Clinical trial NCT02630758: Mindfulness-Based Yoga Intervention for Women With Depression
Official title: Mindfulness-Based Yoga Intervention for Women With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depressive Symptoms
Keywords: depression
yoga
mindfulness
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Beck Depression Inventory
timeFrame: 3 months
Secondary outcomes:
measure: Ruminative Responses Scale
timeFrame: 3 months
measure: Five Facet Mindfulness Questionnaire
timeFrame: 3 months
measure: Perceived Stress Scale
timeFrame: 3 months
measure: Pittsburgh Sleep Scale
timeFrame: 3 months
measure: Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form
timeFrame: 3 months
Other outcomes:
measure: Body Mass Index
timeFrame: 3 months
measure: 7-Day Physical Activity Recall
timeFrame: 3 months
Locations:
Study officials:
affiliation: University of Minnesota
name: Beth A Lewis, PHD, L.P.
role: STUDY_CHAIR
References: