Recruiting

Observational Study

Sponsor:

Mclean Hospital

Code:

NCT05224414

Conditions

Obsessive-Compulsive Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive bias modification for interpretation bias

Psychoeducation

Study Details

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 ID

NCT05224414

Start date

Mar 30, 2022

Status verified date

May, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

106 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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

sham comparator: Psychoeducation with treatment as usual

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

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.

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.

Primary outcome measure

  • Change in Average Score on Yale-Brown Obsessive Compulsive Scale [ Time Frame: Weeks 0, 4, and 8 ]

Central Contacts and Locations

Central contacts

Martha Falkenstein, PhD

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

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

Contacts

Martha Falkenstein

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

More Information

Sponsor

Mclean Hospital

Last update posted

May 18, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2026-05-18.