18 and older, any sex, with Anxiety Disorders or Post Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Clinical Severity From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)Primary· 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.
Group
Value
95% CI
Standard Group, Brief Intervention
-2.40
± 1.26
Standard Group, Full Intervention
-2.86
± 1.46
Capitalization Group, Brief Intervention
-2.71
± 1.25
Capitalization Group, Full Intervention
-2.00
± 1.14
Compensation Group, Brief Intervention
-3.00
± 1.15
Compensation Group, Full Intervention
-3.33
± .58
Change in Self-Reported Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)Primary· 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
Group
Value
95% CI
Standard Group, Brief Intervention
-2.56
± 2.40
Standard Group, Full Intervention
-1.57
± 4.69
Capitalization Group, Brief Intervention
-2.00
± 2.74
Capitalization Group, Full Intervention
-2.00
± 0
Compensation Group, Brief Intervention
-3.33
± 2.66
Compensation Group, Full Intervention
-7.50
± .71
Change in Self-Reported Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)Primary· 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
Group
Value
95% CI
Standard Group, Brief Intervention
0
± 4.58
Standard Group, Full Intervention
-1.57
± 6.32
Capitalization Group, Brief Intervention
-1.20
± 3.56
Capitalization Group, Full Intervention
-4.00
± 0
Compensation Group, Brief Intervention
-1.67
± 4.41
Compensation Group, Full Intervention
-3.00
± 1.41
Change in Self-Reported Aversive Reactions to Emotions From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)Primary· 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
Group
Value
95% CI
Standard Group, Brief Intervention
-4.44
± 9.54
Standard Group, Full Intervention
-7.14
± 6.79
Capitalization Group, Brief Intervention
-3.40
± 8.65
Capitalization Group, Full Intervention
-2.00
± 0
Compensation Group, Brief Intervention
-6.83
± 8.15
Compensation Group, Full Intervention
-18.50
± 6.36
Change in Clinician-Rated Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)Primary· 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.
Group
Value
95% CI
Standard Group, Brief Intervention
-3.6
± 6.99
Standard Group, Full Intervention
-2.57
± 7.5
Capitalization Group, Brief Intervention
-8.29
± 8.53
Capitalization Group, Full Intervention
-8.50
± 7.78
Compensation Group, Brief Intervention
-6.00
± 4.90
Compensation Group, Full Intervention
-5.00
± 8.19
Change in Clinician-Rated Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)Primary· 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.
Group
Value
95% CI
Standard Group, Brief Intervention
-1.22
± 3.77
Standard Group, Full Intervention
-.29
± 7.15
Capitalization Group, Brief Intervention
-6.86
± 8.23
Capitalization Group, Full Intervention
-1.50
± 3.54
Compensation Group, Brief Intervention
-3.86
± 5.34
Compensation Group, Full Intervention
-5.00
± 3.46
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Shannon E. Sauer-Zavala
Last refreshed: 30 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04642898.