Evaluating a Primary-Care Group-based Mindfulness Program
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Generalized Anxiety Disorder - 7 (GAD-7)
研究概览
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:
-
To teach mindfulness skills for stress reduction, self-compassion, and dealing with difficult thoughts and emotions,
-
To promote an integrative concept of health, which treats the whole person
-
To promote community building and positive relationships
-
To capitalize on the power of groups to:
-
Foster peer-to-peer learning and support when it comes to coping with life challenges
-
Combat isolation
-
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
研究组 & 干预措施
Mindfulness Group Program
A primary care mindfulness-based rolling admissions program where subjects must attend 4 of 8 consecutive group sessions, to be considered to have completed the program.
干预措施: Mindfulness Group Program (Behavioral)
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)
研究者
Elizabeth Alvarez
Assistant Professor
McMaster University