Effects of acceptance and commitment therapy plus exercise for older adults with chronic low back pain: A preliminary cluster randomized controlled trial with qualitative interviews.
Chronic low back pain (CLBP) is increasingly prevalent in older adults and often leads to functional disability and depressive symptoms. This 2-arm, double-blinded, pilot cluster RCT, with semi-structured interviews, aimed to evaluate the acceptability, feasibility, and preliminary clinical efficacy of ACT plus exercise training (ACT+Ex) on improving pain-related outcomes, psychological outcomes, and physical fitness in older adults with CLBP at post-treatment and 6-month follow-up. Forty community-dwelling older adults (62-85 years) with CLBP, predominantly female, were randomized to ACT+Ex (n=20) or Education plus exercise program (Edu+Ex) (n=20) for 8 weekly group-based sessions, with assessments at baseline, post-treatment, and 6-month follow-up (primary endpoint). Self-reported outcomes included pain intensity, functional disability (Roland Morris Disability Questionnaires, RMDQ), health-related quality of life (EuroQol-5 Dimensions, EQ-5D-5L), psychological inflexibility (Acceptance and Action Questionnaire-Version 2, AAQ-II), and psychological well-being (Depression Anxiety Stress Scale). Physical fitness was assessed using the functional reach test (FRT), Timed Up and Go test (TUG), 6-minute walk test (6MWT), hand grip strength (HGS), and 30-second sit-to-stand (STS-30) test. This trial achieved high recruitment (23.5 participants per week) and completion rates (92.5%). Exploratory analyses revealed that ACT+Ex significantly improved pain intensity, disability, psychological inflexibility, HRQoL, and physical fitness at post-treatment and 6-month follow-up. Qualitative data identified 3 superordinate themes: previous healthcare experience affecting pain beliefs; acceptance strategies guiding behavioral changes; and facilitators and barriers to treatment compliance. These findings support the need for a definitive RCT and form a valuable basis for future exploration regarding the behavioral mechanisms of ACT in clinical applications. PERSPECTIVE: A multimodal therapy incorporating ACT and exercise promotes positive behavioral changes and its treatment effects are maintained at the 6-month follow-up especially for physical performance.