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.

Study Overview

• Status: Completed
• Conditions: Depression; Depressive Symptoms
• Intervention / Treatment: Behavioral: Mindfulness-based Yoga; Behavioral: Walking Control Condition

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory	Change from Baseline Depression at 3 months	3 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	Change from Baseline Body Mass Index at 3 months	3 months
7-Day Physical Activity Recall	Change from Baseline Physical Activity at 3 months	3 months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Study Chair: Beth A Lewis, PHD, L.P., University of Minnesota

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: December 7, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 15, 2015

Study Record Updates

• Last Update Posted (Estimate): December 15, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: depression; mindfulness; yoga
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 1203P11124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO