None listed
Conditions
Brief summary
The treatment of inflammatory bowel disease (IBD) primarily involves targeting inflammation with pharmacological agents, but comorbidities, including functional gut symptoms (DGBI), are common and poorly defined within this population. DGBI diagnosis in IBD is challenging due to confounding factors and reliance on symptom-based criteria. Current assessment methods, such as clinical remission evaluation and biochemical markers, may not accurately identify DGBI in the absence of inflammation. Advances in assessment include intestinal ultrasound for detecting ongoing disease activity and identifying patients with increased intestinal permeability, potentially aiding in distinguishing functional gut symptoms from inflammation-associated symptoms. Limited evidence exists for efficacious treatments for DGBI in IBD, with a notable exception being a trial supporting the use of a low FODMAP diet for symptom relief in patients with quiescent disease. Gut-directed hypnotherapy (GDH) emerges as a potential therapy to reduce symptom burden, offering efficacy comparable to in-person sessions and superior to psychoeducation. However, research on GDH efficacy specifically in patients with truly quiescent IBD is still ongoing.
Interventions
Participants will be randomised to receive app-delivered gut-directed hypnotherapy (GDH) or psychoeduation (control) for 6 weeks. Adherence to both interventions will be available through app analytics.
GDH: Participants receiving GDH treatment will download an app specifically designed for this study onto their personal mobile device. The mobile delivered app will guide participants through daily GDH recordings for six weeks, each recording taking approximately 15-20 minutes to complete. The
Participants will be randomised to receive app-delivered gut-directed hypnotherapy (GDH) or psychoeduation (control) for 6 weeks. Adherence to both interventions will be available through app analytics. GDH: Participants receiving GDH treatment will download an app specifically designed for this study onto their personal mobile device. The mobile delivered app will guide participants through daily GDH recordings for six weeks, each recording taking approximately 15-20 minutes to complete. The GDH involves an induction whereby the participant is invited to relax before suggestions for the control and normalisation of gastrointestinal function are made to the subconscious mind. An example of a metaphor would be to ask the participant to imagine swallowing down medicine and imagining that this medicine provides healing and protection to the gastrointestinal tract thus reducing gastrointestinal symptoms. Hypnotherapy recordings have been prepared by a qualified hypnotherapist (SLP) with experience in the utilisation of GDH.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Adults patients with quiescent IBD (determined by intestinal ultrasound (IUS)), and IBS (based on Rome criteria), who are on stable IBD therapy for at least two months.
Exclusion criteria
Exclusion criteria comprises patients unsuitable for IUS (e.g., obesity, predominant rectal disease), active IBD, coeliac disease, new IBS therapies for the prior four weeks, including change in diet, supplementary probiotics, prebiotics or any medication unrelated to IBD treatment, that might influence GI function, rectal disease with constipation, pregnancy or breastfeeding, ineligibility for Medicare or inability to speak or read English or give informed consent.
Outcome results
None listed