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Holistic Approaches to Depression (HAD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01384916
First Posted: June 29, 2011
Last Update Posted: April 13, 2016
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.
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Butler Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Holistic Approaches to Depression

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) ]
    Depression


Enrollment: 121
Study Start Date: June 2011
Study Completion Date: March 2015
Primary Completion Date: August 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT01384916


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

Additional Information:
Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT01384916     History of Changes
Other Study ID Numbers: NR012005
1R01NR012005-01A1 ( U.S. NIH Grant/Contract )
First Submitted: June 28, 2011
First Posted: June 29, 2011
Last Update Posted: April 13, 2016
Last Verified: April 2016

Keywords provided by Butler Hospital:
depression
yoga
health education
antidepressant

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders