Interpretation Bias as a Mechanism of Treatment Response in OCD

NCT ID: NCT05224414

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-30
• Study Completion Date: 2026-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Cognitive bias modification with treatment as usual

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

Group Type: EXPERIMENTAL

Cognitive bias modification for interpretation bias

Intervention Type: 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.

Psychoeducation with treatment as usual

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

Group Type: SHAM_COMPARATOR

Psychoeducation

Intervention Type: 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.

Interventions

Cognitive bias modification for interpretation bias

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.

Intervention Type: BEHAVIORAL

Psychoeducation

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Martha J Falkenstein

Director of Research, OCD Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

McLean Hospital

Belmont, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Martha Falkenstein, PhD

Role: CONTACT

mfalkenstein@mclean.harvard.edu

617-855-4424

Facility Contacts

Martha Falkenstein

Role: primary

mfalkenstein@mclean.harvard.edu

617-855-4424

Other Identifiers

2022P000190

Identifier Type: -

Identifier Source: org_study_id