NCT01833442

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

2.3 years

First QC Date

December 4, 2012

Last Update Submit

October 10, 2017

Conditions

OCD

Keywords

OCDYBOCS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

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

    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

  • +1 more secondary outcomes

Study Arms (2)

Kundalini Yoga Meditation

ACTIVE COMPARATOR

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

Relaxation Response Meditation

ACTIVE COMPARATOR

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

Interventions

Kundalini Yoga MeditationBEHAVIORAL

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.

Kundalini Yoga Meditation
Relaxation Response MeditationBEHAVIORAL

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 01454-010, Brazil

Location

Related Publications (1)

  • Shannahoff-Khalsa D, Fernandes RY, Pereira CAB, March JS, Leckman JF, Golshan S, Vieira MSR, Polanczyk GV, Miguel EC, Shavitt RG. Kundalini Yoga Meditation Versus the Relaxation Response Meditation for Treating Adults With Obsessive-Compulsive Disorder: A Randomized Clinical Trial. Front Psychiatry. 2019 Nov 11;10:793. doi: 10.3389/fpsyt.2019.00793. eCollection 2019.

    PMID: 31780963DERIVED

Study Officials

  • Euripedes C Miguel, PHD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairmain of psychiatry Departament of University os Sao Paulo

Study Record Dates

First Submitted

December 4, 2012

First Posted

April 16, 2013

Study Start

March 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

October 11, 2017

Record last verified: 2017-10

Locations

BR(1)