ABSTRACT
Background: Persons with primary biliary cholangitis (PBC) experience significantly higher rates of mental distress and impaired health related quality of life (HrQoL) than the general population. Given limited evidence, but a high need, our primary aim was to assess feasibility and acceptability of a 12-week, online, mind-body wellness program in people with PBC. Methods: This was a single-group, sequential mixed-methods, pre-post feasibility, and acceptability study. Core program components included follow-along movement, meditation and breathwork videos, and cognitive behavioural therapy informed activities. This was supplemented by weekly phone check-ins. Feasibility was assessed by recruitment, adherence, and retention. The pre-post exploratory efficacy assessment included surveys for fatigue, perceived stress, anxiety, depression, HrQoL, and resilience. A qualitative descriptive approach with semi-structured interviews evaluated study experiences. Results: Thirty-two participants were recruited within 30 days and 29 (91%) were retained to end-of-study. Of these, 25 (86%) adhered to carrying out the mind-body practice at least 2-3 days per week. Feedback supported acceptability (satisfaction score 90%). Significant improvements were observed in fatigue (13%, p = 0.004), anxiety (30%, p = 0.005), depression (28%, p = 0.004), and five PBC-40 domains (itch, fatigue, cognitive, emotional, general symptoms). Qualitative interviews revealed improved stress management, better coping, and a more positive mindset. Fatigue and self-sabotaging thoughts were cited as barriers to participation. Conclusions: These findings suggest that a 12-week online mind-body intervention is feasible and acceptable in patients with PBC. After iterative refinement, a randomized controlled trial will be designed using this feedback.
ABSTRACT
BACKGROUND AND AIMS: People with primary biliary cholangitis (PBC) experience high rates of mental distress and fatigue despite standard of care therapy. We aimed to assess the impact of an online mind-body intervention on these symptoms. METHODS: This 12-week RCT used sequential mixed-methods evaluation. Alongside standard of care, participants with primary biliary cholangitis were randomized to receive weekly countdown emails, or the intervention consisting of (i) a weekly 20-30 minute-mind-body follow-along video, (ii) weekly 5-10-minute psychology-based "managing chronic disease skills videos," and (iii) 10-minute telephone check-ins. The primary outcome was a change in the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes evaluated changes in fatigue, perceived stress, resilience, and health-related quality of life. ANCOVA determined between-group differences. RESULTS: Of the 87 randomized patients (control group: n = 44, intervention group: n = 43), the between-group HADS total score improved by 20.0% (95% CI 4.7, 35.2, p = 0.011). Significant improvements were seen in depression (25.8%), perceived stress (15.2%), and 2 primary biliary cholangitis-40 domains [emotional symptoms (16.3%) and social symptoms (11.8%)] with a mean satisfaction of 82/100. This corresponded with end-of-study qualitative findings. Although no improvements were observed in fatigue in the main analysis, a significant benefit was observed in the subgroup of intervention participants (20/36;56%) who completed the mind-body video routine at least 3 times per week. CONCLUSION: This intervention improved measures of mental wellness and quality of life with high satisfaction and reasonable adherence. Future studies could explore strategies to optimize adherence and target fatigue.
