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Cognitive Bias Modification for OCD

Primary Purpose

Obsessive-Compulsive Disorder, Obsessive-compulsive Disorders and Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive bias modification for interpretation bias
Psychoeducation
Approach avoidance training
Inactive sham approach avoidance training
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obsessive-Compulsive Disorder focused on measuring cognitive bias modification, interpretation bias, approach avoidance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McLean HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

Cognitive bias modification with treatment as usual

Psychoeducation with treatment as usual

Approach avoidance training with treatment as usual

Inactive sham approach avoidance training

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Average Score on Yale-Brown Obsessive Compulsive Scale
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.
Change in Columbia-Suicide Severity Rating Scale
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.
Change in Suicide Implicit Association Test
Computerized task which assesses implicit thoughts about self-injury, death, and suicide.
Change in Average Score on Depressive Symptom Index Suicidality Subscale. There are 4 items scored from 0-3 with greater numbers indicating greater severity.
Self-report measure of suicidality
Credibility/Expectancy Questionnaire
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.
Exit Interview
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.
Change in Behavioral Approach Test
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.
Change in Average Score on Behavioral Inhibition/Behavioral Activation Scales
24-item measure of behavioral approach and behavioral avoidance, rated 1-4 and summed.
Dimensional Obsessive-Compulsive Scale
(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.

Full Information

First Posted
January 2, 2019
Last Updated
March 14, 2023
Sponsor
Mclean Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03799419
Brief Title
Cognitive Bias Modification for OCD
Official Title
Cognitive Bias Modification as an Adjunctive Treatment for Treatment-Refractory OCD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder, Obsessive-compulsive Disorders and Symptoms
Keywords
cognitive bias modification, interpretation bias, approach avoidance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive bias modification with treatment as usual
Arm Type
Experimental
Arm Description
Participants in this group will receive usual treatment in the program and 8 sessions of a computerized cognitive training targeting interpretation bias
Arm Title
Psychoeducation with treatment as usual
Arm Type
Sham Comparator
Arm Description
Participants in this group will receive usual treatment in the program and 8 sessions of psychoeducation
Arm Title
Approach avoidance training with treatment as usual
Arm Type
Experimental
Arm Description
Participants in this group will receive usual treatment in the program and 8 sessions of a computerized cognitive training targeting automatic approach tendencies
Arm Title
Inactive sham approach avoidance training
Arm Type
Sham Comparator
Arm Description
Participants in this group will receive usual treatment in the program and 8 sessions of a sham approach avoidance training
Intervention Type
Behavioral
Intervention Name(s)
Cognitive bias modification for interpretation bias
Intervention Description
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
Intervention Name(s)
Psychoeducation
Intervention Description
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
Intervention Name(s)
Approach avoidance training
Intervention Description
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
Intervention Name(s)
Inactive sham approach avoidance training
Intervention Description
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 Measure Information:
Title
Change in Average Score on Obsessive Beliefs Questionnaire
Description
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.
Time Frame
Weeks 0, 2, 4, and 8
Secondary Outcome Measure Information:
Title
Change in Average Score on Yale-Brown Obsessive Compulsive Scale
Description
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.
Time Frame
Weeks 0, 4, and 8
Title
Change in Columbia-Suicide Severity Rating Scale
Description
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.
Time Frame
Weeks 0, 4, and 8
Title
Change in Suicide Implicit Association Test
Description
Computerized task which assesses implicit thoughts about self-injury, death, and suicide.
Time Frame
Weeks 0, 2, and 4
Title
Change in Average Score on Depressive Symptom Index Suicidality Subscale. There are 4 items scored from 0-3 with greater numbers indicating greater severity.
Description
Self-report measure of suicidality
Time Frame
Weeks 0, 1, 2, 3, and 4
Title
Credibility/Expectancy Questionnaire
Description
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.
Time Frame
Week 0
Title
Exit Interview
Description
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.
Time Frame
Week 4
Title
Change in Behavioral Approach Test
Description
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.
Time Frame
Weeks 0, 2, and 4
Title
Change in Average Score on Behavioral Inhibition/Behavioral Activation Scales
Description
24-item measure of behavioral approach and behavioral avoidance, rated 1-4 and summed.
Time Frame
Weeks 0, 2, 4, and 8
Title
Dimensional Obsessive-Compulsive Scale
Description
(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.
Time Frame
Weeks 0, 2, 4, and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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) Current symptoms of acute mania or psychosis A reported diagnosis at admission of a psychotic disorder History of traumatic brain injury
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martha Falkenstein
Phone
617-855-4424
Email
mfalkenstein@mclean.harvard.edu
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha Falkenstein
Phone
617-855-4424
Email
mfalkenstein@mclean.harvard.edu

12. IPD Sharing Statement

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Cognitive Bias Modification for OCD

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