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临床试验/NCT03545074
NCT03545074已完成不适用

Efficacy of Spanish or English Language Versions of Mindfulness Meditation on Depression: A Randomized Controlled Trial in Spanish or English Speaking Cohorts

University of California, Los Angeles0 个研究点目标入组 76 人开始时间: 2016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
76
主要终点
Beck Depression Inventory

研究概览

简要总结

This study explores the differential efficacy of Spanish or English versions of a mindfulness intervention on Depression levels, using a pre test post test design and an active control condition (health education).

详细描述

This study is a randomized controlled trial (RCT) with an experimental condition (MAPs Mindfulness intervention) and an active control group (Health Education), using a pretest and immediate posttest research design. Both conditions are comprised of a 6-week group intervention, which will be administered at the UCLA Westwood Medical Campus. The sample (N=80) will be drawn from a population of adults (18-65 years old), residing within a 10mile radius of the UCLA Westwood Medical Campus. To determine initial eligibility, potential participants will self-select based on perceived high levels of stress. Participants will respond self-report questionnaires to assess for psychological symptoms and will be drawn blood samples (180ml total) to assess levels of pro inflammatory cytokines before and after the interventions. Participants will attend a total of 8 visits.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • In order to determine eligibility, interested participants will be phone screened. To qualify for the study, participants have to be fluent in either Spanish or English, validated by self-report at phone screening. Additionally, during the phone screening participants had to complete a 4-item version of the Perceived Stress Scale (Cohen & Williamson, 1988) and score above the 50th percentile (a score of 9 or higher) in order to be eligible

排除标准

  • People not meeting any of the above criteria.

研究组 & 干预措施

Mindfulness Spanish

Experimental

The MAPs program was developed at UCLA (Winston & Smalley, 2010 and Lopez-Maya, 2016) and provides experiential training in mindfulness-based practices, including mindfulness meditation. UCLA-certified instructors delivered the interventions. Active program components include sitting and walking meditations, body scan and loving-kindness meditation. Participants were provided with audio CDs or digital downloads to complete their daily meditation assignments. Sessions were held once per week for 2 hours per session over a period of six consecutive weeks. Home practice assignments consist of daily mindfulness exercises starting with 5 minutes daily, progressing to 20 minutes daily by the end of the program.

干预措施: Mindful Awareness Practices- Spanish (Behavioral)

Mindfulness English

Experimental

The MAPs program was developed at UCLA (Winston & Smalley, 2010) and provides experiential training in mindfulness-based practices, including mindfulness meditation. UCLA-certified instructors delivered the interventions. Active program components include sitting and walking meditations, body scan and loving-kindness meditation. Participants were provided with audio CDs or digital downloads to complete their daily meditation assignments. Sessions were held once per week for 2 hours per session over a period of six consecutive weeks. Home practice assignments consist of daily mindfulness exercises starting with 5 minutes daily, progressing to 20 minutes daily by the end of the program.

干预措施: Mindful Awareness Practices- English (Behavioral)

Health Education Spanish

Active Comparator

The health education condition is a weekly 2-hour, 6 session course aimed at knowledge acquisition in subjects related to health care in general. Similar interventions have been described elsewhere (Black, et al., 2014; Irwin, et al., 2014). A trained health educator provided videos and didactic presentations on topics such as: stress, sleep hygiene, diet & nutrition, sexuality, mental health and substance abuse. The health education condition resembled the MAPs intervention in terms of duration, group format and support, attention and participant expectancy regarding health benefits.

干预措施: Health Education - Spanish (Behavioral)

Health Education English

Active Comparator

The health education condition is a weekly 2-hour, 6 session course aimed at knowledge acquisition in subjects related to health care in general. Similar interventions have been described elsewhere (Black, et al., 2014; Irwin, et al., 2014). A trained health educator provided videos and didactic presentations on topics such as: stress, sleep hygiene, diet & nutrition, sexuality, mental health and substance abuse. The health education condition resembled the MAPs intervention in terms of duration, group format and support, attention and participant expectancy regarding health benefits.

干预措施: Health Education - English (Behavioral)

结局指标

主要结局

Beck Depression Inventory

时间窗: 6 weeks

The Beck Depression Inventory (BDI) is a 21-item self-reporting questionnaire for evaluating the severity of depression in normal and psychiatric populations

次要结局

  • Five Facet Mindfulness Questionnaire(6 weeks)
  • Perceived Stress Scale(6 weeks)
  • Positive and Negative Affect Schedule(6 weeks)
  • IL6(6 weeks)
  • Self Compassion Scale(6 weeks)
  • TNFa(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Lopez, PhD

Postdoctoral Fellow

University of California, Los Angeles

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