Obsessive-Compulsive Disorder Clinical Trial
Official title:
Cognitive Bias Modification as an Adjunctive Treatment for Treatment-Refractory OCD
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | McLean Hospital | Belmont | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Mclean Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Weeks 0, 4, and 8 | |
Secondary | 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. | Weeks 0, 4, and 8 | |
Secondary | Change in Suicide Implicit Association Test | Computerized task which assesses implicit thoughts about self-injury, death, and suicide. | Weeks 0, 2, and 4 | |
Secondary | 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 | Weeks 0, 1, 2, 3, and 4 | |
Secondary | 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. | Week 0 | |
Secondary | 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. | Week 4 | |
Secondary | 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. |
Weeks 0, 2, and 4 | |
Secondary | Change in Average Score on Behavioral Inhibition/Behavioral Activation Scales | 24-item measure of behavioral approach and behavioral avoidance, rated 1-4 and summed. | Weeks 0, 2, 4, and 8 | |
Secondary | 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. | Weeks 0, 2, 4, and 8 |
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