Skip to main content
OpenTrials
Completed

NCT Number: NCT02630758

Mindfulness-Based Yoga Intervention for Women With Depression

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness-Based Yoga

Behavioral

See study arm description.

Walking Control Condition

Behavioral

See study arm description.

Primary outcomes

  1. Beck Depression Inventory

    Time frame: 3 months

    Change from Baseline Depression at 3 months

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 15, 2015
Registry last updated
Dec 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.