Cognitive Bias Modification for OCD
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|ClinicalTrials.gov Identifier: NCT03799419|
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : May 7, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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|
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
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799419
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|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
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