Interpretation Bias as a Mechanism of Treatment Response in OCD

Not Applicable

Recruiting

• Conditions: Obsessive-Compulsive Disorder

• Registration Number: NCT05224414
• Lead Sponsor: Mclean Hospital

Brief Summary

This study will conduct a randomized controlled trial of Cognitive Bias Modification for Interpretation (CBM-I) as an augmentation to treatment as usual for obsessive compulsive disorder (OCD). CBM-I is a digital intervention designed to directly manipulate interpretation bias through repeated practice on a training task, thereby inducing cognitive changes in a relatively automatic or implicit manner. Specifically, this study will examine the feasibility, acceptability, and clinical outcomes associated with CBM-I.

Adults with obsessive compulsive disorder (OCD) will be recruited from a treatment program for this disorder and participants will be randomly assigned to either receive: 1) up to 12 sessions of CBM-I, or or up to 12 sessions of psychoeducation as a control condition.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-02-04
• Study Start: 2022-03-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• 1. OCD Institute patients
• 2. adults (> 18 years old)
• 3. able to complete a computer task for 20 minutes
• 4. consent to main OCD Institute study protocol
• 5. primary diagnosis of OCD (as measured by a score of >16 on the Y-BOCS and a clinical diagnosis of OCD by their treatment team
• 6. score of >131 on the Obsessive Beliefs Questionnaire-44 at admission [which is 1 SD above the mean score of the non-clinical sample reported in the original validation paper by the Obsessive Compulsive Cognitions Working Group (2005)]

Exclusion Criteria

• 1. Currently experiencing acute symptoms of psychosis
• 2. Psychotic disorder diagnosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Average Score on Yale-Brown Obsessive Compulsive Scale	Weeks 0, 4, and 8	Interviewer-rated measure of OCD symptoms. It is 19 items, with only items 1-10 scored (from 0-4). Total scores range from 0-40, with higher scores reflecting greater severity.

Secondary Outcome Measures

Name	Time	Method
Change in Average Score on Obsessive Beliefs Questionnaire	Time Frame: Weeks 0, 2, 4, and 8	Measure of interpretation biases, specifically: Inflated Responsibility/Overestimation of Threat, Perfectionism/Intolerance of Uncertainty, and Importance/Control of Thoughts. 44-item self-report measure, items scored 1-7 and summed; greater scores indicate greater severity.

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States