Interpretation Bias as a Mechanism of Treatment Response in OCD

Mass General Brigham

Status: Enrolling

Conditions: Obsessive-Compulsive Disorder

Treatments: Behavioral: Psychoeducation; Behavioral: Cognitive bias modification for interpretation bias

Study type: Interventional

Funder types: Other

Identifiers

NCT05224414

2022P000190

Details and patient eligibility

About

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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups

Cognitive bias modification with treatment as usual

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive bias modification for interpretation bias

Psychoeducation with treatment as usual

Sham Comparator group

Description:

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

Treatment:

Behavioral: Psychoeducation