Interpretation Bias as a Mechanism of Treatment Response in OCD
Primary Purpose
Obsessive-Compulsive Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive bias modification for interpretation bias
Psychoeducation
Sponsored by
About this trial
This is an interventional basic science trial for Obsessive-Compulsive Disorder
Eligibility Criteria
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
Sites / Locations
- McLean HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Cognitive bias modification with treatment as usual
Psychoeducation with treatment as usual
Arm Description
Participants in this group will receive usual treatment in the program up to 12 sessions of a digital cognitive training targeting interpretation bias
Participants in this group will receive usual treatment in the program up to 12 sessions of digitized psychoeducation
Outcomes
Primary 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.
Secondary 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05224414
Brief Title
Interpretation Bias as a Mechanism of Treatment Response in OCD
Official Title
Interpretation Bias as a Mechanism of Treatment Response in OCD
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
106 (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 up to 12 sessions of a digital 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 up to 12 sessions of digitized psychoeducation
Intervention Type
Behavioral
Intervention Name(s)
Cognitive bias modification for interpretation bias
Intervention Description
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
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.
Primary 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
Secondary 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
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martha Falkenstein, PhD
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
Learn more about this trial
Interpretation Bias as a Mechanism of Treatment Response in OCD
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