Cognitive Bias Modification for OCD

NCT03799419 | Completed

• 1 other identifier: 2017P002864
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder; Obsessive-compulsive Disorders and Symptoms

Keywords

cognitive bias modification; interpretation bias; approach avoidance

Outcome Measures

Primary Outcomes (1)

• 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.

  Weeks 0, 2, 4, and 8

Secondary Outcomes (9)

• Change in Average Score on Yale-Brown Obsessive Compulsive Scale

  Weeks 0, 4, and 8

• Change in Columbia-Suicide Severity Rating Scale

  Weeks 0, 4, and 8

• Change in Suicide Implicit Association 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 Arms (4)

Cognitive bias modification with treatment as usual

EXPERIMENTAL

Participants in this group will receive usual treatment in the program and 8 sessions of a computerized cognitive training targeting interpretation bias

Behavioral: Cognitive bias modification for interpretation bias

Psychoeducation with treatment as usual

SHAM COMPARATOR

Participants in this group will receive usual treatment in the program and 8 sessions of psychoeducation

Behavioral: Psychoeducation

Approach avoidance training with treatment as usual

EXPERIMENTAL

Participants in this group will receive usual treatment in the program and 8 sessions of a computerized cognitive training targeting automatic approach tendencies

Behavioral: Approach avoidance training

Inactive sham approach avoidance training

SHAM COMPARATOR

Participants in this group will receive usual treatment in the program and 8 sessions of a sham approach avoidance training

Behavioral: Inactive sham approach avoidance training

Interventions

Cognitive bias modification for interpretation bias BEHAVIORAL

Eight 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.

Cognitive bias modification with treatment as usual

Psychoeducation BEHAVIORAL

Eight 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.

Psychoeducation with treatment as usual

Approach avoidance training BEHAVIORAL

Eight sessions of this computerized training program will be used to train approach tendencies, following previously validated procedures (Najmi, Kuckertz, \& Amir, 2010). During the training program, participants will view a series of these images and be prompted to push or pull a joystick according to prompts on the screen, instead of the content of the picture. Avoidance will be stimulated through both pushing away (images on the screen will decrease in size upon the joystick being pushed), and approach will be stimulated through pulling towards pictures (images will increase in size to simulate approach).

Approach avoidance training with treatment as usual

Inactive sham approach avoidance training BEHAVIORAL

Eight sessions of the approach avoidance training will be administered, however the percentage of push vs pull trials will be altered in this sham version of the training.

Inactive sham approach avoidance training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychologist

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 10, 2019
• Study Start: April 1, 2019
• Primary Completion: July 23, 2024
• Study Completion: July 23, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

US (1)