search
Back to results

Mindfulness-Based Yoga Intervention for Women With Depression

Primary Purpose

Depression, Depressive Symptoms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness-based Yoga
Walking Control Condition
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, yoga, mindfulness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Mindfulness-based Yoga

    Walking Control Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Beck Depression Inventory
    Change from Baseline Depression at 3 months

    Secondary Outcome Measures

    Ruminative Responses Scale
    Change from Baseline Rumination at 3 months
    Five Facet Mindfulness Questionnaire
    Change from Baseline Mindfulness at 3 months
    Perceived Stress Scale
    Change from Perceived Stress at 3 months
    Pittsburgh Sleep Scale
    Change from Baseline Sleep at 3 months
    Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form
    Change from Baseline Quality of LIfe Enjoyment and Satisfaction at 3 months

    Full Information

    First Posted
    December 7, 2015
    Last Updated
    December 14, 2015
    Sponsor
    University of Minnesota
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02630758
    Brief Title
    Mindfulness-Based Yoga Intervention for Women With Depression
    Official Title
    Mindfulness-Based Yoga Intervention for Women With Depression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    May 2014 (Actual)
    Study Completion Date
    May 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Minnesota

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    This study was a prospective, randomized controlled intervention pilot study conducted in a metropolitan city in the upper Midwest of the United States. Forty women who met the criteria for depression based on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV (SCID-I; First, Spitzer, Gibbon, & Williams, 1997)were randomized to an experimental mindfulness-based yoga condition (n=20) or a walking control condition (n=20). Both programs were home-based motivational sessions delivered over the telephone and lasted 12 weeks. Assessments were conducted at baseline, three months (i.e., post-intervention), one-month follow-up (i.e., one month after the intervention ended). Participants were instructed to continue their usual depression care. The primary dependent variable was depressive symptoms based on the Beck Depression Inventory (BDI). The secondary dependent variable was rumination scores on the Ruminative Responses Scale (RRS). This protocol was approved by the University of Minnesota's Institutional Review Board (IRB). Participants completed informed consent forms sent through the mail; consent to participate in physical activity was also obtained from the participant's healthcare provider. Recruitment for this trial occurred from February, 2013 to January, 2014 and follow-up assessments were completed by May, 2014.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression, Depressive Symptoms
    Keywords
    depression, yoga, mindfulness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mindfulness-based Yoga
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Walking Control Group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness-based Yoga
    Intervention Description
    See study arm description.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Walking Control Condition
    Intervention Description
    See study arm description.
    Primary Outcome Measure Information:
    Title
    Beck Depression Inventory
    Description
    Change from Baseline Depression at 3 months
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Ruminative Responses Scale
    Description
    Change from Baseline Rumination at 3 months
    Time Frame
    3 months
    Title
    Five Facet Mindfulness Questionnaire
    Description
    Change from Baseline Mindfulness at 3 months
    Time Frame
    3 months
    Title
    Perceived Stress Scale
    Description
    Change from Perceived Stress at 3 months
    Time Frame
    3 months
    Title
    Pittsburgh Sleep Scale
    Description
    Change from Baseline Sleep at 3 months
    Time Frame
    3 months
    Title
    Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form
    Description
    Change from Baseline Quality of LIfe Enjoyment and Satisfaction at 3 months
    Time Frame
    3 months
    Other Pre-specified Outcome Measures:
    Title
    Body Mass Index
    Description
    Change from Baseline Body Mass Index at 3 months
    Time Frame
    3 months
    Title
    7-Day Physical Activity Recall
    Description
    Change from Baseline Physical Activity at 3 months
    Time Frame
    3 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Beth A Lewis, PHD, L.P.
    Organizational Affiliation
    University of Minnesota
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Mindfulness-Based Yoga Intervention for Women With Depression

    We'll reach out to this number within 24 hrs