Internet-delivered Psychological Treatment of Functional Gastrointestinal Disorders
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Heidi F Pedersen, Ph.D.
- Número de teléfono: 0045-78464310
- Correo electrónico: heidpd@rm.dk
Copia de seguridad de contactos de estudio
- Nombre: Lise Gormsen, Ph.D.
- Número de teléfono: 0045-78464310
- Correo electrónico: lisegorm@rm.dk
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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.
-
Exclusion Criteria:
- - 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRSIBS; Wiklund et al. 2003)
Periodo de tiempo: 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
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Distributed at baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
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Irritable Bowel Syndrome Quality of Life (IBS-QOL; Patrick et al., 1998)
Periodo de tiempo: Measured at baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
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34 items on quality of life measured a a 0-4 scale
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Measured at baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
ROME IV
Periodo de tiempo: Baseline and 3 month follow-up
|
Measures gastrointestinal symptoms, 5 items at a 0-8 scale
|
Baseline and 3 month follow-up
|
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NIAS: Nine Item Avoidant/Restrictive Food Intake disorder screen
Periodo de tiempo: 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
|
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Bodily Distress Syndrome Checklist (BDS Checklist; Budtz-Lilly et al., 2015)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
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Screening, baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
|
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Symptom Check List - Anxiety and Depression subscales (SCL-ANX &´SCL-DEP; Christensen et al., 2005; Derogatis, 1983)
Periodo de tiempo: Screening, baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
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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
|
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Questionnaire on healthcare consumption and productivity losses for patients with a psychiatric disorder (TiC-P; Bouwmans et al., 2013)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: end of treatment (i.e. after 10 weeks of treatment),
|
Self-perceived change, 1 items measured at 5 point scale (0-4)
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end of treatment (i.e. after 10 weeks of treatment),
|
|
Mind-wandering in daily life (Kane et al. 2007)
Periodo de tiempo: 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)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Expectation for counseling success (ECS; Kim et al., 2005)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline
|
3 items measured at 0-3 and 3 open-ended questions
|
Baseline
|
|
Working Alliance Inventory - Short Form (WAI-SF; Tracey & Kokotovic, 1989)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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),
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lisbeth Frostholm, Professor, Department for Functional Disorders, Aarhus University Hospital/Aarhus University
Publicaciones y enlaces útiles
Publicaciones Generales
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Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FGID pilot study
- ID: 147092 (Otro número de subvención/financiamiento: Trygfonden)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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