Complement Ther Clin Pract. 2023 Nov:53:101791.doi: 10.1016/j.ctcp.2023.101791. Epub 2023 Jul 29.

Taryn Lores ¹, Subhadra Evans ², Anna Chur-Hansen ³, Jane M Andrews ⁴, Charlotte Goess ⁴, Lorelle Smith ⁴, David Skvarc ², Antonina A Mikocka-Walus ²

Author information

¹Deakin University, Melbourne, Australia; Central Adelaide Local Health Network (CALHN), Adelaide, Australia. Electronic address: taryn.lores2@sa.gov.au.

²Deakin University, Melbourne, Australia.

³The University of Adelaide, Adelaide, Australia.

⁴CALHN, Adelaide, Australia.

Abstract

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.