An interventional study of Mindfulness in Obsessive-Compulsive Disorder, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-10.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment
The Frederick W. Thompson Anxiety Disorders Centre has experienced significant demand for services related to the treatment of Obsessive Compulsive Disorder (OCD), resulting in a significant wait time for service. Although Cognitive Behavior Therapy (CBT) is the most efficacious treatment intervention for OCD, there is a growing literature indicating the mindfulness based approaches can be beneficial in terms of managing acute mood and anxiety symptoms as well as reducing relapse risk following treatment.The goal of this study is to examine the potential benefits of using a consumer grade EEG-based biofeedback device that allows clients to engage in home based mindfulness meditation practices while they are waiting to receive clinical services. Specifically, this study will investigate the effects of meditation home practice on symptom alleviation, as related to specific OCD related cognitive processes.
The goal of this study is to examine the potential benefits of using a consumer grade EEG-based biofeedback device that allows clients to engage in home based mindfulness meditation practices while they are waiting to receive clinical services. Specifically, this study will investigate the effects of meditation home practice on symptom alleviation, as related to specific OCD related cognitive processes.The study will be a randomized trial where subjects (N=100) will be randomly assigned to receive either 1) an eight week meditation program involving use of an EEG-based biofeedback device, or 2) wait list as per usual. The experimental design is a 2 (treatment condition: Group 1: Mindfulness, Group 2: Control) by 3 (assessment phase: baseline (week 0), mid-treatment (week 4), post-treatment (week 8)) repeated measures factorial design. Group randomization will be completed by the principal investigator, using the "GraphPad Quick Calcs" online calculator which offers simple random allocation into equal-sized groups.Outcome measures will involve ratings of OCD symptom severity, OCD beliefs, mindfulness, and use of thought control strategies. At baseline, mid treatment (session 4), and post intervention, participants will complete the Yale-Brown Obsessive Compulsive Scale, Obsessive Compulsive Inventory, Obsessive Beliefs Questionnaire, Five Factor Mindfulness Questionnaire, Thought Control Questionnaire, Acceptance and Action Questionnaire, Mind Wandering Scale and the Metacognitions Questionnaire. Once per week, participants will complete the YBOCS, TCQ, and MW. This weekly data will be collected online using the "Survey Monkey" web portal. Daily practice data from the EEG headsets will be automatically uploaded to an encrypted server.
Exclusion Criteria:
The study will be a randomized trial where subjects (N=100) will be randomly assigned to receive either 1) an eight week meditation program involving use of an EEG-based biofeedback device, or 2) wait list as per usual. The experimental design is a 2 (treatment condition: Group 1: Mindfulness, Group 2: Control) by 3 (assessment phase: baseline (week 0), mid-treatment (week 4), post-treatment (week 8)) repeated measures factorial design. Group randomization will be completed by the principal investigator, using the "GraphPad Quick Calcs" online calculator which offers simple random allocation into equal-sized groups
Device: Mindfulness
The study will be a randomized trial where subjects (N=100) will be randomly assigned to receive either 1) an eight week meditation program involving use of an EEG-based biofeedback device, or 2) wait list as per usual. The experimental design is a 2 (treatment condition: Group 1: Mindfulness, Group 2: Control) by 3 (assessment phase: baseline (week 0), mid-treatment (week 4), post-treatment (week 8)) repeated measures factorial design. Group randomization will be completed by the principal investigator, using the "GraphPad Quick Calcs" online calculator which offers simple random allocation into equal-sized groups
Clients will use a consumer grade EEG device that provides guided mindfulness home practices
Yale-Brown Obsessive Compulsive Scale (YBOCS)
A self-report inventory of obsessive compulsive symptoms
Time frame: Completed once per week, for eight weeks
Obsessive Compulsive Inventory
Self-report measure of obsessive compulsive symptoms
Time frame: Completed at three timepoints - week 1, week 4, week 8
Obsessive Beliefs Questionnaire
Self-report measure of OCD beliefs
Time frame: Completed at three timepoints - week 1, week 4, week 8
Five Factor Mindfulness Questionnaire
Self-report measure of mindfulness
Time frame: Completed at three timepoints - week 1, week 4, week 8
Thought Control Questionnaire
Self-report measure of use of thought control strategies
Time frame: Completed at three timepoints - week 1, week 4, week 8
Acceptance and Action Questionnaire
Self-report measure of experiential avoidance
Time frame: Completed at three timepoints - week 1, week 4, week 8
Mind Wandering Scale
Self-report measure of mind wandering
Time frame: Completed at three timepoints - week 1, week 4, week 8
Metacognitions Questionnaire
Self-report measure of metacognitive strategies
Time frame: Completed at three timepoints - week 1, week 4, week 8
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Compulsive Personality Disorder→
Sunnybrook Health Sciences Centre