Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000678594p
Ethics application status
Submitted, not yet approved
Date submitted
13/03/2024
Date registered
28/05/2024
Date last updated
28/05/2024
Date data sharing statement initially provided
28/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of functional gut symptoms in patients with quiescent inflammatory bowel disease and irritable bowel syndrome - A single-blinded parallel trial assessing efficacy of app-delivered gut-directed hypnotherapy versus psychoeducation
Scientific title
Treatment of functional gut symptoms in patients with quiescent inflammatory bowel disease and irritable bowel syndrome - A single-blinded parallel trial assessing efficacy of app-delivered gut-directed hypnotherapy versus psychoeducation
Secondary ID [1] 311677 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 333139 0
Irritable Bowel Syndrome 333140 0
Condition category
Condition code
Oral and Gastrointestinal 329835 329835 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 329836 329836 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328143 0
Treatment: Other
Comparator / control treatment
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.

Control: Participants receiving the control treatment will download an app specifically designed for this study onto their personal mobile device. The mobile delivered app will guide participants through daily psychoeducation for six weeks, each session taking approximately 10-15 minutes to complete. This will include information and support to better understand and cope with IBS such as, educating the participant on IBS, dispelling myths about IBS, explaining the brain–gut axis, the physiological stress response, and rationale for behavioral treatment. All psychoeducation is provided via written text
Control group
Active

Outcomes
Primary outcome [1] 337601 0
Co-primary endpoint will be IBS-SSS and a change of at least 30% abdominal pain from baseline, in line with Food and Drug Administration (FDA) recommendations for clinically significant change of IBS on completion of the intervention.
Timepoint [1] 337601 0
Baseline and at completion of the 6-week intervention
Secondary outcome [1] 432473 0
Fatigue
Timepoint [1] 432473 0
Baseline and at completion of the 6-week intervention
Secondary outcome [2] 432479 0
Quality of Life
Timepoint [2] 432479 0
Baseline and at completion of the 6-week intervention
Secondary outcome [3] 432480 0
Physical, mental, and social health. This will be assessed as a composite outcome
Timepoint [3] 432480 0
Baseline and at completion of the 6-week intervention
Secondary outcome [4] 432481 0
Anxiety and Depression. This will be assessed as a composite outcome.
Timepoint [4] 432481 0
Baseline and at completion of the 6-week intervention
Secondary outcome [5] 432482 0
Diet
Timepoint [5] 432482 0
Baseline and at completion of the 6-week intervention
Secondary outcome [6] 432762 0
Depression and Anxiety. This will be assessed as a composite outcome.
Timepoint [6] 432762 0
Baseline and at completion of the 6-week intervention
Secondary outcome [7] 432763 0
Psychiatric symptoms and psychological distress. This will be assessed as a composite outcome.
Timepoint [7] 432763 0
Baseline and at completion of the 6-week intervention
Secondary outcome [8] 432764 0
Biomarkers of Barrier Function
Timepoint [8] 432764 0
Baseline and at completion of the 6-week intervention
Secondary outcome [9] 432765 0
Microbiome and metabolomics analyses. This will be assessed as a composite outcome.
Timepoint [9] 432765 0
Baseline and at completion of the 6-week intervention

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316006 0
Commercial sector/Industry
Name [1] 316006 0
Mindset Health Pty Ltd
Country [1] 316006 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318155 0
None
Name [1] 318155 0
Address [1] 318155 0
Country [1] 318155 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314830 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 314830 0
https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee country [1] 314830 0
Australia
Date submitted for ethics approval [1] 314830 0
08/04/2024
Approval date [1] 314830 0
Ethics approval number [1] 314830 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132862 0
Dr Emma Halmos
Address 132862 0
Block B, Level 6, The Alfred Centre, 99 Commerical Road, Melbourne VIC 3000
Country 132862 0
Australia
Phone 132862 0
+61 407324779
Fax 132862 0
Email 132862 0
Emma.Halmos@monash.edu
Contact person for public queries
Name 132863 0
Emma Halmos
Address 132863 0
Block B, Level 6, The Alfred Centre, 99 Commerical Road, Melbourne VIC 3000
Country 132863 0
Australia
Phone 132863 0
+61 407324779
Fax 132863 0
Email 132863 0
Emma.Halmos@monash.edu
Contact person for scientific queries
Name 132864 0
Emma Halmos
Address 132864 0
Block B, Level 6, The Alfred Centre, 99 Commerical Road, Melbourne VIC 3000
Country 132864 0
Australia
Phone 132864 0
+61 407324779
Fax 132864 0
Email 132864 0
Emma.Halmos@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.