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临床试验/NCT02630758
NCT02630758已完成不适用

Mindfulness-Based Yoga Intervention for Women With Depression

University of Minnesota0 个研究点目标入组 40 人开始时间: 2013年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
Beck Depression Inventory

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Mindfulness-based Yoga

Experimental

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.

干预措施: Mindfulness-based Yoga (Behavioral)

Walking Control Group

Active Comparator

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.

干预措施: Walking Control Condition (Behavioral)

结局指标

主要结局

Beck Depression Inventory

时间窗: 3 months

Change from Baseline Depression at 3 months

次要结局

  • Ruminative Responses Scale(3 months)
  • Perceived Stress Scale(3 months)
  • Pittsburgh Sleep Scale(3 months)
  • Five Facet Mindfulness Questionnaire(3 months)
  • Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form(3 months)

研究者

申办方类型
Other
责任方
Sponsor

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