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Randomized Controlled Trial
. 2023 Nov 6;7(11):e0316.
doi: 10.1097/HC9.0000000000000316. eCollection 2023 Nov 1.

An online mind-body program improves mental health and quality of life in primary biliary cholangitis: A randomized controlled trial

Makayla Watt  1 , Ashley Hyde  1 , Emily Johnson  1 , Gail M Wright  2 , Shauna Vander Well  2 , Chikku Sadasivan  1 , Dayna Lee-Baggley  3 , John C Spence  4 , Andrew Mason  1 , Hin Hin Ko  5 , Edward Tam  5 , Puneeta Tandon  1
Affiliations
Randomized Controlled Trial

An online mind-body program improves mental health and quality of life in primary biliary cholangitis: A randomized controlled trial

Makayla Watt et al. Hepatol Commun. .

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.

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Conflict of interest statement

Dayna Lee-Baggley consults, advises and is on the speaker’s bureau for Novo Nordisk and Bausch. She is employed, owns stock in, and holds intellectual property rights with ImpactMe Workplace Solutions. She is employed and holds intellectual property rights with Harbinger Press. Andrew Mason advises and received grants from Intercept. He consults for GlaxoSmithKline and Ipsen. He received grants from Merck. Hin Hin Ko consults, advises, is on the speakers’ bureau and received grants from Intercept. She consults, advises and is on the speakers’ bureau for Sanofi and AbbVie. She consults and advises Ipsen and Lupin. She is on the speakers’ bureau and received grants from Gilead and Falk. She received grants from Celgene. Edward Tam consults, advises, and is on the speakers’ bureau for AbbVie, Gilead, Merck, Advanz, and Intercept. The remaining authors have no conflicts to report.

Figures

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Graphical abstract
FIGURE 1
FIGURE 1
Patient recruitment and flow through the study.
FIGURE 2
FIGURE 2
Participant satisfaction with core and optional elements of the Peace Power Pack program, scored using a 5-point Likert Scale from very satisfied to very dissatisfied.
See this image and copyright information in PMC

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