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Holistic Approaches to Depression (HAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01384916
Recruitment Status : Completed
First Posted : June 29, 2011
Last Update Posted : April 13, 2016
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Butler Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Depression Behavioral: Yoga Behavioral: Healthy Living Workshop Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Holistic Approaches to Depression
Study Start Date : June 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Yoga Behavioral: Yoga
2x weekly

Active Comparator: Health education Behavioral: Healthy Living Workshop
2x weekly

Primary Outcome Measures :
  1. Quick Inventory of Depressive Symptoms (QIDS) [ Time Frame: End of acute phase (10 weeks) ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01384916

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United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
National Institute of Nursing Research (NINR)
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Principal Investigator: Lisa A Uebelacker, PhD Butler Hospital

Additional Information:
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Responsible Party: Butler Hospital Identifier: NCT01384916     History of Changes
Other Study ID Numbers: NR012005
1R01NR012005-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016
Keywords provided by Butler Hospital:
health education
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders