Holistic Approaches to Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Yoga

Group Type EXPERIMENTAL

Yoga

Intervention Type BEHAVIORAL

2x weekly

Health education

Group Type ACTIVE_COMPARATOR

Healthy Living Workshop

Intervention Type BEHAVIORAL

2x weekly

Interventions

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Yoga

2x weekly

Intervention Type BEHAVIORAL

Healthy Living Workshop

2x weekly

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No