Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Clinical Global Impressions (CGI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Euripedes C Miguel, PHD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sao Paulo | São Paulo | São Paulo | 01454-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31780963 | Derived | 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. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 19, 2019 | |
| Reset | Dec 6, 2019 | |
| Release | Jan 21, 2020 | |
| Reset | Jan 30, 2020 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 19, 2019 | Dec 6, 2019 | |||
| Jan 21, 2020 |
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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 |
| SF-36 Health Status Questionnaire (SF36) | Up to 16 months |
| Jan 30, 2020 |