Randomized Controlled Meditation Trial for Treating OCD

OCD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833442
• Other study ID #: Ipq0704/10br
• Status: Completed
• Phase: N/A
• First received: December 4, 2012
• Last updated: October 10, 2017
• Start date: March 2011
• Est. completion date: July 2013

Study information

• Verified date: October 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• OCD

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Clinical Global Impressions (CGI)		Up to 16 months
Secondary	Profile of Mood States (POMS)		Up to 16 months
Secondary	Beck Anxiety Inventory (Beck-A)		Up to 16 months
Secondary	Beck Depression Inventory (Beck-D)		Up to 16 months
Secondary	SF-36 Health Status Questionnaire (SF36)		Up to 16 months