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 < 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.
Conclusions: 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.
Trial registration: ClinicalTrials.gov. Identifier: NCT03663244. Registered September 10, 2018.
Keywords: ACT Acceptance and commitment therapy; ARSQ The Amsterdam Resting State Questionnaire; Abbreviations; BRS Brief resilience scale; CI Confidence interval; Community Mental Health Services (MeSH); EQ Experiences questionnaire - decentering sub scale; Effectiveness; FFMQ The five facet mindfulness questionnaire; Feasibility studies (MeSH); LSR Locally developed stress reduction intervention; MBSR; MBSR Mindfulness-based stress reduction; Mindfulness; Mindfulness-based Stress Reduction; PSS Perceived stress scale; Pilot Projects (MeSH); Pragmatic Clinical Trial (MeSH); RCT Randomised controlled trial; SCL-5 Hopkins Symptom Check List-5; SCS Self-compassion scale; Stress, Psychological (MeSH); WHO World Health Organization; WHO-5 WHO-5-wellbeing scale.