Internet-delivered Psychological Treatment of Functional Gastrointestinal Disorders

Официальное название

Internet-delivered Psychological Treatment of Functional Gastrointestinal Disorders - A Danish Feasibility Study

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое 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 reg

Первичные конечные точки

• Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRSIBS; Wiklund et al. 2003) [Срок оценки: 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) [Срок оценки: Measured at baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up]

Вторичные конечные точки (10)

• ROME IV [Срок оценки: Baseline and 3 month follow-up]
• NIAS: Nine Item Avoidant/Restrictive Food Intake disorder screen [Срок оценки: At screening (before inclusion) and 3 month follow-up]
• Bodily Distress Syndrome Checklist (BDS Checklist; Budtz-Lilly et al., 2015) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: end of treatment (i.e. after 10 weeks of treatment),]
• Mind-wandering in daily life (Kane et al. 2007) [Срок оценки: 5 times a day over 2 seperate weeks (week 2 and 8)]

Критерии участия

Критерии включения

• 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.

\-

Критерии исключения

• \- 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 14531531
• Van 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. PMID 27144624
• Tracey, 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. PMID 27965844
• Schmulson MJ, Drossman DA. What Is New in Rome IV. J Neurogastroenterol Motil. 2017 Apr 30;23(2):151-163. doi: 10.5056/jnm16214. PMID 28274109
• Sankarpandi 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. PMID 28184173
• Petersen 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. PMID 32094442

Идентификаторы

NCT: NCT07636122 · FGID pilot study · ID: 147092

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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