Internet-delivered Psychological Treatment of Functional Gastrointestinal Disorders

NCT07636122 | Not Yet Recruiting

• 2 other identifiers: FGID pilot studyID: 147092
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Brief Summary Functional gastrointestinal disorders (FGID), including irritable bowel syndrome (IBS), are common conditions characterized by recurrent gastrointestinal symptoms that cannot be fully explained by structural disease. FGID are associated with reduced quality of life, functional impairment, psychiatric comorbidity, and high healthcare utilization. Psychological interventions, particularly cognitive behavioral therapy (CBT), have demonstrated beneficial effects in FGID, but access to specialized treatment remains limited. This study aims to evaluate the feasibility, acceptability, and potential clinical effects of a Danish exposure-based internet-delivered cognitive behavioral therapy (iCBT) program for adults with FGID. The intervention has been translated and culturally adapted from a Swedish program with previously documented efficacy. In this single-arm feasibility study, 30 adults with FGID will complete a 10-week therapist-supported iCBT program consisting of psychoeducation, symptom monitoring, identification of avoidance behaviors, exposure exercises, and relapse prevention strategies. Participants will receive asynchronous weekly written support from trained CBT therapists. Feasibility outcomes include treatment adherence and completion, participant satisfaction, treatment credibility, working alliance, adverse effects, and acceptability of the internet platform. Clinical outcomes include gastrointestinal symptom severity and quality of life, alongside measures of illness perceptions, illness worry, emotional distress, behavioral responses, functional symptoms, and spontaneous cognition during rest. Assessments will be conducted at baseline, post-treatment, and 3-month follow-up. The study is conducted in Denmark as part of The Danish FGID Treatment Study through collaboration between Aarhus University Hospital, Regional Hospital Silkeborg, Aarhus University, and Karolinska Institute, Sweden. The findings will inform the future implementation and evaluation of internet-delivered psychological treatment for Danish patients with FGID.

Conditions

Functional Gastrointestinal Disorders (FGID)

Outcome Measures

Primary Outcomes (2)

• Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRSIBS; Wiklund et al. 2003)

  20 item measure of gastrointestinal symptoms measured at a 0-6 scale

  Distributed at baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up

• Irritable Bowel Syndrome Quality of Life (IBS-QOL; Patrick et al., 1998)

  34 items on quality of life measured a a 0-4 scale

  Measured at baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up

Secondary Outcomes (10)

• ROME IV

  Baseline and 3 month follow-up

• NIAS: Nine Item Avoidant/Restrictive Food Intake disorder screen

  At screening (before inclusion) and 3 month follow-up

• Bodily Distress Syndrome Checklist (BDS Checklist; Budtz-Lilly et al., 2015)

  Screening, baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 months follow-up

• Illness Perception Questionnaire (IPQ; Broadbent et al., 2006, 2015)

  Screening, baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up

• Whiteley index (Conradt et al., 2006; Fink et al., 1999)

  Screening, baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up

Other Outcomes (6)

• Expectation for counseling success (ECS; Kim et al., 2005)

  Baseline and end of treatment (i.e. after 10 weeks of treatment),

• Evaluation of the treatment

  end of treatment (i.e. after 10 weeks of treatment),

• Evaluation of assessment at the doctor

  Baseline

Study Arms (1)

Internet-delivered psychological treatment for FGID

EXPERIMENTAL

The i-CBT program consists of 5 modules and takes 10 weeks to complete.

Behavioral: I-CBT

Interventions

I-CBT BEHAVIORAL

Experimental : Internet-delivered psychological treatment for FGID The i-CBT program 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. The therapists are experienced in CBT treatment and will receive regular supervision by the Swedish collaborators. The treatment program consists of the following. 1) Thorough information regarding FGID provided as text. 2) Introduction to basic treatment principles of CBT provided as text. 3) Exercises to help the patients become aware of their FGID symptoms and FGID-related thoughts in daily life. 4) Exercises to help the patients discover what they have been avoiding due to their symptoms (e.g. specific foods, situations or activities). 5) Exposure exercises to previously avoided foods, situations or activities.

Internet-delivered psychological treatment for FGID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Related Publications (35)

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MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Lisbeth Frostholm, Professor

  Department for Functional Disorders, Aarhus University Hospital/Aarhus University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi F Pedersen, Ph.D.

CONTACT

0045-78464310; heidpd@rm.dk

Lise Gormsen, Ph.D.

CONTACT

0045-78464310; lisegorm@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility study

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: June 9, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share