Effectiveness of a Biopsychosocial-Based Exercise Approach Delivered in Group and Individual Formats in Primary Sjögren Disease: A Randomized Controlled Trial.

Abstract

To investigate the effectiveness of the BETY (Bilişsel Egzersiz Terapi Yaklaşımı; in English, Cognitive Exercise Therapy Approach), a biopsychosocial model-based exercise intervention in individuals with primary Sjögren disease and compared its group-based and individually delivered formats. Three-arm, parallel, single-blind randomized controlled trial. Rheumatology unit of a university hospital. Sixty individuals with primary Sjögren disease (n=60) were randomized to group-based BETY (n=20), individually delivered BETY (n=20), or a control group (n=20). Participants in the intervention groups received BETY sessions delivered in group-based or individual formats, consisting of 60-minute sessions 3 times per week for 12 weeks; the control group received a home-based exercise program. The primary outcome was biopsychosocial status, assessed using the BETY-Biopsychosocial Questionnaire. Secondary outcomes included disease-related symptoms (dryness, fatigue, pain), disease activity, psychological status, central sensitization, quality of life, and swallowing function. Assessments were performed at baseline and 12 weeks for all groups, with an additional 6-month follow-up conducted only in the BETY intervention groups. Greater improvements in biopsychosocial status were observed in both the group-based (mean difference, -17.25; 95% CI, -28.36 to -6.13; P=.003) and individually delivered BETY interventions (mean difference, -19.90; 95% CI, -31.01 to -8.78; P=.001), compared with the control group. Similarly, the European Alliance of Associations for Rheumatology Sjögren's syndrome patient-reported index improved in both BETY groups (group-based: mean difference, -2.95; 95% CI -4.10 to -1.80; P<.001; individual: mean difference, -2.16; 95% CI, -3.31 to -1.01; P<.001), exceeding the minimal clinically important difference (≥1 point). No adverse events were reported. BETY, delivered in either group-based or individual formats, appears to be a well-tolerated biopsychosocial exercise approach that resulted in improvements across multidimensional outcomes among individuals with primary Sjögren disease.