Mindfulness Meditation Utilizing an EEG Biofeedback Device for the Treatment for Obsessive Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

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.
    

Intervention name(s): Mindfulness
Intervention type(s): Device
Intervention description(s): Clients will use a consumer grade EEG device that provides guided mindfulness home practices
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).
Masking: None (Open Label)
Primary purpose: Treatment