Randomized Controlled Meditation Trial for Treating OCD

Study Overview
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Brief Summary
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The trial objective is to compare two very different meditation protocols (Kundalini Yoga and Relaxation Response meditation techniques) to help the OCD treatment.

Detailed Description
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The proposed trial comparing the two different meditation protocols is expected to have two phases: 0-month to 4.5-month period where we compare the Kundalini Yoga protocol with Relaxation Response meditation technique, both on the primary efficacy variable using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and some if not most of the secondary variables using The Dimensional Yale-Brown Obsessive Compulsive Scale (DY-BOCS), Clinical Global Impressions (CGI), Profile of Mood States (POMS), Beck Anxiety Inventory (Beck-A), Beck Depression Inventory (Beck-D), and SF-36 Health Status Questionnaire (SF36). Participants will go to the hospital once a week for a 1,5 hour meditation class.After 4.5-months, all patients will be evaluated and merged together into a single group. Patients will then receive 09 to 12 more months of the meditation protocol. The investigators are expecting to recruit 50 to 60 patients to start. Patients will be blinded to the content of the protocol in the other group at baseline and until one group shows greater efficacy on the primary efficacy variable. The intake physician will be blinded to the treatment groups of the patients.

Official Title
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Randomized Controlled Meditation Trial for Treating OCD Comparing Kundalini Yoga Meditation Versus the Relaxation Response

Conditions
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OCD

Intervention / Treatment
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* Behavioral: Kundalini Yoga Meditation
* Behavioral: Relaxation Response Meditation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of OCD for at least 6 months. A minimum score of 16 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) for the 10-item total score at the baseline screening will be required. The patient must sign and been provided with a copy of an Assent Form for their reference. Exclusion Criteria: Psychoactive prescription medications other than those prescribed for OCD. Spinal problems, or other physically limiting problems. Clinical diagnosis of hypertension, or other cardiovascular problems. Clinical diagnosis of Parkinson's disease. Clinical diagnosis of major depressive disorder with psychotic features, schizophrenia, bipolar disorder, mental retardation, anorexia nervosa, bulimia nervosa, autistic disorder, Asperger's disorder and other forms of pervasive developmental disorder, or traumatic brain. Clinical diagnosis of Tourette's Syndrome. Patients without regular and reliable transportation to the study site. Patients who choose not to participate in meditation and/or chanting (out loud or silently) for personal or religious reasons.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kundalini Yoga Meditation<br>Kundalini Yoga Meditation is going to be use as therapy for OCD, and it will be compare with Relaxation Response Meditation. | Behavioral: Kundalini Yoga Meditation<br>* The trial will compare two very different meditation protocols. After the 4.5 month the patients will be reevaluated, and all patients will be merged together into a single group. Patients will then receive 9 - 12 more months of the meditation protocol.<br>|
| Active Comparator: Relaxation Response Meditation<br>Relaxation Response Meditation is going to be use as therapy for OCD, and it will be compare with Kundalini Yoga Meditation. | Behavioral: Relaxation Response Meditation<br>* The trial will compare two very different meditation protocols. After the 4.5 month the patients will be reevaluated, and all patients will be merged together into a single group. Patients will then receive 9 - 12 more months of the meditation protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Yale-Brown Obsessive Compulsive Scale (YBOCS) | The Yale-Brown Obsessive Compulsive Scale, sometimes referred to as Y-BOCS, is a test to rate the severity of obsessive-compulsive disorder (OCD) symptoms. | Up to 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS) | The Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS): an instrument for assessing obsessive-compulsive symptom dimensions. | Up to 16 months | 
| Clinical Global Impressions (CGI) |  | Up to 16 months | 
| Profile of Mood States (POMS) |  | Up to 16 months | 
| Beck Anxiety Inventory (Beck-A) |  | Up to 16 months | 
| Beck Depression Inventory (Beck-D) |  | Up to 16 months | 
| SF-36 Health Status Questionnaire (SF36) |  | Up to 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCD, YBOCS