Virtual adjunctive gut-directed hypnotherapy for people with Crohn's disease: A randomized controlled pilot and feasibility trial

Abstract

BackgroundGut-directed hypnotherapy appears to be a promising adjunctive treatment for people with Crohn's disease. The primary objective of this pilot trial was to evaluate feasibility and acceptability of virtually delivered hypnotherapy to determine the parameters for a future definitive trial. MethodsThis prospective, single-site, randomized controlled pilot and feasibility trial compared a 7-week course of virtually delivered adjunctive gut-directed hypnotherapy to standard medical treatment only for adults with Crohn's disease. Primary outcomes were study feasibility and intervention acceptability. Secondary outcomes were objective disease activity and patient-reported outcomes. Assessments took place at five time-points: baseline, post-intervention, and follow-up three-, six-, and 12-months post-intervention. Key resultsRecruitment took place between July 2020 and August 2021 at a tertiary hospital. Recruitment was initially slow and subsequently expanded to community settings. Thirty-seven participants were enrolled in the trial: 95% were retained at post-intervention and 76% at 12-months. Completion of online assessments was high (97–100% across all time-points) whilst objective data collection was low (34–44%). Most intervention participants completed all hypnotherapy sessions (88%) and reported being extremely satisfied (73%), despite 60% experiencing technical issues. Conclusion & inferencesVirtually delivered hypnotherapy was acceptable to participants. Certain aspects of the trial including online assessment were feasible, while recruitment and objective data collection were challenges. Undertaking a future definitive trial will require broader recruitment scope and significant funding for widespread objective data collection. Trial registrationAustralian and New Zealand Clinical Trials Registry ANZCTR#1260000348954.