NCT02630758

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

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Feb 2013

Status
completed

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

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
Last Updated

December 15, 2015

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

December 7, 2015

Last Update Submit

December 14, 2015

Conditions

Keywords

depressionyogamindfulness

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

EXPERIMENTAL

Participants 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.

Behavioral: Mindfulness-based Yoga

Walking Control Group

ACTIVE COMPARATOR

The 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.

Behavioral: Walking Control Condition

Interventions

See study arm description.

Mindfulness-based Yoga

See study arm description.

Walking Control Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Beth A Lewis, PHD, L.P.

    University of Minnesota

    STUDY CHAIR

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