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

Background: Gut-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.
Methods: This 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 Results: Recruitment 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 & Inferences: Virtually 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 Registration: Australian and New Zealand Clinical Trials Registry ANZCTR#1260000348954.
Competing Interests: Declaration of competing interest AC-H, SE, CG, LS and AM-W: all declare nil conflicts of interest. TL: declares speaker's fees from Janssen. DS: declares research support from Deakin University, the Sydney Parker Smith bequest, and the Medical Research Future Fund (APP1200214). JMA: declares speaker's fees, advisory Board fees and educational/research grants paid to her institution from: Abbott, AbbVie, Allergan, Anatara, AstraZeneca, Bayer, BMS 2020, Celegene, Celltrion, Falk, Ferring, Gilead, Hospira, Immuninc, ImmunsanT, Janssen, MSD, Nestle, Novartis, Pfizer, Sandoz, Shire, Takeda, Vifor, RAH research Fund, The Hospital Research Fund 2020–2022, The Helmsley Trust 2020–2023.
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