An interventional study of Kundalini Yoga Meditation and Relaxation Response Meditation in OCD, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-10-11.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
The trial objective is to compare two very different meditation protocols (Kundalini Yoga and Relaxation Response meditation techniques) to help the OCD treatment.
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.
University of Sao Paulo is the lead sponsor of 1,032 studies on the registry; 93 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 is going to be use as therapy for OCD, and it will be compare with Kundalini Yoga Meditation.
Behavioral: 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.
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.
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.
Time frame: Up to 16 months
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.
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
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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