Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive Bias Modification for OCD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03799419
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Martha J Falkenstein, Mclean Hospital

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.


Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Obsessive-compulsive Disorders and Symptoms Behavioral: Cognitive bias modification for interpretation bias Behavioral: Psychoeducation Behavioral: Approach avoidance training Behavioral: Inactive sham approach avoidance training Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cognitive Bias Modification as an Adjunctive Treatment for Treatment-Refractory OCD
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Behavioral: 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.

Sham Comparator: Psychoeducation with treatment as usual
Participants in this group will receive usual treatment in the program and 8 sessions of psychoeducation
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.

Experimental: 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
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).

Sham Comparator: 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
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in Average Score on Yale-Brown Obsessive Compulsive Scale [ Time Frame: Weeks 0, 4, and 8 ]
    Interviewer-rated measure of OCD symptoms. It is 19 items, with only items 1-10 scored (from 0-4). Total scores range from 0-40, with higher scores reflecting greater severity.

  2. Change in Event-related potentials during interpretation bias task [ Time Frame: Weeks 0, 2, and 4 ]
    EEG will be used to assess event-related potentials during an interpretation bias task using a lexical decision paradigm.

  3. Change in Columbia-Suicide Severity Rating Scale [ Time Frame: Weeks 0, 4, and 8 ]
    An interviewer-rated assessment of retrospective suicidality as well as recent suicidal ideation and behavior. Minimum total score 0, maximum total score 5, higher total scores indicate more suicidal ideation and/or behavior.

  4. Change in Suicide Implicit Association Test [ Time Frame: Weeks 0, 2, and 4 ]
    Computerized task which assesses implicit thoughts about self-injury, death, and suicide.

  5. Change in Average Score on Depressive Symptom Index Suicidality Subscale. There are 4 items scored from 0-3 with greater numbers indicating greater severity. [ Time Frame: Weeks 0, 1, 2, 3, and 4 ]
    Self-report measure of suicidality

  6. Credibility/Expectancy Questionnaire [ Time Frame: Week 0 ]
    Measure of treatment expectancy and rationale credibility in our study. The items are rated on 9-point scales, with a total score range of 3 to 27. Greater scores indicate greater expectations and perceptions of treatment credibility.

  7. Exit Interview [ Time Frame: Week 4 ]
    This interview will be conducted by a member of the study staff to obtain participant feedback on satisfaction and how the intervention might be improved.

  8. Change in Behavioral Approach Test [ Time Frame: Weeks 0, 2, and 4 ]

    Behavioral Approach Test (BAT) will be administered as a measure of OCD-related avoidance, based on previously validated procedures (Cougle et al., 2007; Amir, Kuckertz, & Najmi, 2013). Participants rate peak anxiety 0-100 for each step of approaching feared stimuli.

    Three different types of BAT will be implemented in order to measure avoidance with multiple types of contaminants, each with six steps on a hierarchy to be completed sequentially, providing a rating of anxiety 0-100 for each step.


  9. Change in Average Score on Behavioral Inhibition/Behavioral Activation Scales [ Time Frame: Weeks 0, 2, 4, and 8 ]
    24-item measure of behavioral approach and behavioral avoidance, rated 1-4 and summed.

  10. Dimensional Obsessive-Compulsive Scale [ Time Frame: Weeks 0, 2, 4, and 8 ]
    (DOCS; Abramowitz et al., 2010) participants with contamination fears will be identified by their DOCS contamination subscale score; the DOCS is part of the admission measures in the OCD Institute's main study protocol. Additionally, we will examine these scores as an outcome measure for contamination-related obsessions and compulsions. It includes 20 items and is rated 0-4.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) of transcranial magnetic stimulation (TMS)
  • Current symptoms of acute mania or psychosis
  • A reported diagnosis at admission of bipolar disorder, psychotic disorder, or autism spectrum disorder
  • History of traumatic brain injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799419


Contacts
Layout table for location contacts
Contact: Martha Falkenstein 617-855-4424 mfalkenstein@mclean.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Martha Falkenstein    617-855-4424    mfalkenstein@mclean.harvard.edu   
Sponsors and Collaborators
Mclean Hospital

Layout table for additonal information
Responsible Party: Martha J Falkenstein, Staff Psychologist, Mclean Hospital
ClinicalTrials.gov Identifier: NCT03799419     History of Changes
Other Study ID Numbers: 2017P002864
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Martha J Falkenstein, Mclean Hospital:
cognitive bias modification
interpretation bias
approach avoidance

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders