Key takeaways:
- A randomized controlled trial with Monash University is comparing gut-directed hypnotherapy plus psychoeducation against psychoeducation alone in 250 participants with IBS.
- Participants use a mobile app daily for six weeks, with hypnotherapy sessions anticipated to take 15-20 minutes per day and control readings 10-15 minutes.
- The primary endpoint is the change in overall and individual gastrointestinal symptom scores, with psychological status and long-term effectiveness as secondary endpoints.
- While Nerva has shown to be efficacious through retrospective analysis, this rigorous third-party trial aims to confirm those results, with findings expected within approximately one year.
The study began recruiting participants on 13 June 2022. It will run until all 250 participants reach the six-month follow-up. Participants are being recruited through social media advertisements in line with the study protocol.
The study’s aim
The current study’s aim is to compare the effects of gut-directed hypnotherapy (GDH) to psychoeducation (control) on gastrointestinal symptoms and psychological indices in patients with IBS.
It is hypothesized that participants randomized to the GDH treatment will see greater degrees of improvement in terms of overall and individual gastrointestinal symptoms and psychological indices compared to those who receive only psychoeducation (control).
Study protocol
The study will be a randomized controlled trial of six weeks duration. Eligible volunteers will be randomized to one of two treatment conditions.
The two treatment conditions are:
• gut-directed hypnotherapy with psychoeducation
• psychoeducation (control).
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