Holistic Approaches to Depression (HAD)
This study is currently recruiting participants.
Verified May 2013 by Butler Hospital
Sponsor:
Butler Hospital
Collaborator:
Information provided by (Responsible Party):
Butler Hospital
ClinicalTrials.gov Identifier:
NCT01384916
First received: June 28, 2011
Last updated: May 1, 2013
Last verified: May 2013
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Purpose
The purpose of the study is to investigate whether yoga or a health education group alleviate depressive symptoms for an individual with a partial response to antidepressant medication.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Behavioral: Yoga Behavioral: Healthy Living Workshop |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Holistic Approaches to Depression |
Resource links provided by NLM:
Further study details as provided by Butler Hospital:
Primary Outcome Measures:
- Quick Inventory of Depressive Symptoms (QIDS) [ Time Frame: End of acute phase (10 weeks) ] [ Designated as safety issue: Yes ]Depression
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Yoga |
Behavioral: Yoga
2x weekly
|
| Active Comparator: Health education |
Behavioral: Healthy Living Workshop
2x weekly
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Meets criteria for major depressive disorder (MDD) within the past two years; no history of bipolar disorder, schizophrenia, or psychotic symptoms in one's lifetime.
- No current hazardous drug/ alcohol use.
- Depression symptom severity. Participants must have a Quick Inventory of Depressive Symptoms (QIDS) score greater than or equal to 8 and less than or equal to 17.
- Benefit from current treatment. Participants must report at least some benefit from their current antidepressant.
- No significant suicidality, defined by a QIDS item #12 score < 2 or PI judgement.
- Currently taking an antidepressant for depression, at a minimally therapeutic dose. Participant has been taking an antidepressant for at least 8 weeks.
- Antidepressant dose has not changed in the 4 weeks prior to study entry; Not planning to change antidepressant dosage in next 10 weeks.
- (If in psychotherapy). Therapist and therapy frequency has not changed in the past 6 weeks AND not planning to change it in the next 3 months.
- Medically cleared for moderate exercise, documented by a note from their primary care provider.
- Not pregnant or planning on becoming pregnant in the next year.
- Naïve to study interventions. Participants cannot have had > 4 single sessions (or > 8 total hours class time) of yoga, other classes in "mindful exercise," (e.g., qigong, tai chi), mindfulness based stress reduction, or health education in the past year or >8 single classes of yoga within the past 2 years of the same. Participants can not have practiced yoga at least once per week for 8 weeks in a row in the past 5 years.
- Does not practice meditation at home weekly or more often.
- Understands English sufficiently well to complete study assessment.
- Biomarker exclusions. Participants who are taking oral steroids, insulin or oral hypoglycemic agents, or oral antibiotics, or who refuse blood draws, will not participate in the biomarker component of the study; however, they may participate in the rest of the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384916
Contacts
| Contact: Morganne Kraines, BA | 401-455-6487 | mkraines@butler.org |
Locations
| United States, Rhode Island | |
| Butler Hospital | Recruiting |
| Providence, Rhode Island, United States, 02906 | |
Sponsors and Collaborators
Butler Hospital
Investigators
| Principal Investigator: | Lisa A Uebelacker, PhD | Butler Hospital |
More Information
Additional Information:
Related Info 
No publications provided
| Responsible Party: | Butler Hospital |
| ClinicalTrials.gov Identifier: | NCT01384916 History of Changes |
| Other Study ID Numbers: | NR012005, 1R01NR012005-01A1 |
| Study First Received: | June 28, 2011 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Butler Hospital:
|
depression yoga health education antidepressant |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013