

Participant milestones

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

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

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 Intervention

Population: 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

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

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

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

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

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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard Group, Full Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Capitalization Group, Brief Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Capitalization Group, Full Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Compensation Group, Brief Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Compensation Group, Full Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sauer-Zavala

University of Kentucky

Phone: 859-562-1571

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place