Cognitive Bias Modification for OCD

NCT ID: NCT03799419

Last Updated: 2024-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2024-07-23

Brief Summary

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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.

Detailed Description

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Conditions

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Obsessive-Compulsive Disorder Obsessive-compulsive Disorders and Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cognitive bias modification with treatment as usual

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

Group Type EXPERIMENTAL

Cognitive bias modification for interpretation bias

Intervention Type 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.

Psychoeducation with treatment as usual

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

Group Type SHAM_COMPARATOR

Psychoeducation

Intervention Type 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.

Approach avoidance training with treatment as usual

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

Group Type EXPERIMENTAL

Approach avoidance training

Intervention Type 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).

Inactive sham approach avoidance training

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

Group Type SHAM_COMPARATOR

Inactive sham approach avoidance training

Intervention Type 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.

Interventions

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Cognitive bias modification for interpretation bias

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.

Intervention Type BEHAVIORAL

Psychoeducation

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.

Intervention Type BEHAVIORAL

Approach avoidance training

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).

Intervention Type BEHAVIORAL

Inactive sham approach avoidance training

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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Martha J Falkenstein

Staff Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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McLean Hospital

Belmont, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2017P002864

Identifier Type: -

Identifier Source: org_study_id

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