NCT03252743

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

Internet-delivered Exposure-based Cognitive Behavior Therapy for Pain-predominant Functional Gastrointestinal Disorders in Children and Adolescents: an Implementation Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Functional Gastrointestinal Disorders
• Irritable Bowel Syndrome
• Dyspepsia
• Functional Abdominal Pain

Interventions

Type	Name	Description
BEHAVIORAL	Exposure-based internet-delivered CBT	The main target in treatment is exposure for abdominal symptoms by reducing avoidance and provoking symptoms. Participants are encouraged to gradually increase the difficulty by combining multiple challenges. The parents are taught how to reduce the risk for reinforcement of children's symptom behavior, and to support their child to complete the treatment. All treatment content is delivered over the internet, containing texts, videos, audio-files and examples. The modules are unlocked sequentially as participants worked their way through the treatment. Therapist support consists primarily of encouragement of any progress made in the treatment and support to find individual exercises.

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-06-17
• Completion: 2018-12-18
• First posted: 2017-08-17
• Last updated: 2019-02-26

Locations

1 site across 1 country: Sweden