Interpretation Bias as a Mechanism of Treatment Response in OCD

NCT05224414 | Recruiting

• 1 other identifier: 2022P000190
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Average Score on Yale-Brown Obsessive Compulsive Scale

  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.

  Weeks 0, 4, and 8

Secondary Outcomes (1)

• Change in Average Score on Obsessive Beliefs Questionnaire

  Time Frame: Weeks 0, 2, 4, and 8

Study Arms (2)

Cognitive bias modification with treatment as usual

EXPERIMENTAL

Participants in this group will receive usual treatment in the program up to 12 sessions of a digital cognitive training targeting interpretation bias

Behavioral: Cognitive bias modification for interpretation bias

Psychoeducation with treatment as usual

SHAM COMPARATOR

Participants in this group will receive usual treatment in the program up to 12 sessions of digitized psychoeducation

Behavioral: Psychoeducation

Interventions

Cognitive bias modification for interpretation bias BEHAVIORAL

Sessions of scenario-based CBM-I training for OCD will be administered, based on the widely-used paradigm of ambiguous scenario training developed by Mathews and Mackintosh (2000), in which participants are presented with scenarios that are ambiguous in whether or not they are threatening. Participants will complete a computer task consisting of a series of written scenarios designed to improve interpretation and attributional biases; these scenarios conclude with word fragments, which participants must fill in to resolve the ambiguity.

Cognitive bias modification with treatment as usual

Psychoeducation BEHAVIORAL

Sessions of psychoeducation will be administered, which will describe symptoms of anxiety, the nature of biased thinking in anxiety, and summarize common psychosocial as well as pharmacological treatments for anxiety. The sessions will provide relevant information but will not provide training in changing thinking styles.

Psychoeducation with treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) OCD Institute patients
• \) adults (\> 18 years old)
• \) able to complete a computer task for 20 minutes
• \) consent to main OCD Institute study protocol
• \) 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
• \) score of \>131 on the Obsessive Beliefs Questionnaire-44 at admission \[which is 1 SD above the mean score of the non-clinical sample reported in the original validation paper by the Obsessive Compulsive Cognitions Working Group (2005)\]

You may not qualify if:

• \) Currently experiencing acute symptoms of psychosis
• \) Psychotic disorder diagnosis

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

Martha Falkenstein, PhD

CONTACT

617-855-4424; mfalkenstein@mclean.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, OCD Institute

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 4, 2022
• Study Start: March 30, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

US (1)