Effectiveness of Mind-Body Intervention for Inflammatory Conditions: Results from a 26-Week Randomized, Non-Blinded, Parallel-Group Trial

Author: Thao Thi Nguyen1,2,3, Christian G Jensen4, Lina Khoury3, Bent Deleuran5, Esther S Blom4, Thomas Breinholt6, Robin Christensen2,7, Lone Skov3
Affiliation: <sup>1</sup> Unit of Social Medicine, Frederiksberg Hospital, 2000 Frederiksberg, Denmark. <sup>2</sup> Section for Biostatistics and Evidence-Based Research, The Parker Institute, Bispebjerg and Frederiksberg Hospital, 2000 Frederiksberg, Denmark. <sup>3</sup> Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, 2900 Hellerup, Denmark. <sup>4</sup> Department of Psychology, University of Copenhagen, 1165 Copenhagen, Denmark. <sup>5</sup> Department of Rheumatology, Aarhus University Hospital, 8200 Aarhus, Denmark. <sup>6</sup> TV 2 DANMARK A/S, Rugaardsvej 25, 5100 Odense, Denmark. <sup>7</sup> Research Unit of Rheumatology, Department of Clinical Research, Odense University Hospital, University of Southern Denmark, 5000 Odense, Denmark.
Conference/Journal: J Clin Med
Date published: 2021 Jul 14
Other: Volume ID: 10 , Issue ID: 14 , Pages: 3107 , Special Notes: doi: 10.3390/jcm10143107. , Word Count: 243

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.

Keywords: biopsychosocial; health-related quality of life; mind–body intervention; psoriasis; rheumatoid arthritis; treatment-as-usual.

PMID: 34300273 DOI: 10.3390/jcm10143107