Asher Center, Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, 676 N St. Clair St, Chicago, IL, 60611, USA.
Division of Biostatistics, Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Trials. 2023 Feb 17;24(1):115. doi: 10.1186/s13063-022-07012-2.
Mindfulness-based interventions have been shown to improve psychological outcomes including stress, anxiety, and depression in general population studies. However, effectiveness has not been sufficiently examined in racially and ethnically diverse community-based settings. We will evaluate the effectiveness and implementation of a mindfulness-based intervention on depressive symptoms among predominantly Black women at a Federally Qualified Health Center in a metropolitan city.
In this 2-armed, stratified, individually randomized group-treated controlled trial, 274 English-speaking participants with depressive symptoms ages 18-65 years old will be randomly assigned to (1) eight weekly, 90-min group sessions of a mindfulness-based intervention (M-Body), or (2) enhanced usual care. Exclusion criteria include suicidal ideation in 30 days prior to enrollment and regular (>4x/week) meditation practice. Study metrics will be assessed at baseline and 2, 4, and 6 months after baseline, through clinical interviews, self-report surveys, and stress biomarker data including blood pressure, heart rate, and stress related biomarkers. The primary study outcome is depressive symptom score after 6 months.
If M-Body is found to be an effective intervention for adults with depressive symptoms, this accessible, scalable treatment will widely increase access to mental health treatment in underserved, racial/ethnic minority communities.
ClinicalTrials.gov NCT03620721. Registered on 8 August 2018.
基于正念的干预措施已被证明可以改善心理结果，包括在一般人群研究中的压力、焦虑和抑郁。然而，在种族和民族多样化的社区环境中，其有效性尚未得到充分检验。我们将评估一项基于正念的干预措施在大都市城市的一家联邦合格健康中心的主要为黑人女性中对抑郁症状的有效性和实施情况。
在这项 2 臂、分层、个体随机分组治疗对照试验中，将 274 名年龄在 18-65 岁之间、有抑郁症状且讲英语的参与者随机分配到（1）8 周、每周 90 分钟的基于正念的干预组（M-Body），或（2）增强的常规护理。排除标准包括在入组前 30 天内有自杀意念和定期（>4 次/周）冥想练习。研究指标将在基线和基线后 2、4 和 6 个月通过临床访谈、自我报告调查以及包括血压、心率和应激相关生物标志物在内的应激生物标志物数据进行评估。主要研究结果是 6 个月后的抑郁症状评分。
如果 M-Body 被发现是一种有效的针对有抑郁症状的成年人的干预措施，那么这种易于获得、可扩展的治疗方法将广泛增加在服务不足的、种族/民族少数群体社区中获得心理健康治疗的机会。
ClinicalTrials.gov NCT03620721。于 2018 年 8 月 8 日注册。
