NCT01384916

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for phase_2 depression

Timeline
Completed

Started Jun 2011

Typical duration for phase_2 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 13, 2016

Status Verified

April 1, 2016

Enrollment Period

3.2 years

First QC Date

June 28, 2011

Last Update Submit

April 12, 2016

Conditions

Depression

Keywords

depressionyogahealth educationantidepressant

Outcome Measures

Primary Outcomes (1)

  • Quick Inventory of Depressive Symptoms (QIDS)

    Depression

    End of acute phase (10 weeks)

Study Arms (2)

Yoga

EXPERIMENTAL
Behavioral: Yoga

Health education

ACTIVE COMPARATOR
Behavioral: Healthy Living Workshop

Interventions

YogaBEHAVIORAL

2x weekly

Yoga
Healthy Living WorkshopBEHAVIORAL

2x weekly

Health education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

  • Nugent NR, Brick L, Armey MF, Tyrka AR, Ridout KK, Uebelacker LA. Benefits of Yoga on IL-6: Findings from a Randomized Controlled Trial of Yoga for Depression. Behav Med. 2021 Jan-Mar;47(1):21-30. doi: 10.1080/08964289.2019.1604489. Epub 2019 May 29.

    PMID: 31141465DERIVED

MeSH Terms

Conditions

DepressionHealth Education

Interventions

Yoga

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Lisa A Uebelacker, PhD

    Butler Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2011

First Posted

June 29, 2011

Study Start

June 1, 2011

Primary Completion

August 1, 2014

Study Completion

March 1, 2015

Last Updated

April 13, 2016

Record last verified: 2016-04

Locations

US(1)