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Mindfulness-Based Yoga Intervention for Women With Depression

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ClinicalTrials.gov Identifier: NCT02630758
Recruitment Status : Completed
First Posted : December 15, 2015
Last Update Posted : December 15, 2015
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease Intervention/treatment Phase
Depression Depressive Symptoms Behavioral: Mindfulness-based Yoga Behavioral: Walking Control Condition Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness-Based Yoga Intervention for Women With Depression
Study Start Date : February 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mindfulness-based Yoga

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
See study arm description.

Active Comparator: Walking Control Group

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
See study arm description.




Primary Outcome Measures :
  1. Beck Depression Inventory [ Time Frame: 3 months ]
    Change from Baseline Depression at 3 months


Secondary Outcome Measures :
  1. Ruminative Responses Scale [ Time Frame: 3 months ]
    Change from Baseline Rumination at 3 months

  2. Five Facet Mindfulness Questionnaire [ Time Frame: 3 months ]
    Change from Baseline Mindfulness at 3 months

  3. Perceived Stress Scale [ Time Frame: 3 months ]
    Change from Perceived Stress at 3 months

  4. Pittsburgh Sleep Scale [ Time Frame: 3 months ]
    Change from Baseline Sleep at 3 months

  5. Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form [ Time Frame: 3 months ]
    Change from Baseline Quality of LIfe Enjoyment and Satisfaction at 3 months


Other Outcome Measures:
  1. Body Mass Index [ Time Frame: 3 months ]
    Change from Baseline Body Mass Index at 3 months

  2. 7-Day Physical Activity Recall [ Time Frame: 3 months ]
    Change from Baseline Physical Activity at 3 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630758


Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Study Chair: Beth A Lewis, PHD, L.P. University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02630758     History of Changes
Other Study ID Numbers: 1203P11124
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
depression
yoga
mindfulness

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders