• Lise Juul, Karen Johanne Pallesen, Mette Bjerggaard, Corina Nielsen, and Lone Overby Fjorback.
• Department of Clinical Medicine, Danish Center for Mindfulness, Aarhus University, Gudrunsvej 78, 3, 8220, Brabrand, Denmark. lise.juul@clin.au.dk.
• Bmc Public Health. 2020 Mar 30; 20 (1): 409.

BackgroundThe 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.MethodsA 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 Criteria1) 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.ResultsWe 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.ConclusionsAn 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.Trial RegistrationClinicalTrials.gov. Identifier: NCT03663244. Registered September 10, 2018.

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