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Internet-delivered Psychological Treatment of Functional Gastrointestinal Disorders

4. června 2026 aktualizováno: University of Aarhus

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.

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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).

Typ studie

Intervenční

Zápis (Odhadovaný)

30

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Heidi F Pedersen, Ph.D.
  • Telefonní číslo: 0045-78464310
  • E-mail: heidpd@rm.dk

Studijní záloha kontaktů

  • Jméno: Lise Gormsen, Ph.D.
  • Telefonní číslo: 0045-78464310
  • E-mail: lisegorm@rm.dk

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  1. Age ≥ 18.
  2. A primary diagnosis of functional disorders, gastrointestinal, specifically irritable bowel syndrome operationalized by ROME IV (DR58)
  3. 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.
  4. Refractory gastrointestinal functional symptoms despite medical treatment (in accordance with guidelines)
  5. Stable dosage of FGID-related medication such as laxatives, Imodium or pain-modulating psychopharmacological medication during the past month.
  6. Living in Denmark.

  7. Access to a computer or tablet with an internet connection.

    -

Exclusion Criteria:

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Internet-delivered psychological treatment for FGID
The i-CBT program consists of 5 modules and takes 10 weeks to complete.
Behaviorální: I-CBT
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRSIBS; Wiklund et al. 2003)
Časové okno: 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
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)
Časové okno: 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
Measured at baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
ROME IV
Časové okno: Baseline and 3 month follow-up
Measures gastrointestinal symptoms, 5 items at a 0-8 scale
Baseline and 3 month follow-up
NIAS: Nine Item Avoidant/Restrictive Food Intake disorder screen
Časové okno: At screening (before inclusion) and 3 month follow-up
Measures food intake, 9 items at a 0-5 scale
At screening (before inclusion) and 3 month follow-up
Bodily Distress Syndrome Checklist (BDS Checklist; Budtz-Lilly et al., 2015)
Časové okno: Screening, baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 months follow-up
25 items on bodily symptoms from 4 organ systems, measured on a 0-4 scale
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)
Časové okno: Screening, baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up

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
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)
Časové okno: Screening, baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
8 items measured at a 0-4 scale
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)
Časové okno: Screening, baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
Symptoms of anxiety and depression, 13 items measured at a 0-4 scale
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)
Časové okno: Baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up

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
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)
Časové okno: Baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up

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
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)
Časové okno: end of treatment (i.e. after 10 weeks of treatment),
Self-perceived change, 1 items measured at 5 point scale (0-4)
end of treatment (i.e. after 10 weeks of treatment),
Mind-wandering in daily life (Kane et al. 2007)
Časové okno: 5 times a day over 2 seperate weeks (week 2 and 8)
Mind-wandering measured 5 times a day over 2 seperate weeks with 5 items measured at a 0-4 scale
5 times a day over 2 seperate weeks (week 2 and 8)

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Expectation for counseling success (ECS; Kim et al., 2005)
Časové okno: Baseline and end of treatment (i.e. after 10 weeks of treatment),
6 items on a 0-10 scale
Baseline and end of treatment (i.e. after 10 weeks of treatment),
Evaluation of the treatment
Časové okno: end of treatment (i.e. after 10 weeks of treatment),
5 items measured at 0-3 and 3 open-ended questions
end of treatment (i.e. after 10 weeks of treatment),
Evaluation of assessment at the doctor
Časové okno: Baseline
3 items measured at 0-3 and 3 open-ended questions
Baseline
Working Alliance Inventory - Short Form (WAI-SF; Tracey & Kokotovic, 1989)
Časové okno: end of treatment (i.e. after 10 weeks of treatment),
12 items measured at a 0-6 scale
end of treatment (i.e. after 10 weeks of treatment),
Inventory for the balanced assessment of Negative Effects of Psychotherapy (INEP; Ladwig, Rief & Nestoriuc, 2014)
Časové okno: end of treatment (i.e. after 10 weeks of treatment),
41 items on potential side effects: 16 items measured at 0-3 13 items rating whether a side effect was caused by the treatment (worse, not relevant, better) 2 open ended questions
end of treatment (i.e. after 10 weeks of treatment),
LEVA
Časové okno: end of treatment (i.e. after 10 weeks of treatment),
Evaluation of the internet program, 6 items at a 0-5 scale
end of treatment (i.e. after 10 weeks of treatment),

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Aarhus

Spolupracovníci

Aarhus University Hospital

Vyšetřovatelé

  • Vrchní vyšetřovatel: Lisbeth Frostholm, Professor, Department for Functional Disorders, Aarhus University Hospital/Aarhus University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

30. května 2026

Primární dokončení (Odhadovaný)

1. září 2027

Dokončení studie (Odhadovaný)

20. prosince 2027

Termíny zápisu do studia

První předloženo

13. května 2026

První předloženo, které splnilo kritéria kontroly kvality

4. června 2026

První zveřejněno (Aktuální)

9. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. června 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • FGID pilot study
  • ID: 147092 (Jiné číslo grantu/financování: Trygfonden)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

This is a pilot study, and we have not yet decided on procedures of sharing data

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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