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

Karolinska Institute

Status: Completed

Conditions: Irritable Bowel Syndrome; Functional Gastrointestinal Disorders; Functional Abdominal Pain; Dyspepsia

Treatments: Behavioral: Exposure-based internet-delivered CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT03252743

FGID IMP 2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

68 participants in 1 patient group

Internet-delivered CBT

Experimental group

Description:

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

Treatment:

Behavioral: Exposure-based internet-delivered CBT