Overview

This trial is active, not recruiting.

Condition ocd
Treatments kundalini yoga meditation, relaxation response meditation
Sponsor University of Sao Paulo
Start date March 2011
End date July 2012
Trial size 50 participants
Trial identifier NCT01833442, Ipq0704/10br

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Kundalini Yoga Meditation is going to be use as therapy for OCD, and it will be compare with Relaxation Response Meditation.
kundalini yoga meditation Kundalini Yoga Meditation
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.
(Active Comparator)
Relaxation Response Meditation is going to be use as therapy for OCD, and it will be compare with Kundalini Yoga Meditation.
relaxation response meditation Relaxation Response Meditation
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.

Primary Outcomes

Measure
The Yale-Brown Obsessive Compulsive Scale (YBOCS)
time frame: Up to 16 months

Secondary Outcomes

Measure
The Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS)
time frame: Up to 16 months
Clinical Global Impressions (CGI)
time frame: Up to 16 months
Profile of Mood States (POMS)
time frame: Up to 16 months
Beck Anxiety Inventory (Beck-A)
time frame: Up to 16 months
Beck Depression Inventory (Beck-D)
time frame: Up to 16 months
SF-36 Health Status Questionnaire (SF36)
time frame: Up to 16 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Randomized Controlled Meditation Trial for Treating OCD Comparing Kundalini Yoga Meditation Versus the Relaxation Response
Principal investigator Euripedes C Migule, PHD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by University of Sao Paulo.