Interpretation Bias as a Mechanism of Treatment Response in OCD

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Interpretation Bias as a Mechanism of Treatment Response in OCD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05224414
• Other study ID #: 2022P000190
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2022
• Est. completion date: August 31, 2026

Study information

• Verified date: March 2024
• Source: Mclean Hospital
• Contact: Martha Falkenstein, PhD
• Phone: 617-855-4424
• Email: mfalkenstein[@]mclean.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Average Score on Obsessive Beliefs Questionnaire	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.	Time Frame: Weeks 0, 2, 4, and 8