Holistic Approaches to Depression

Phase 2

Completed

• Conditions: Depression
• Interventions: Behavioral: Healthy Living Workshop; Behavioral: Yoga

• Registration Number: NCT01384916
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-28
• Study First Posted: 2011-06-29
• Primary Completion: 2014-08
• Study Completion: 2015-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health education	Healthy Living Workshop	-
Yoga	Yoga	-

Primary Outcome Measures

Name	Time	Method
Quick Inventory of Depressive Symptoms (QIDS)	End of acute phase (10 weeks)	Depression

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States