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Completed

NCT Number: NCT01833442

Randomized Controlled Meditation Trial for Treating OCD

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

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Key information

Conditions

OCD

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sao Paulo

São Paulo, 01454-010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kundalini Yoga Meditation

Behavioral

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

Behavioral

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

  1. The Yale-Brown Obsessive Compulsive Scale (YBOCS)

    Time frame: Up to 16 months

    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.

Secondary outcomes

  1. The Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS)

    Time frame: Up to 16 months

    The Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS): an instrument for assessing obsessive-compulsive symptom dimensions.

  2. Clinical Global Impressions (CGI)

    Time frame: Up to 16 months

  3. Profile of Mood States (POMS)

    Time frame: Up to 16 months

  4. Beck Anxiety Inventory (Beck-A)

    Time frame: Up to 16 months

  5. Beck Depression Inventory (Beck-D)

    Time frame: Up to 16 months

  6. SF-36 Health Status Questionnaire (SF36)

    Time frame: Up to 16 months

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 16, 2013
Registry last updated
Oct 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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