ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study.

Not Applicable

Completed

• Conditions: Dyspepsia; Functional Gastrointestinal Disorders; Functional Abdominal Pain; Irritable Bowel Syndrome
• Interventions: Behavioral: Exposure-based internet-delivered CBT

• Registration Number: NCT03252743
• Lead Sponsor: Karolinska Institutet

Brief Summary

This open trial aims to evaluate feasibility and preliminary effectiveness of an internet-delivered CBT-program for children and adolescents with functional gastrointestinal disorders when implemented in regular care.

Detailed Description

Pain predominant functional gastrointestinal disorders (P-FGIDs) are common in children and adolescents and associated with impaired quality of life. Our research group have previously in a series of efficacy-studies shown that internet-delivered exposure-based CBT leads to reduced symptoms and increased quality of life in children and adolescents with P-FGIDs. There is therefore reason to investigate how the treatment should be disseminated in regular care. This open trial aim to evaluate feasibility and preliminary treatment effects in regular care of the internet-delivered CBT-program for children and adolescents with P-FGIDs.

Method: Open trial with a pretest-posttest-design and no control group. The internet-delivered CBT-program is 10 week long and include weekly therapist support, consisting of online messages and telephone calls. Assessment points are baseline, weekly during treatment, post-treatment and follow-up at 3 months and 6 months after treatment completion.

Analysis: Effect sizes and within-group differences will be calculated in an intent-to-treat analysis using Cohens' d and Student's t-test.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-14
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-17
• Study Start: 2017-09-01
• Primary Completion: 2018-06-17
• Study Completion: 2018-12-18
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Age 8-17 at date of inclusion.
• Fulfilling Rome IV-criteria for irritable bowel syndrome, functional dyspepsia or functional abdominal pain with a written statement from patient's physician confirming a diagnosis.
• Stable psychotropic medication for at least 1 month.

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Exclusion Criteria

• concurrent serious medical conditions.
• a psychiatric diagnosis, judged to be a more important treatment target than the abdominal pain.
• on-going structured psychological treatment.
• absence from school exceeding an average of 2 days a week the last month is a cause for exclusion since high school absence demands more intensive interventions than can be offered in ICBT.
• on-going abuse or severe parental psychiatric illness in the family.
• since treatment format assumes normal reading and writing skills, pronounced language skill deficits and learning difficulties lead to exclusion from the study.
• lack of regular internet-access.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Internet-delivered CBT	Exposure-based internet-delivered CBT	Exposure-based internet-delivered CBT with ten weekly modules distributed over the internet during ten weeks, and weekly therapist support over the internet.

Primary Outcome Measures

Name	Time	Method
Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).	Baseline to 10 weeks.	Change in global gastrointestinal symptoms from baseline to 10 weeks.

Secondary Outcome Measures

Name	Time	Method
Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).	Baseline to 8 months.	Change in global gastrointestinal symptoms from baseline to 6 months follow-up.
Gastrointestinal symptoms module (PedsQL Gastro)	Baseline to 8 months.	Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 6 months follow up.
Fear for symptoms (Visceral sensitivity index)	Baseline to 8 months.	Change in fear for symptoms from baseline to 6 months follow-up.
Avoidant behavior (IBS-BRQ)	Baseline to 8 months.	Change in avoidant behavior from baseline to 6 months follow-up.
Quality of life (PedsQL)	Baseline to 8 months.	Change in quality of life from baseline to 6 months follow-up.
Pain intensity (Faces Pain rating scale)	Baseline to 8 months.	Change in pain intensity from baseline to 6 months follow-up.

Trial Locations

Locations (1)

Department of Clinical Neuroscience, Karolinska Institutet; 🇸🇪 Stockholm, Sweden