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临床试验/NCT03662581
NCT03662581
终止
不适用

Evaluating a Primary-Care Group-based Mindfulness Program

McMaster University1 个研究点 分布在 1 个国家目标入组 80 人2018年11月30日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Anxiety
发起方
McMaster University
入组人数
80
试验地点
1
主要终点
Generalized Anxiety Disorder - 7 (GAD-7)
状态
终止
最后更新
5年前

概览

简要总结

The study evaluates the effectiveness of a group-based mindfulness program conducted in a primary care setting. This study also aims to identify any scale-up and implementation considerations for the program.

详细描述

A primary care group-based mindfulness program was developed by community physicians and co-op and public health students in Ajax, Ontario. The program was started in January 2018 and is run through the Ajax Harwood Clinic, which is a clinic housing a Family Health Organization (FHO) comprising of 5 physicians and approximately 6,500 patients. The purposes of the program are: 1. To teach mindfulness skills for stress reduction, self-compassion, and dealing with difficult thoughts and emotions, 2. To promote an integrative concept of health, which treats the whole person 3. To promote community building and positive relationships 4. To capitalize on the power of groups to: 1. Foster peer-to-peer learning and support when it comes to coping with life challenges 2. Combat isolation 3. Increase efficiency, quality, and timeliness of care This study evaluates the 8-week rolling admission mindfulness program, by first doing a retrospective chart review to identify effect sizes and then conducting a before-after study evaluation of the effect of the mindfulness program on key mental health outcome measures.

注册库
clinicaltrials.gov
开始日期
2018年11月30日
结束日期
2020年12月30日
最后更新
5年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Principal Investigator
主要研究者

Elizabeth Alvarez

Assistant Professor

McMaster University

入排标准

入选标准

  • Be enrolled in mindfulness-based program through Ajax Harwood Clinic
  • Age of 18
  • English-speaking ability to participate in program
  • Able to provide informed consent

排除标准

  • no formal exclusion criteria

结局指标

主要结局

Generalized Anxiety Disorder - 7 (GAD-7)

时间窗: Change from baseline each week until 8 weeks and at 8 months post-baseline

The GAD-7 is a validated instrument for the diagnosis and treatment response of anxiety disorders (Spitzer et al, 2006; Hinz et al, 2017). It is comprised of 7 questions with 4 answer options, ranging from "not at all" to "nearly every day" and scored 0-3 with a total score ranging from 0-21 (Spitzer et al, 2006). Scores of 5-9, 10-14, and 15-21 represent mild, moderate and severe generalized anxiety disorder, respectively. In the primary care setting, the GAD-7 has high diagnostic validity, with a threshold of 10 exhibiting a sensitivity of 89% and specificity of 82% for generalized anxiety disorder (Spitzer et al, 2006). Other conditions related to generalized anxiety disorder including panic disorder, social anxiety disorder and post-traumatic stress disorder have also been sensitive to a GAD-7 score of 10 (Kroenke et al, 2007).

次要结局

  • Insomnia Severity Index (ISI)(Change from baseline each week until 8 weeks and at 8 months post-baseline)
  • Patient Heath Questionnaire 9 (PHQ-9) for depression(Change from baseline each week until 8 weeks and at 8 months post-baseline)
  • DeJong Gierveld Loneliness Scale(Change from baseline each week until 8 weeks and at 8 months post-baseline)

研究点 (1)

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