Holistic Approaches to Depression (HAD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Butler Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Butler Hospital
ClinicalTrials.gov Identifier:
NCT01384916
First received: June 28, 2011
Last updated: November 18, 2013
Last verified: November 2013
  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:

  1. 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.
  2. No current hazardous drug/ alcohol use.
  3. 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.
  4. Benefit from current treatment. Participants must report at least some benefit from their current antidepressant.
  5. No significant suicidality, defined by a QIDS item #12 score < 2 or PI judgement.
  6. Currently taking an antidepressant for depression, at a minimally therapeutic dose. Participant has been taking an antidepressant for at least 8 weeks.
  7. Antidepressant dose has not changed in the 4 weeks prior to study entry; Not planning to change antidepressant dosage in next 10 weeks.
  8. (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.
  9. Medically cleared for moderate exercise, documented by a note from their primary care provider.
  10. Not pregnant or planning on becoming pregnant in the next year.
  11. 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.
  12. Does not practice meditation at home weekly or more often.
  13. Understands English sufficiently well to complete study assessment.
  14. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384916

Contacts
Contact: Monica Broughton, BA 401-455-6487 mbroughton@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:
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: November 18, 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 July 23, 2014