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Clinical Trials/NCT05224414
NCT05224414
Recruiting
Not Applicable

Interpretation Bias as a Mechanism of Treatment Response in OCD

Mclean Hospital1 site in 1 country106 target enrollmentMarch 30, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obsessive-Compulsive Disorder
Sponsor
Mclean Hospital
Enrollment
106
Locations
1
Primary Endpoint
Change in Average Score on Yale-Brown Obsessive Compulsive Scale
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 30, 2022
End Date
August 31, 2026
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Martha J Falkenstein

Director of Research, OCD Institute

Mclean Hospital

Eligibility Criteria

Inclusion Criteria

  • 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 \[which is 1 SD above the mean score of the non-clinical sample reported in the original validation paper by the Obsessive Compulsive Cognitions Working Group (2005)\]

Exclusion Criteria

  • Currently experiencing acute symptoms of psychosis
  • Psychotic disorder diagnosis

Outcomes

Primary Outcomes

Change in Average Score on Yale-Brown Obsessive Compulsive Scale

Time Frame: 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 Outcomes

  • Change in Average Score on Obsessive Beliefs Questionnaire(Time Frame: Weeks 0, 2, 4, and 8)

Study Sites (1)

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