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Internet-delivered Psychological Treatment of Functional Gastrointestinal Disorders

2026년 6월 4일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

개입 / 치료

상세 설명

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).

연구 유형

중재적

등록 (추정된)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Heidi F Pedersen, Ph.D.
  • 전화번호: 0045-78464310
  • 이메일: heidpd@rm.dk

연구 연락처 백업

  • 이름: Lise Gormsen, Ph.D.
  • 전화번호: 0045-78464310
  • 이메일: lisegorm@rm.dk

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Internet-delivered psychological treatment for FGID
The i-CBT program consists of 5 modules and takes 10 weeks to complete.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRSIBS; Wiklund et al. 2003)
기간: 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)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
ROME IV
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)

기타 결과 측정

결과 측정
측정값 설명
기간
Expectation for counseling success (ECS; Kim et al., 2005)
기간: 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
기간: 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
기간: Baseline
3 items measured at 0-3 and 3 open-ended questions
Baseline
Working Alliance Inventory - Short Form (WAI-SF; Tracey & Kokotovic, 1989)
기간: 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)
기간: 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
기간: 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),

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Lisbeth Frostholm, Professor, Department for Functional Disorders, Aarhus University Hospital/Aarhus University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 30일

기본 완료 (추정된)

2027년 9월 1일

연구 완료 (추정된)

2027년 12월 20일

연구 등록 날짜

최초 제출

2026년 5월 13일

QC 기준을 충족하는 최초 제출

2026년 6월 4일

처음 게시됨 (실제)

2026년 6월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 4일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • FGID pilot study
  • ID: 147092 (기타 보조금/기금 번호: Trygfonden)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다