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Mindset Health is running a randomized clinical trial in partnership with Monash University comparing the efficacy of an app-delivered gut-directed hypnotherapy program with psychoeducation in patients with irritable bowel syndrome (IBS).
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).
Gut-directed hypnotherapy
Participants in the gut-directed hypnotherapy treatment will be required to download an app specifically designed for this study onto their personal mobile devices. The mobile-delivered app will guide participants through daily gut-directed hypnotherapy recordings and psychoeducation over a six-week period. It is anticipated that it will take 15-20 minutes to complete the recording and psychoeducation each day.
Psychoeducation (control)
Participants in the psychoeducation treatment will be required to download an app specifically designed for this study onto their personal mobile devices. The mobile-delivered app will guide participants through daily psychoeducation readings over a six-week period. It is anticipated that completing these readings will take 10-15 minutes each day.
Endpoints
Primary endpoint
- The change in overall and individual gastrointestinal symptom scores measured on the VAS on completion of each of the treatment conditions.
Secondary endpoints
- Assessment of psychological status in patients on completion of each of the treatment conditions.
- The long-term effectiveness of the treatment conditions.
Conclusion
While the Nerva program has shown to be efficacious through retrospective analysis, rigorous clinical trial testing will hopefully confirm our results.
By partnering with Monash University, Mindset Health is utilizing unbiased, third-party researchers and data analysis to complete the study so as not to cast bias on the results.
Results are expected approximately within a one-year timeframe.
If you are interested in collaborating on research with Mindset Health, please contact Claire Davidson, Research Lead, claire@mindsethealth.com
