Comparative effectiveness of a mindfulness-based intervention (M-Body) on depressive symptoms: study protocol of a randomized controlled trial in a Federally Qualified Health Center (FQHC).
Comparative effectiveness of a mindfulness-based intervention (M-Body) on depressive symptoms: study protocol of a randomized controlled trial in a Federally Qualified Health Center (FQHC).
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在一般人群研究中，以正念为基础的干预已被证明可以改善心理结果，包括压力、焦虑和抑郁。然而，在种族和民族多样化的社区环境中，有效性尚未得到充分的审查。我们将评估在一个大都市的联邦合格保健中心对主要是黑人妇女的抑郁症状进行的以正念为基础的干预的有效性和实施情况。在这项双臂、分层、单独随机分组治疗的对照试验中，274名年龄在18-65岁、有抑郁症状的说英语的参与者将被随机分配到(1)每周8次、每次90分钟的正念干预（M-Body）组，或(2)强化常规护理。排除标准包括入组前30天内有自杀意念，并定期（每周40次）冥想练习。研究指标将通过临床访谈、自我报告调查和压力生物标志物数据（包括血压、心率和压力相关生物标志物），在基线和基线后2、4和6个月进行评估。主要研究结果为6个月后抑郁症状评分。如果M-Body被发现对患有抑郁症状的成年人是一种有效的干预措施，这种可获得的、可扩展的治疗将广泛增加服务不足的种族/少数民族社区获得心理健康治疗的机会。ClinicalTrials.gov NCT03620721。于2018年8月8日注册。
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.
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影响因子：
2.9
作者：
Dutton, Mary Ann;Bermudez, Diana;Myers, Neely L.
通讯作者：
Myers, Neely L.
影响因子：
2.3
作者：
Conner, Kyaien O.;Lee, Brenda;Brown, Charlotte
通讯作者：
Brown, Charlotte
DOI：
10.1023/b:mhsr.0000024351.12294.65
发表时间：
2004-06-01
期刊：
Mental health services research
影响因子：
--
作者：
Aarons, Gregory A
通讯作者：
Aarons, Gregory A
影响因子：
3.8
作者：
Alegria, Margarita;Chatterji, Pinka;Meng, Xiao-Li
通讯作者：
Meng, Xiao-Li
影响因子：
3.6
作者：
Burnett-Zeigler, Inger;Satyshur, Maureen D.;Moskowitz, Judith
通讯作者：
Moskowitz, Judith