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Cognitive Bias Modification for Obsessive-Compulsive Disorder

N/A

Recruiting

Research Sponsored by Mclean Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults (> 18 years old)

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)

Must not have

Psychotic disorder diagnosis

Currently experiencing acute symptoms of psychosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time frame: weeks 0, 2, 4, and 8

Summary

This trial will test whether CBM-I is a feasible and acceptable augmentation to treatment as usual for OCD, and will examine preliminary efficacy by examining clinical outcomes associated with CBM-I.

Who is the study for?

This trial is for adults over 18 with a primary diagnosis of OCD, confirmed by specific clinical assessments. Participants must be able to complete computer tasks and consent to the main study protocol. Those with acute psychosis or a psychotic disorder cannot join.

What is being tested?

The trial tests Cognitive Bias Modification for Interpretation (CBM-I), a digital intervention aimed at changing interpretation bias in OCD patients, against psychoeducation. It will assess CBM-I's feasibility, acceptability, and impact on OCD when added to usual treatment.

What are the potential side effects?

Since CBM-I involves computer-based tasks and psychoeducation is informational, significant side effects are not anticipated. However, participants may experience discomfort or fatigue from focusing on a screen during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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I have been diagnosed with OCD and my symptoms are moderate to severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a psychotic disorder.

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I am currently experiencing severe symptoms of psychosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame: weeks 0, 2, 4, and 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame: weeks 0, 2, 4, and 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: weeks 0, 2, 4, and 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Average Score on Yale-Brown Obsessive Compulsive Scale

Secondary study objectives

Change in Average Score on Obsessive Beliefs Questionnaire

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Cognitive bias modification with treatment as usualExperimental Treatment1 Intervention

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

Group II: Psychoeducation with treatment as usualPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive bias modification for interpretation bias

2019

N/A

~70

0 / 4Eligibility criteria met