Interpretation Bias as a Mechanism of Treatment Response in OCD

Not Applicable

Recruiting

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Behavioral: Cognitive bias modification for interpretation bias; Behavioral: Psychoeducation

• 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

Arm && Interventions

Group	Intervention	Description
Cognitive bias modification with treatment as usual	Cognitive bias modification for interpretation bias	Participants in this group will receive usual treatment in the program up to 12 sessions of a digital cognitive training targeting interpretation bias
Psychoeducation with treatment as usual	Psychoeducation	Participants in this group will receive usual treatment in the program up to 12 sessions of digitized psychoeducation

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