Functional Gastrointestinal Disorders (FGID)NCT07636122
Internet-delivered Psychological Treatment of Functional Gastrointestinal Disorders
A study testing I-CBT in people with Functional Gastrointestinal Disorders (FGID), run by University of Aarhus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Gastrointestinal Disorders (FGID)
- What is being tested?
- I-CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2026to 20 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- - 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Internet-delivered Psychological Treatment of Functional Gastrointestinal Disorders - A Danish Feasibility Study
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.
Read more
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.
Read the detailed description
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).
- Being tested
- I-CBT
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-CBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered psychological treatment for FGID | Experimental | The i-CBT program consists of 5 modules and takes 10 weeks to complete. Receives: Behavioral: I-CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRSIBS; Wiklund et al. 2003)
20 item measure of gastrointestinal symptoms measured at a 0-6 scale
Measured: 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: Measured at baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
Secondary outcomes (10)
ROME IV
Measures gastrointestinal symptoms, 5 items at a 0-8 scale
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
8 items measured at a 0-4 scale
Measured: Screening, baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
Symptom Check List - Anxiety and Depression subscales (SCL-ANX &´SCL-DEP; Christensen et al., 2005; Derogatis, 1983)
Symptoms of anxiety and depression, 13 items measured at a 0-4 scale
Measured: Screening, baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
Questionnaire on healthcare consumption and productivity losses for patients with a psychiatric disorder (TiC-P; Bouwmans et al., 2013)
Working hours and sick leave, 10 items of which 6 items are mesured as days 3 items as dichotomized (yes/no)
1 item measured at a 0-10 scale
Measured: Baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
Amsterdam Resting State Questionnaire (ARSQ; Diaz et al., 2013, 2014)
44 items of which 36 items are measured at a 0-4 scale 6 measured as dichotomized (yes/no)
1 item on a 1-4 scale
1 open space to write a comment
Measured: Baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
Patient global impression of change (PGIC; Guy, 1976; Perrot & Lantéri- Minet, 2019)
Self-perceived change, 1 items measured at 5 point scale (0-4)
Measured: end of treatment (i.e. after 10 weeks of treatment),
Mind-wandering in daily life (Kane et al. 2007)
Mind-wandering measured 5 times a day over 2 seperate weeks with 5 items measured at a 0-4 scale
Measured: 5 times a day over 2 seperate weeks (week 2 and 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start30 May 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Functional Gastrointestinal Disorders (FGID)Studies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Lisbeth Frostholm, Professor, Principal investigator, Department for Functional Disorders, Aarhus University Hospital/Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636122
- Sponsor's protocol ID
- FGID pilot study
- Other IDs
- ID: 147092
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study, and we have not yet decided on procedures of sharing data
Publications
World Health Organization (WHO) (1998). SCAN. Schedules for Clinical Assessment in Neuropsychiatry. Geneva: WHO.
Wiklund IK, Fullerton S, Hawkey CJ, Jones RH, Longstreth GF, Mayer EA, Peacock RA, Wilson IK, Naesdal J. An irritable bowel syndrome-specific symptom questionnaire: development and validation. Scand J Gastroenterol. 2003 Sep;38(9):947-54. doi: 10.1080/00365520310004209.
PubMed 14531531Van Oudenhove L, Crowell MD, Drossman DA, Halpert AD, Keefer L, Lackner JM, Murphy TB, Naliboff BD, Levy RL. Biopsychosocial Aspects of Functional Gastrointestinal Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00218-3. doi: 10.1053/j.gastro.2016.02.027. Online ahead of print.
PubMed 27144624Tracey, T. J., & Kokotovic, A. M. (1989). Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology, 1, 207-210. https://doi.org/10.1037/1040-3590.1.3.207
Thabane L, Hopewell S, Lancaster GA, Bond CM, Coleman CL, Campbell MJ, Eldridge SM. Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials. Pilot Feasibility Stud. 2016 May 20;2:25. doi: 10.1186/s40814-016-0065-z. eCollection 2016.
PubMed 27965844Schmulson MJ, Drossman DA. What Is New in Rome IV. J Neurogastroenterol Motil. 2017 Apr 30;23(2):151-163. doi: 10.5056/jnm16214.
PubMed 28274109Sankarpandi SK, Baldwin AJ, Ray J, Mazza C. Reliability of inertial sensors in the assessment of patients with vestibular disorders: a feasibility study. BMC Ear Nose Throat Disord. 2017 Feb 2;17:1. doi: 10.1186/s12901-017-0034-z. eCollection 2017.
PubMed 28184173Petersen MW, Schroder A, Jorgensen T, Ornbol E, Meinertz Dantoft T, Eliasen M, Benros ME, Fink P. Irritable bowel, chronic widespread pain, chronic fatigue and related syndromes are prevalent and highly overlapping in the general population: DanFunD. Sci Rep. 2020 Feb 24;10(1):3273. doi: 10.1038/s41598-020-60318-6.
PubMed 32094442Perrot S, Lanteri-Minet M. Patients' Global Impression of Change in the management of peripheral neuropathic pain: Clinical relevance and correlations in daily practice. Eur J Pain. 2019 Jul;23(6):1117-1128. doi: 10.1002/ejp.1378. Epub 2019 Mar 18.
PubMed 30793414Patrick DL, Drossman DA, Frederick IO, DiCesare J, Puder KL. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci. 1998 Feb;43(2):400-11. doi: 10.1023/a:1018831127942.
PubMed 9512138Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15.
PubMed 22426087Ljotsson B, Hesser H, Andersson E, Lackner JM, El Alaoui S, Falk L, Aspvall K, Fransson J, Hammarlund K, Lofstrom A, Nowinski S, Lindfors P, Hedman E. Provoking symptoms to relieve symptoms: a randomized controlled dismantling study of exposure therapy in irritable bowel syndrome. Behav Res Ther. 2014 Apr;55:27-39. doi: 10.1016/j.brat.2014.01.007. Epub 2014 Feb 10.
PubMed 24584055Ljotsson B, Hedman E, Andersson E, Hesser H, Lindfors P, Hursti T, Rydh S, Ruck C, Lindefors N, Andersson G. Internet-delivered exposure-based treatment vs. stress management for irritable bowel syndrome: a randomized trial. Am J Gastroenterol. 2011 Aug;106(8):1481-91. doi: 10.1038/ajg.2011.139. Epub 2011 May 3.
PubMed 21537360Ljotsson B, Falk L, Vesterlund AW, Hedman E, Lindfors P, Ruck C, Hursti T, Andreewitch S, Jansson L, Lindefors N, Andersson G. Internet-delivered exposure and mindfulness based therapy for irritable bowel syndrome--a randomized controlled trial. Behav Res Ther. 2010 Jun;48(6):531-9. doi: 10.1016/j.brat.2010.03.003. Epub 2010 Mar 16.
PubMed 20362976Lancaster GA, Thabane L. Guidelines for reporting non-randomised pilot and feasibility studies. Pilot Feasibility Stud. 2019 Oct 6;5:114. doi: 10.1186/s40814-019-0499-1. eCollection 2019.
PubMed 31608150
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Psychological Treatment of Functional Gastrointestinal Disorders - A Danish Feasibility Study
- ClinicalTrials.gov ID
- NCT07636122
- Acronym / sponsor ID
- FGID pilot study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered psychological treatment for FGID | Experimental | Behavioral: I-CBTThe i-CBT program consists of 5 modules and takes 10 weeks to complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-CBTExperimental : 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. | Behavioural | Internet-delivered psychological treatment for FGID |
Primary outcome
Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRSIBS; Wiklund et al. 2003)
Time frame: Distributed at baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
20 item measure of gastrointestinal symptoms measured at a 0-6 scale
Irritable Bowel Syndrome Quality of Life (IBS-QOL; Patrick et al., 1998)
Time frame: Measured at baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
34 items on quality of life measured a a 0-4 scale
10 secondary outcomes
ROME IV
Time frame: Baseline and 3 month follow-up
NIAS: Nine Item Avoidant/Restrictive Food Intake disorder screen
Time frame: At screening (before inclusion) and 3 month follow-up
Bodily Distress Syndrome Checklist (BDS Checklist; Budtz-Lilly et al., 2015)
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)
Time frame: 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)
Time frame: Screening, baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
Symptom Check List - Anxiety and Depression subscales (SCL-ANX &´SCL-DEP; Christensen et al., 2005; Derogatis, 1983)
Time frame: Screening, baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
Questionnaire on healthcare consumption and productivity losses for patients with a psychiatric disorder (TiC-P; Bouwmans et al., 2013)
Time frame: Baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
Amsterdam Resting State Questionnaire (ARSQ; Diaz et al., 2013, 2014)
Time frame: Baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
Patient global impression of change (PGIC; Guy, 1976; Perrot & Lantéri- Minet, 2019)
Time frame: end of treatment (i.e. after 10 weeks of treatment),
Mind-wandering in daily life (Kane et al. 2007)
Time frame: 5 times a day over 2 seperate weeks (week 2 and 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- BackgroundWorld Health Organization (WHO) (1998). SCAN. Schedules for Clinical Assessment in Neuropsychiatry. Geneva: WHO.
- Background: PubMed 14531531Wiklund IK, Fullerton S, Hawkey CJ, Jones RH, Longstreth GF, Mayer EA, Peacock RA, Wilson IK, Naesdal J. An irritable bowel syndrome-specific symptom questionnaire: development and validation. Scand J Gastroenterol. 2003 Sep;38(9):947-54. doi: 10.1080/00365520310004209.
- Background: PubMed 27144624Van Oudenhove L, Crowell MD, Drossman DA, Halpert AD, Keefer L, Lackner JM, Murphy TB, Naliboff BD, Levy RL. Biopsychosocial Aspects of Functional Gastrointestinal Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00218-3. doi: 10.1053/j.gastro.2016.02.027. Online ahead of print.
- BackgroundTracey, T. J., & Kokotovic, A. M. (1989). Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology, 1, 207-210. https://doi.org/10.1037/1040-3590.1.3.207
- Background: PubMed 27965844Thabane L, Hopewell S, Lancaster GA, Bond CM, Coleman CL, Campbell MJ, Eldridge SM. Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials. Pilot Feasibility Stud. 2016 May 20;2:25. doi: 10.1186/s40814-016-0065-z. eCollection 2016.
- Background: PubMed 28274109Schmulson MJ, Drossman DA. What Is New in Rome IV. J Neurogastroenterol Motil. 2017 Apr 30;23(2):151-163. doi: 10.5056/jnm16214.
- Background: PubMed 28184173Sankarpandi SK, Baldwin AJ, Ray J, Mazza C. Reliability of inertial sensors in the assessment of patients with vestibular disorders: a feasibility study. BMC Ear Nose Throat Disord. 2017 Feb 2;17:1. doi: 10.1186/s12901-017-0034-z. eCollection 2017.
- Background: PubMed 32094442Petersen MW, Schroder A, Jorgensen T, Ornbol E, Meinertz Dantoft T, Eliasen M, Benros ME, Fink P. Irritable bowel, chronic widespread pain, chronic fatigue and related syndromes are prevalent and highly overlapping in the general population: DanFunD. Sci Rep. 2020 Feb 24;10(1):3273. doi: 10.1038/s41598-020-60318-6.
- Background: PubMed 30793414Perrot S, Lanteri-Minet M. Patients' Global Impression of Change in the management of peripheral neuropathic pain: Clinical relevance and correlations in daily practice. Eur J Pain. 2019 Jul;23(6):1117-1128. doi: 10.1002/ejp.1378. Epub 2019 Mar 18.
- Background: PubMed 9512138Patrick DL, Drossman DA, Frederick IO, DiCesare J, Puder KL. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci. 1998 Feb;43(2):400-11. doi: 10.1023/a:1018831127942.
- Background: PubMed 22426087Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15.
- Background: PubMed 24584055Ljotsson B, Hesser H, Andersson E, Lackner JM, El Alaoui S, Falk L, Aspvall K, Fransson J, Hammarlund K, Lofstrom A, Nowinski S, Lindfors P, Hedman E. Provoking symptoms to relieve symptoms: a randomized controlled dismantling study of exposure therapy in irritable bowel syndrome. Behav Res Ther. 2014 Apr;55:27-39. doi: 10.1016/j.brat.2014.01.007. Epub 2014 Feb 10.
- Individual participant dataSharing planned: No. This is a pilot study, and we have not yet decided on procedures of sharing data
Related trials for Functional Gastrointestinal Disorders (FGID)
Active, not recruiting
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Small Intestinal Bacterial Overgrowth, SIBO
Recruiting
Mechanism of FODMAP Restriction on FGID Patients
Functional Gastrointestinal Disorders (FGIDs), Irritable Bowel Syndrome (IBS)
Recruiting
A Heart Rate Variability (HRV) Biofeedback Training in Functional Gastrointestinal Disorders (FGID)
Functional Gastrointestinal Disorders (FGIDs)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisbeth Frostholm, Professor principal investigator
Department for Functional Disorders, Aarhus University Hospital/Aarhus University
Questions about this trial
What is this clinical trial studying?
A study testing I-CBT in people with Functional Gastrointestinal Disorders (FGID), run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidi F Pedersen, Ph.D. (0045-78464310, heidpd@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRSIBS; Wiklund et al. 2003) (time frame: Distributed at baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07636122, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.