Obsessive-Compulsive Disorder
Conditions
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.
Interventions
DEVICEMindfulness
Clients will use a consumer grade EEG device that provides guided mindfulness home practices
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Yale-Brown Obsessive Compulsive Scale (YBOCS) | Completed once per week, for eight weeks | A self-report inventory of obsessive compulsive symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Obsessive Beliefs Questionnaire | Completed at three timepoints - week 1, week 4, week 8 | Self-report measure of OCD beliefs |
| Five Factor Mindfulness Questionnaire | Completed at three timepoints - week 1, week 4, week 8 | Self-report measure of mindfulness |
| Thought Control Questionnaire | Completed at three timepoints - week 1, week 4, week 8 | Self-report measure of use of thought control strategies |
| Obsessive Compulsive Inventory | Completed at three timepoints - week 1, week 4, week 8 | Self-report measure of obsessive compulsive symptoms |
| Mind Wandering Scale | Completed at three timepoints - week 1, week 4, week 8 | Self-report measure of mind wandering |
| Metacognitions Questionnaire | Completed at three timepoints - week 1, week 4, week 8 | Self-report measure of metacognitive strategies |
| Acceptance and Action Questionnaire | Completed at three timepoints - week 1, week 4, week 8 | Self-report measure of experiential avoidance |
Countries
Canada
Outcome results
None listed