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Clinical Trials/NCT03799419
NCT03799419
Completed
Not Applicable

Cognitive Bias Modification as an Adjunctive Treatment for Treatment-Refractory OCD

Mclean Hospital1 site in 1 country64 target enrollmentApril 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obsessive-Compulsive Disorder
Sponsor
Mclean Hospital
Enrollment
64
Locations
1
Primary Endpoint
Change in Average Score on Obsessive Beliefs Questionnaire
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study will conduct the development and preliminary evaluation of Cognitive Bias Modification for Interpretation (CBM-I) and Approach Avoidance Training (AAT) as augmentations to treatment as usual for OCD and related disorders. CBM-I refers to computerized interventions designed to directly manipulate interpretation bias through repeated practice on a training task, thereby inducing cognitive changes in a relatively automatic or implicit manner. In AAT, automatic approach tendencies toward feared stimuli are re-trained. Specifically, this study will examine the feasibility, acceptability, and clinical outcomes associated with CBM-I and AAT.

Adults with obsessive compulsive disorder (OCD) and related disorders will be recruited from a treatment program for these disorders and participants will be randomly assigned to either receive: 1) eight sessions of CBM-I or eight sessions of psychoeducation as a control condition, or 2) AAT or eight sessions of an inactive (sham) version of the AAT training.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
July 23, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Martha J Falkenstein

Staff Psychologist

Mclean Hospital

Eligibility Criteria

Inclusion Criteria

  • Currently receiving treatment at the McLean Hospital OCD Institute
  • For CBM-I condition only: report a score of at least 131 on the Obsessive Beliefs Questionnaire-44 upon admission to the OCD Institute
  • For AAT condition only: endorse score of at least 7 on the DOCS subscale #1 (contamination subscale) upon admission to the OCD Institute
  • Able to complete a computer task for 20 minutes
  • Consent to main OCD Institute study protocol

Exclusion Criteria

  • Currently undergoing electroconvulsive therapy (ECT)
  • Current symptoms of acute mania or psychosis
  • A reported diagnosis at admission of a psychotic disorder
  • History of traumatic brain injury

Outcomes

Primary Outcomes

Change in Average Score on Obsessive Beliefs Questionnaire

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

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.

Secondary Outcomes

  • Change in Average Score on Yale-Brown Obsessive Compulsive Scale(Weeks 0, 4, and 8)
  • Exit Interview(Week 4)
  • Change in Average Score on Behavioral Inhibition/Behavioral Activation Scales(Weeks 0, 2, 4, and 8)
  • Dimensional Obsessive-Compulsive Scale(Weeks 0, 2, 4, and 8)
  • Change in Suicide Implicit Association Test(Weeks 0, 2, and 4)
  • Change in Columbia-Suicide Severity Rating Scale(Weeks 0, 4, and 8)
  • Change in Behavioral Approach Test(Weeks 0, 2, and 4)
  • Change in Average Score on Depressive Symptom Index Suicidality Subscale. There are 4 items scored from 0-3 with greater numbers indicating greater severity.(Weeks 0, 1, 2, 3, and 4)
  • Credibility/Expectancy Questionnaire(Week 0)

Study Sites (1)

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