Increasing Treatment Efficacy Using SMART Methods for Personalizing Care

Not Applicable

Completed

Conditions: Anxiety Disorders
Post Traumatic Stress Disorder
Obsessive-Compulsive Disorder

Registration Number: NCT04642898

Lead Sponsor: Shannon E. Sauer-Zavala

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 61

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
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 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.