A pilot randomised trial comparing a mindfulness-based stress reduction course, a locally-developed stress reduction intervention and a waiting list control group in a real-life municipal health care setting.
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ABSTRACT: BACKGROUND: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. METHODS: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. RESULTS: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
SUBMITTER: Juul L
PROVIDER: S-EPMC7106861 | biostudies-literature | 2020 Mar
REPOSITORIES: biostudies-literature
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