Abstract

Biopsychosocial intervention has been suggested as a complementary treatment strategy for patients with chronic conditions. We compared the effect of a mind–body intervention (MBI), relative to treatment-as-usual (TAU) on WHO-5 Well-being Index during an intensive period of 12 weeks and follow-up at week 26 among patients with either psoriasis (PsO) or rheumatoid arthritis (RA). The MBI was based on the ‘Relaxation Response Resiliency Program’ and the ‘Open and Calm Program’, as well as ‘Mindfulness Based Stress Reduction’ (MBSR). The trial was randomized, management-as-usual, and controlled. Statistical analyses were based on the intention-to-treat population using repeated measures and mixed effects models (NCT03888261). We screened 39 potential participants, 35 of which (PsO, n = 20; RA, n = 15) met the eligibility criteria and were randomized: 17 in the MBI group and 18 in the TAU group. Attrition from the intervention program was 19%, with 65% of MBI patients and 71% of TAU patients completing the outcome assessments. After 12 weeks, a statistically significant difference in WHO-5 was observed between the groups (p = 0.019). However, according to the protocol, during the entire trial period, the average (least squares mean values) WHO-5 score was higher although not statistically significant in the MBI group (65.3) compared with the TAU group (59.1), corresponding to a between-group difference over 26 weeks of 6.15 (95% CI: −0.26 to 12.56; p = 0.060). All things considered, adding biopsychosocial intervention to clinical practice to patients with conditions, such as PsO and RA, could potentially improve health-related quality of life.

Highlights

  • Licensee MDPI, Basel, Switzerland.Chronic diseases are the most costly health conditions worldwide [1,2]

  • Complex psychosocial factors such as depression, stress, work-related dynamics, and thinking patterns are thought to be associated with poor health status and impaired healthrelated quality of life (HR-QoL) among patients suffering from chronic inflammatory conditions such as psoriasis (PsO) and rheumatoid arthritis (RA) [3,4]

  • While the primary analyses were based on all observed data that are valid under the plausible assumption that data are ‘Missing at Random’ (MAR) [26,27], we performed sensitivity analyses to explore the effect of departures from the MAR assumption

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Summary

Introduction

Licensee MDPI, Basel, Switzerland.Chronic diseases are the most costly health conditions worldwide [1,2]. Complex psychosocial factors such as depression, stress, work-related dynamics, and thinking patterns are thought to be associated with poor health status and impaired healthrelated quality of life (HR-QoL) among patients suffering from chronic inflammatory conditions such as psoriasis (PsO) and rheumatoid arthritis (RA) [3,4]. Considering the chronic nature of the diseases and the complex psychosocial factors of PsO and RA, nonpharmacologic therapies, such as biopsychosocial intervention, might be used as a complementary treatment strategy [7,8,9,10,11]. Several nonpharmacological noninvasive therapies, including mind–body interventions, have become available for chronic medical conditions in recent years [12,13,14,15]. Mind–body interventions are often part of the multidisciplinary rehabilitation and incorporate strategies that are thought to improve psychological and physical well-being, aiming to allow patients to take an active role in their treatment and promote people’s ability to cope with their condition and improve

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