Mindfulness-Based Yoga Intervention for Women With Depression
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
The purpose of this study was to examine the efficacy of a 12-week mindfulness-based yoga intervention on depressive symptoms and rumination among depressed women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Feb 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 7, 2015
CompletedFirst Posted
Study publicly available on registry
December 15, 2015
CompletedDecember 15, 2015
December 1, 2015
1.2 years
December 7, 2015
December 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Beck Depression Inventory
Change from Baseline Depression at 3 months
3 months
Secondary Outcomes (5)
Ruminative Responses Scale
3 months
Five Facet Mindfulness Questionnaire
3 months
Perceived Stress Scale
3 months
Pittsburgh Sleep Scale
3 months
Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form
3 months
Other Outcomes (2)
Body Mass Index
3 months
7-Day Physical Activity Recall
3 months
Study Arms (2)
Mindfulness-based Yoga
EXPERIMENTALParticipants in the 12-week mindfulness-based yoga condition were guided by a gentle yoga DVD that included postures (asanas), pranayama (breathing exercises), and relaxation (meditation). Participants were asked to complete 60-75 minutes of the DVD twice per week and were encouraged to do more if they were interested. Following the initial baseline assessment and randomization telephone interview, participants in the yoga group completed weekly 15-minute telephone sessions for the first month and bi-weekly telephone sessions for the second and third for a total of eight sessions over the 12 weeks. The mindfulness telephone sessions were modified from the Mindfulness-Based Stress Reduction.
Walking Control Group
ACTIVE COMPARATORThe 12-week walking control condition included twice-weekly home practice with a 65-minute walking DVD (Sansone, 2008) and eight telephone sessions with the telephone counselor. Participants were asked to complete 60 minutes of the DVD (or other walking) twice weekly and encouraged to do more if they were interested. Participants received telephone sessions on the same schedule as the yoga condition. The education sessions covered a variety of health and wellness related topics.
Interventions
Eligibility Criteria
You may qualify if:
- years of age or older
- a personal history of depression (i.e., ever being told by a healthcare provider that they had depression or given an antidepressant for depression)
- able to read and write in the English language
- able to commit to two sessions (yoga or walking) per week for 12 weeks
- demonstrate a willingness to be randomly assigned to either of the study arms
- be yoga naïve, defined as not taking more than four yoga classes in the past two years and not more than one class in the past month.
You may not qualify if:
- individuals with a history of bipolar disorder or schizophrenia and/or who had been hospitalized for a psychiatric disorder within six months prior to the eligibility screening
- individuals not providing signed informed consent
- individuals reporting any other health problems that would interfere with regular yoga practice or walking sessions
- individuals who engaged in more than 90 minutes of moderate intensity physical activity per week during the month prior to the eligibility screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Beth A Lewis, PHD, L.P.
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2015
First Posted
December 15, 2015
Study Start
February 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
December 15, 2015
Record last verified: 2015-12
Data Sharing
- IPD Sharing
- Will not share