NCT03799419|Completed
Cognitive Bias Modification for OCD
Cognitive Bias Modification as an Adjunctive Treatment for Treatment-Refractory OCD
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Cognitive Bias Modification as an Adjunctive Treatment for Treatment-Refractory OCD
Sponsor study identifier
interventional
64
1 country
1
Study Start
April 1, 2019
Actual (reported)Primary Completion
July 23, 2024
Actual (reported)Study Completion
July 23, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 23, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2, 2019
Actual (reported)January 10, 2019
Actual (reported)April 1, 2019
Actual (reported)July 23, 2024
Actual (reported)July 23, 2024
Actual (reported)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
Change in Average Score on Yale-Brown Obsessive Compulsive Scale
Weeks 0, 4, and 8
Change in Columbia-Suicide Severity Rating Scale
Weeks 0, 4, and 8
Change in Suicide Implicit Association Test
Weeks 0, 2, and 4
Change in Average Score on Depressive Symptom Index Suicidality Subscale. There are 4 items scored from 0-3 with greater numbers indicating greater severity.
Weeks 0, 1, 2, 3, and 4
Credibility/Expectancy Questionnaire
Week 0
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
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.
McLean Hospital
Belmont, Massachusetts, 02478, United States
64 participants (actual enrollment reported by the registry).
First Submitted
January 2, 2019
First Posted
January 10, 2019
Study Start
April 1, 2019
Actual (reported)Waitlist-Control Trial of Smartphone CBT for Obsessive-Compulsive Disorder (OCD)
Development of Adaptive Deep Brain Stimulation for OCD
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
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.
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).
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 23, 2024
Actual (reported)Study Completion
July 23, 2024
Actual (reported)Last Updated
July 24, 2024
Record last verified: 2024-07
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Source: ClinicalTrials.gov.
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