Mindfulness-Based Yoga Intervention for Women With Depression

Depression Clinical Trial

Official title:

Mindfulness-Based Yoga Intervention for Women With Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02630758
• Other study ID #: 1203P11124
• Status: Completed
• Phase: N/A
• First received: December 7, 2015
• Last updated: December 14, 2015
• Start date: February 2013
• Est. completion date: May 2014

Study information

• Verified date: December 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Symptoms

Intervention

Behavioral:
• Mindfulness-based Yoga
See study arm description.
• Walking Control Condition
See study arm description.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Mass Index	Change from Baseline Body Mass Index at 3 months	3 months	No
Other	7-Day Physical Activity Recall	Change from Baseline Physical Activity at 3 months	3 months	No
Primary	Beck Depression Inventory	Change from Baseline Depression at 3 months	3 months	No
Secondary	Ruminative Responses Scale	Change from Baseline Rumination at 3 months	3 months	No
Secondary	Five Facet Mindfulness Questionnaire	Change from Baseline Mindfulness at 3 months	3 months	No
Secondary	Perceived Stress Scale	Change from Perceived Stress at 3 months	3 months	No
Secondary	Pittsburgh Sleep Scale	Change from Baseline Sleep at 3 months	3 months	No
Secondary	Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form	Change from Baseline Quality of LIfe Enjoyment and Satisfaction at 3 months	3 months	No