The Development, Feasibility, Acceptability, and Efficacy of a 12-Week Online Mind-Body Intervention for People with Primary Biliary Cholangitis
Creators: Watt, Makayla Elizabeth
Publisher: name: University of Alberta Library
Year: 2022

<p>Introduction: Persons with primary biliary cholangitis (PBC) experience significantly higher rates of mental distress, impaired health related quality of life (HrQoL), and fatigue than the general population. While mind-body interventions have been shown to improve mental health and HrQoL, and reduce fatigue in other chronic disease populations, there is limited evidence in PBC. <br>
Objectives: The purpose of these studies were to determine the feasibility, acceptability and efficacy of a 12-week online mind-body intervention for people with PBC.<br>
Methods: For the pilot study, the intervention was assessed through a single group sequential mixed-methods pre-post feasibility study (Chap 4). It included a core program of follow-along movement, meditation and breathwork videos, and supplementary content including tips from PBC physicians and cognitive behavioral therapy informed activities. Feasibility was assessed by recruitment, adherence and retention and acceptability was assessed through a survey at the end of the program. A pre-post exploratory efficacy assessment included surveys for anxiety, depression, stress, resilience, HrQoL, and fatigue. A qualitative descriptive approach with semi-structured interviews was used to evaluate study experiences. The intervention was revised using feedback from the pilot study and the efficacy of the intervention was assessed through a sequential mixed-methods randomized controlled trial (RCT) (Chap 5). The primary outcome was changes in the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes evaluated fatigue, perceived stress, resilience and HrQoL. ANCOVA was used to determine between group differences. A qualitative descriptive approach with semi-structured interviews evaluated study experiences.<br>
Results: For the pilot study, 32 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%). The exploratory efficacy assessment revealed significant improvements in fatigue (13%, p=0.004), anxiety (30%, p=0.005), depression (28%, p=0.022) and five PBC-40 domains (itch, fatigue, cognitive, emotional, general symptoms). Qualitative interviews supported improved stress management, better coping, and a more positive mindset. Fatigue and self-sabotaging thoughts were cited as barriers to participation. For the RCT, 123 patients were screened and 87 were randomized (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) and the HADS depression score improved by 25.8% (95% CI 4.8, 46.8, p=0.017). Significant improvements were seen in perceived stress (15.2%), and two PBC-40 domains (emotional symptoms (16.3%), and social symptoms (11.8%)) with a mean satisfaction of 82/100. While no significant improvements were observed in fatigue, interviews revealed improved coping with fatigue. Of the 36/43 participants who completed the intervention, 20 (56%) completed the program at least 3x per week. <br>
Conclusion: The 12-week virtually-supported home exercise program was feasible and acceptable and demonstrated positive impacts on measures of mental health and quality of life. Future studies could explore strategies to optimize adherence and increase scalability of the intervention and could increase the physical activity intervention, which may result in a greater impact on fatigue.</p>