The purpose of the present study was to conduct a pilot randomised controlled trial (RCT) to lend support to a larger effectiveness RCT comparing Mindfulness-Based Stress Reduction (MBSR), a locally-developed stress reduction intervention (LSR) and a waiting list control group in a Danish municipal health care center setting. A three-armed parallel pilot RCT was conducted among 71 adults who contacted a Danish municipal health care center due to stress-related problems. Recruitment was made between January and April 2018 and followed usual procedures. Exclusion criteria: 1) acute treatment-demanding clinical depression or diagnosis of psychosis or schizophrenia, 2) abuse of alcohol, drugs, medicine, 3) pregnancy. Randomisation was performed by an independent data manager using the REDCap electronic data capture tool. The primary outcome was a description of RCT feasibility (recruitment and retention rates regarding intervention participation and 12-week follow-up). Secondary outcomes were completion rates regarding questionnaire data and proposed effect-estimates of outcome measures considered to be used in the following real RCT. Type of intervention and outcome assessment were not blinded. We recruited 71 of 129 eligible individuals from the target population (55, 95%CI: 46–64). Forty-two (59%) were females. Median age: 44 years (1-quartile:34, 3-quartile:50). Twenty-nine (41%) had < 16 years of education. Forty-eight (68%) were employed; 30 of these 48 (63%) were on sick leave. Mean scores for perceived stress (PSS): 25.4 ± 5.3; symptoms of anxiety and depression (SCL-5): 2.9 ± 0.6, and well-being (WHO-5): 31.7 ± 8.5 indicated a need for intervention. 16/24 (67, 95%CI: 45 to 84) who were allocated to MBSR and 17/23 (74, 95%CI: 52 to 90) who were allocated to LSR participated in ≥5 sessions. The loss to follow-up at 12 weeks: MBSR: 5 (21% (95% CI: 7 to 42), LSR: 5 (22% (95% CI: 7 to 44) and waiting list: 4 (17% (95% CI: 5 to 37). This was acceptable and evenly distributed. The results indicated MBSR to be superior. An RCT assessing the effectiveness of stress reduction interventions in a real-life municipal health care setting is feasible among adults with a clear need for stress reduction interventions based on scores on mental health. ClinicalTrials.gov. Identifier: NCT03663244. Registered September 10, 2018.

中文翻译：

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一项试点随机试验，在现实生活中的市政医疗机构中比较了基于正念的压力减轻课程，本地开发的压力减轻干预措施和候补名单对照组。

本研究的目的是进行一项试验性随机对照试验（RCT），以支持更大的有效性RCT，比较基于正念的压力减轻（MBSR），本地开发的压力减轻干预（LSR）和等待名单控制小组在丹麦市政医疗中心设置。在因压力相关问题而联系丹麦市政医疗中心的71名成年人中进行了三臂并行试点RCT。招聘是在2018年1月至4月之间进行的，并且遵循通常的程序。排除标准：1）急需治疗的临床抑郁症或精神病或精神分裂症的诊断，2）滥用酒精，药物，药物，3）怀孕。由独立的数据管理员使用REDCap电子数据捕获工具进行随机化。主要结果是描述RCT的可行性（有关干预参与和12周随访的招募和保留率）。次要结果是问卷调查数据的完成率，以及在以下实际RCT中考虑使用的结果度量的拟议效果估计。干预类型和结果评估不盲目。我们从目标人群中招募了129名合格人员中的71名（55，95％CI：46–64）。四十二（59％）是女性。中位年龄：44岁（1分位数：34，3分位数：50）。二十九（41％）受过16年以下的教育。雇用了四十八（68％）；这48个中有30个（63％）病假。感知压力（PSS）的平均得分：25.4±5.3；焦虑和抑郁症状（SCL-5）：2.9±0.6，幸福感（WHO-5）：31.7±8.5表明需要干预。分配给MBSR的16/24（67，95％CI：45至84）和分配给LSR的17/23（74，95％CI：52至90）参加了≥5次会议。在第12周失去随访：MBSR：5（21％（95％CI：7至42），LSR：5（22％（95％CI：7至44））和等待名单：4（17％（ 95％CI：5到37），这是可以接受的，而且分布均匀，结果表明MBSR效果更好。RCT评估在现实生活中的市政医疗机构中缓解压力干预措施的有效性在有明确需求的成年人中是可行的基于心理健康评分的压力减轻干预措施。ClinicalTrials.gov。标识符：NCT03663244。注册于2018年9月10日。一项RCT评估在现实生活中的城市卫生保健环境中进行减压干预措施的有效性，对于明显需要基于心理健康得分的减压干预措施的成年人来说，这是可行的。ClinicalTrials.gov。标识符：NCT03663244。2018年9月10日注册。一项RCT评估在现实生活中的城市卫生保健环境中进行减压干预措施的有效性，对于明显需要基于心理健康得分的减压干预措施的成年人来说，这是可行的。ClinicalTrials.gov。标识符：NCT03663244。2018年9月10日注册。