Internet-delivered Psychological Treatment of Functional Gastrointestinal Disorders

OBJECTIVE: To test the feasibility of an exposure-based internet-based cognitive behavioral therapy (ICBT) treatment not previously evaluated in Denmark for adults with FGID in a Danish clinical context.

DESIGN: This is a feasibility study testing a of an exposure-based I-CBT treatment for FGID not previously evaluated in Denmark.

PARTICIPANTS: 30 adults with functional gastrointestinal disorder

PROJECT GROUP: Lisbeth Frostholm (Principal Investigator); Charlotte Ulrikka Rask (Principal Investigator); Karen Hansen Kallesøe; Heidi Frølund Pedersen; Lotte Fynne; Lise Gormsen (FL); Laura Krogsgaard (FL). Brjann Ljötsson, Erik Hedman

The Danish FGID Treatment Study is a joint cooperation between Regional Hospital Silkeborg, Department of Functional Disorders (FL), Aarhus University Hospital, the Research Unit at the Department of Child and Adolescent Psychiatry (BUA), Aarhus University Hospital, the Department of Clinical Medicine (CM), Aarhus University, and the Department of Clinical Neuroscience (CNS) at the Karolinska Institute in Stockholm, Sweden.

The trial will be conducted by the research group at the Dept. of Functional Disorders (www.functionaldisorders.dk), based at Aarhus University Hospital, Denmark. The clinic was established in 1999 and offers assessment and specialized treatment to patients with severe FSD. Patients are recruited from Regional Hospital Silkeborg

MAIN HYPOTHESIS: The feasibility of the I-CBT program will be assessed positively by the patients. At least 70% of included patients will complete the treatment. Furthermore, the I-CBT program will reduce symptoms of FGID and increase quality of life in patients with FGID.

INTERVENTION: The i-CBT program build on exposure based therapy and consists of 5 modules and takes 10 weeks to complete. The participants will be expected to use approximately 4 hours per week on the treatment. Asynchronous written support will be provided by a therapist on a weekly basis.

MEASUREMENTS: Self-reported measures will be administered to patients at several timepoints during the course of treatment, including before the start of the program (baseline, 0 weeks), after treatment (10 weeks), at the 3-month follow-up (22 weeks, primary endpoint), Beyond this, patients will receive a short daily questionnaire 5 times a day for 2 week (week 2 and week 8 into treatment)

Furthermore, therapist will evaluate patients' progress post-treatment (after 10 weeks). Therapists will record number and time usage of telephone/video consultations throughout the treatment. The treatment program will continually log the participants' data during the treatment period.

For a detailed list of the measures and measurement time points included, see the section "Outcome measures".

ANALYSIS: Data will be presented and analyzed according to current guidelines for feasibility studies

ETHICAL CONSIDERATIONS: The fesibility study presents low risks (side-effects and/or disadvantages) for the patients who may end their participation at any time point and can get into contact with a physician if their physical/mental health state deteriorates significantly. After patients have reached their final end-point, at the 3-month follow-up, they will be invited to a follow-up consultation with a medical doctor where their health/mental status will be assessed, and the need for further treatment discussed.

A study protocol has been approved by the Research Ethics Board of Aarhus University Hospital for approval (case.nr. 1-10-72-127-25). A pre-registration of the study has been submitted to ClinicalTrials.gov before the onset of the feasibility study. Data will be handled according to Danish law on the Data Protection Act and the Data Protection Regulation, and have been approved by the Danish Data Protection Agency (case.nr. 772917).

Inclusion criteria

• Age ≥ 18.
• A primary diagnosis of functional disorders, gastrointestinal, specifically irritable bowel syndrome operationalized by ROME IV (DR58)
• Normal recommended routine medical investigations: growth, blood samples including TSH, total IgA, IgA-tissue transglutaminase, complete blood count, erythrocyte sedimentation rate and C-reactive protein analysis, liver enzymes and fecal calprotectin.
• Refractory gastrointestinal functional symptoms despite medical treatment (in accordance with guidelines)
• Stable dosage of FGID-related medication such as laxatives, Imodium or pain-modulating psychopharmacological medication during the past month.
• Living in Denmark.
• Access to a computer or tablet with an internet connection.

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Exclusion criteria

• - Another disease that explains the symptoms.
• Chronic inflammatory bowel disease (e.g., Crohns, colitis ulcerosa).
• Lactose intolerance, celiac disease, and food allergies, in accordance with guidelines.
• Severe psychiatric problems (e.g., suicidal ideation, depression).
• Insufficient language or computer skills.
• Addiction to alcohol, drugs or medicine.
• Treatment with opioids or other addictive drugs such as benzodiazepines
• Lactose-/gluten-intolerance where the diet has not been adjusted accordingly.
• Severe cognitive or intellectual dysfunction or diagnosed autism spectrum disorder, which prevent the participant from interaction with the program
• Ongoing psychological treatment.