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N/A Completed N=61 Randomized Double-blind Treatment

Increasing Treatment Efficacy Using SMART Methods for Personalizing Care

Source: ClinicalTrials.gov NCT04642898 ↗
Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: Change in Clinical Severity From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) — -2.40; -2.86; -2.71; -2.00 score on a scale

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Clinical Severity From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
-2.40; -2.86; -2.71; -2.00; -3.00; -3.33
PRIMARY
Change in Self-Reported Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
-2.56; -1.57; -2.00; -2.00; -3.33; -7.50
PRIMARY
Change in Self-Reported Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
0; -1.57; -1.20; -4.00; -1.67; -3.00
PRIMARY
Change in Self-Reported Aversive Reactions to Emotions From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
-4.44; -7.14; -3.40; -2.00; -6.83; -18.50
PRIMARY
Change in Clinician-Rated Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
-3.6; -2.57; -8.29; -8.50; -6.00; -5.00
PRIMARY
Change in Clinician-Rated Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
-1.22; -.29; -6.86; -1.50; -3.86; -5.00

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04642898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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