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OpenTrials
Completed

NCT Number: NCT01384916

Holistic Approaches to Depression

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • No current hazardous drug/ alcohol use.
  • 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.
  • Benefit from current treatment. Participants must report at least some benefit from their current antidepressant.
  • No significant suicidality, defined by a QIDS item #12 score < 2 or PI judgement.
  • Currently taking an antidepressant for depression, at a minimally therapeutic dose. Participant has been taking an antidepressant for at least 8 weeks.
  • Antidepressant dose has not changed in the 4 weeks prior to study entry; Not planning to change antidepressant dosage in next 10 weeks.
  • (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.
  • Medically cleared for moderate exercise, documented by a note from their primary care provider.
  • Not pregnant or planning on becoming pregnant in the next year.
  • 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.
  • Does not practice meditation at home weekly or more often.
  • Understands English sufficiently well to complete study assessment.
  • 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.

Treatment and study plan

Yoga

Behavioral

2x weekly

Healthy Living Workshop

Behavioral

2x weekly

Primary outcomes

  1. Quick Inventory of Depressive Symptoms (QIDS)

    Time frame: End of acute phase (10 weeks)

    Depression

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: HAD

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jun 29, 2011
Registry last updated
Apr 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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