Mindfulness Meditation Utilizing an EEG Biofeedback Device for the Treatment for Obsessive Compulsive Disorder

Evaluating the Use of Mindfulness Meditation Utilizing a Consumer-Grade EEG Biofeedback Device for Patients Awaiting Treatment for Obsessive Compulsive Disorder

Sponsors

Lead Sponsor: Sunnybrook Health Sciences Centre

Source Sunnybrook Health Sciences Centre
Brief Summary

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.

Detailed Description

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.

Overall Status Completed
Start Date 2017-04-10
Completion Date 2019-01-31
Primary Completion Date 2019-01-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Yale-Brown Obsessive Compulsive Scale (YBOCS) Completed once per week, for eight weeks
Secondary Outcome
Measure Time Frame
Obsessive Compulsive Inventory Completed at three timepoints - week 1, week 4, week 8
Obsessive Beliefs Questionnaire Completed at three timepoints - week 1, week 4, week 8
Five Factor Mindfulness Questionnaire Completed at three timepoints - week 1, week 4, week 8
Thought Control Questionnaire Completed at three timepoints - week 1, week 4, week 8
Acceptance and Action Questionnaire Completed at three timepoints - week 1, week 4, week 8
Mind Wandering Scale Completed at three timepoints - week 1, week 4, week 8
Metacognitions Questionnaire Completed at three timepoints - week 1, week 4, week 8
Enrollment 71
Condition
Intervention

Intervention Type: Device

Intervention Name: Mindfulness

Description: Clients will use a consumer grade EEG device that provides guided mindfulness home practices

Arm Group Label: Mindfulness

Eligibility

Criteria:

Inclusion Criteria: - All inclusion and exclusion criteria are consistent with the established guidelines for our service - there are no additional study specific criteria. Potential subjects are referred to the service with a query of OCD. Due to the nature of the assessment procedures, which include English-language self-report questionnaires and scales, the ability to communicate in written and spoken English is an inclusion criterion. disorder Exclusion Criteria: - Exclusion criteria include a) those with active substance abuse/dependence, b) suspected organic pathology, c) recent suicide attempt/active suicidality, d) active bipolar, psychotic disorder or post-traumatic stress

Gender:

All

Minimum Age:

18 Years

Maximum Age:

60 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Peggy Richter, M.D. Study Director Sunnybrook Health Sciences Centre
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Sunnybrook Health Sciences Centre
Location Countries

Canada

Verification Date

2019-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Mindfulness

Type: Experimental

Description: 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

Label: Control

Type: No Intervention

Description: 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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: A repeated measures multivariate analysis of variance (MANOVA) will be conducted with the two groups (guided mindfulness meditation or control wait list group) as the between-group variable and OCD symptom scores as the dependent variables. A mediation analysis will examine whether obsessive beliefs, engagement in thought control strategies, psychological flexibility, and mind wandering mediates treatment related changes in OCD symptom scores (YBOCS, OCI). Daily practice data from the EEG headsets will be automatically uploaded to an encrypted server. These data will be made anonymous from the start of the study; subjects will be identified using their subject I.D. EEG data will be preprocessed and analyzed using EEG Lab (Delorme & Makeig, 2004).

Primary Purpose: Treatment

Masking: None (Open Label)

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