Clinical trial NCT01833442: Randomized Controlled Meditation Trial for Treating OCD
Official title: Randomized Controlled Meditation Trial for Treating OCD Comparing Kundalini Yoga Meditation Versus the Relaxation Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OCD
Keywords: OCD
YBOCS
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Yale-Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: Up to 16 months
Secondary outcomes:
measure: The Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS)
timeFrame: Up to 16 months
measure: Clinical Global Impressions (CGI)
timeFrame: Up to 16 months
measure: Profile of Mood States (POMS)
timeFrame: Up to 16 months
measure: Beck Anxiety Inventory (Beck-A)
timeFrame: Up to 16 months
measure: Beck Depression Inventory (Beck-D)
timeFrame: Up to 16 months
measure: SF-36 Health Status Questionnaire (SF36)
timeFrame: Up to 16 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Euripedes C Miguel, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.