Internet-delivered Psychological Treatment of Functional Gastrointestinal Disorders

ConditionFunctional Gastrointestinal Disorders (FGID)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Aarhus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

- 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).

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Internet-delivered psychological treatment for FGIDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

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

Time frame

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

Time frame

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

Secondary outcomes

ROME IV

Measures gastrointestinal symptoms, 5 items at a 0-8 scale

Time frame

Baseline and 3 month follow-up

NIAS: Nine Item Avoidant/Restrictive Food Intake disorder screen

Measures food intake, 9 items at a 0-5 scale

Time frame

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

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

25 items on bodily symptoms from 4 organ systems, measured on a 0-4 scale

Time frame

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)

21 items on illness perception measured of which 9 are measured at a 0-10 scale 1 item at a categorical scale consisting of 4 categories 1 open-ended questions on the cause of symptoms (possible to write up to 3 different causes) 10 items measured at a 0-3 scale

Time frame

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

Other outcomes

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

6 items on a 0-10 scale

Time frame

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

Evaluation of the treatment

5 items measured at 0-3 and 3 open-ended questions

Time frame

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

Evaluation of assessment at the doctor

3 items measured at 0-3 and 3 open-ended questions

Time frame

Baseline

Working Alliance Inventory - Short Form (WAI-SF; Tracey & Kokotovic, 1989)

12 items measured at a 0-6 scale

Time frame

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aarhus

Lead sponsor

Aarhus University Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: