Anxiety Disorders, Obsessive-Compulsive Disorder, Post Traumatic Stress Disorder
Conditions
Keywords
Unified Protocol, Cognitive Behavioral Therapy, Personalization
Brief summary
The proposed study will determine the feasibility, tolerability, and acceptability of a study that tests: 1) personalized treatment delivery (i.e., module sequencing and treatment discontinuation timing) aimed at increasing the efficiency of care, and 2) the research protocol designed to evaluate the effects of this personalized care. A sample of 60 participants with heterogeneous anxiety disorders (and comorbid conditions, including depression) will be enrolled in a pilot sequential multiple assignment randomized trial (SMART). Patients will be randomly assigned to one of three sequencing conditions: transdiagnostic treatment administered in its standard module order, module sequences that prioritize capitalizing on relative strengths, and module sequences that prioritize compensating for relative weaknesses. Next, after 6 sessions, participants will be randomly assigned to either continue or discontinue treatment to evaluate post-treatment change at varying levels of target engagement. This proposal will enable us to 1) test the feasibility, acceptability, and tolerability of the research protocol, treatment sequencing conditions, and early treatment discontinuation, 2) determine whether a preliminary signal that capitalization or compensation module sequencing improves treatment efficiency exists, and 3) explore preliminary associations between core process engagement at treatment discontinuation and later symptom improvement. The proposed study, and the subsequent research it will support, will inform evidence-based decision rules to make existing treatments more efficient, ultimately reducing patient costs and increasing the mental health service system's capacity to address the needs of more individuals.
Interventions
BEHAVIORALCompensation 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.
BEHAVIORALStandard 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).
BEHAVIORALCapitalization 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.
Sponsors
National Institute of Mental Health (NIMH)
Shannon E. Sauer-Zavala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* diagnosis of at least one anxiety disorder, trauma- or stressor-related disorder, or obsessive-compulsive disorder * fluent in English * medication stability
Exclusion criteria
* concurrent therapy * psychological condition that would be better addressed by alternative treatments * have received more than 5 sessions of cognitive behavioral therapy in the past 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Severity From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention | 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. |
| Change in Self-Reported Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention) | 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 |
| Change in Self-Reported Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention) | 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 |
| Change in Self-Reported Aversive Reactions to Emotions From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention) | 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 |
| Change in Clinician-Rated Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention) | 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. |
| Change in Clinician-Rated Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 11 |
| 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). | 10 |
| 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. | 10 |
| 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. | 10 |
| 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. | 10 |
| 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. | 10 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Ineligible due to conflict of interest with therapist | 0 | 0 | 0 | 0 | 1 | 0 |
| 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 | Withdrawal by Subject | 2 | 4 | 4 | 6 | 2 | 6 |
Baseline characteristics
| Characteristic | Standard Group, Brief Intervention | Standard Group, Full Intervention | Capitalization Group, Brief Intervention | Capitalization Group, Full Intervention | Compensation Group, Brief Intervention | Compensation Group, Full Intervention | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 33.36 years STANDARD_DEVIATION 8.87 | 39.67 years STANDARD_DEVIATION 14.55 | 44.60 years STANDARD_DEVIATION 15.1 | 36.10 years STANDARD_DEVIATION 10.84 | 36.78 years STANDARD_DEVIATION 10.84 | 37.50 years STANDARD_DEVIATION 13.19 | 37.92 years STANDARD_DEVIATION 12.35 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 9 Participants | 10 Participants | 9 Participants | 10 Participants | 10 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 9 Participants | 7 Participants | 10 Participants | 9 Participants | 9 Participants | 9 Participants | 53 Participants |
| Region of Enrollment United States | 11 participants | 10 participants | 10 participants | 10 participants | 10 participants | 10 participants | 61 participants |
| Sex: Female, Male Female | 9 Participants | 6 Participants | 8 Participants | 8 Participants | 8 Participants | 6 Participants | 45 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 2 Participants | 4 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 11 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Change in Clinical Severity From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Group, Brief Intervention | 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 |
| Standard Group, Full Intervention | Change in Clinical Severity From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -2.86 score on a scale | Standard Deviation 1.46 |
| Capitalization Group, Brief Intervention | Change in Clinical Severity From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -2.71 score on a scale | Standard Deviation 1.25 |
| Capitalization Group, Full Intervention | Change in Clinical Severity From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -2.00 score on a scale | Standard Deviation 1.14 |
| Compensation Group, Brief Intervention | Change in Clinical Severity From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -3.00 score on a scale | Standard Deviation 1.15 |
| Compensation Group, Full Intervention | Change in Clinical Severity From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -3.33 score on a scale | Standard Deviation 0.58 |
Primary
Change in Clinician-Rated Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Group, Brief Intervention | 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 |
| Standard Group, Full Intervention | Change in Clinician-Rated Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -2.57 score on a scale | Standard Deviation 7.5 |
| Capitalization Group, Brief Intervention | Change in Clinician-Rated Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -8.29 score on a scale | Standard Deviation 8.53 |
| Capitalization Group, Full Intervention | Change in Clinician-Rated Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -8.50 score on a scale | Standard Deviation 7.78 |
| Compensation Group, Brief Intervention | Change in Clinician-Rated Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -6.00 score on a scale | Standard Deviation 4.9 |
| Compensation Group, Full Intervention | Change in Clinician-Rated Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -5.00 score on a scale | Standard Deviation 8.19 |
Primary
Change in Clinician-Rated Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Group, Brief Intervention | 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 |
| Standard Group, Full Intervention | Change in Clinician-Rated Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -.29 score on a scale | Standard Deviation 7.15 |
| Capitalization Group, Brief Intervention | Change in Clinician-Rated Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -6.86 score on a scale | Standard Deviation 8.23 |
| Capitalization Group, Full Intervention | Change in Clinician-Rated Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -1.50 score on a scale | Standard Deviation 3.54 |
| Compensation Group, Brief Intervention | Change in Clinician-Rated Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -3.86 score on a scale | Standard Deviation 5.34 |
| Compensation Group, Full Intervention | Change in Clinician-Rated Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -5.00 score on a scale | Standard Deviation 3.46 |
Primary
Change in Self-Reported Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
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
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Group, Brief Intervention | 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 2.4 |
| Standard Group, Full Intervention | Change in Self-Reported Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -1.57 score on a scale | Standard Error 4.69 |
| Capitalization Group, Brief Intervention | Change in Self-Reported Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -2.00 score on a scale | Standard Error 2.74 |
| Capitalization Group, Full Intervention | Change in Self-Reported Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -2.00 score on a scale | Standard Error 0 |
| Compensation Group, Brief Intervention | Change in Self-Reported Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -3.33 score on a scale | Standard Error 2.66 |
| Compensation Group, Full Intervention | Change in Self-Reported Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -7.50 score on a scale | Standard Error 0.71 |
Primary
Change in Self-Reported Aversive Reactions to Emotions From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
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
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Group, Brief Intervention | 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 |
| Standard Group, Full Intervention | Change in Self-Reported Aversive Reactions to Emotions From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -7.14 score on a scale | Standard Deviation 6.79 |
| Capitalization Group, Brief Intervention | Change in Self-Reported Aversive Reactions to Emotions From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -3.40 score on a scale | Standard Deviation 8.65 |
| Capitalization Group, Full Intervention | Change in Self-Reported Aversive Reactions to Emotions From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -2.00 score on a scale | Standard Deviation 0 |
| Compensation Group, Brief Intervention | Change in Self-Reported Aversive Reactions to Emotions From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -6.83 score on a scale | Standard Deviation 8.15 |
| Compensation Group, Full Intervention | Change in Self-Reported Aversive Reactions to Emotions From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -18.50 score on a scale | Standard Deviation 6.36 |
Primary
Change in Self-Reported Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
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
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Group, Brief Intervention | 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 |
| Standard Group, Full Intervention | Change in Self-Reported Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -1.57 score on a scale | Standard Deviation 6.32 |
| Capitalization Group, Brief Intervention | Change in Self-Reported Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -1.20 score on a scale | Standard Deviation 3.56 |
| Capitalization Group, Full Intervention | Change in Self-Reported Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -4.00 score on a scale | Standard Deviation 0 |
| Compensation Group, Brief Intervention | Change in Self-Reported Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -1.67 score on a scale | Standard Deviation 4.41 |
| Compensation Group, Full Intervention | Change in Self-Reported Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) | -3.00 score on a scale | Standard Deviation 1.41 |