Internet-delivered Exposure-based Cognitive Behavior Therapy for Pain-predominant Functional Gastrointestinal Disorders in Children and Adolescents: an Implementation Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Exposure-based internet-delivered CBT (Behavioral)
Outcomes
Primary Outcomes
Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
Time Frame: Baseline to 10 weeks.
Change in global gastrointestinal symptoms from baseline to 10 weeks.
Secondary Outcomes
- Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).(Baseline to 8 months.)
- Gastrointestinal symptoms module (PedsQL Gastro)(Baseline to 8 months.)
- Fear for symptoms (Visceral sensitivity index)(Baseline to 8 months.)
- Avoidant behavior (IBS-BRQ)(Baseline to 8 months.)
- Quality of life (PedsQL)(Baseline to 8 months.)
- Pain intensity (Faces Pain rating scale)(Baseline to 8 months.)
- Pain intensity (Faces Pain rating scale)(Baseline to 10 weeks)
- Pain intensity (Faces Pain rating scale)(Baseline to 5 months.)
- Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).(Baseline to 5 months.)
- Gastrointestinal symptoms module (PedsQL Gastro)(Baseline to 10 weeks)
- Gastrointestinal symptoms module (PedsQL Gastro)(Baseline to 5 months.)
- Fear for symptoms (Visceral sensitivity index)(Baseline to 10 weeks.)
- Fear for symptoms (Visceral sensitivity index)(Baseline to 5 months.)
- Avoidant behavior (IBS-BRQ)(Baseline to 10 weeks)
- Avoidant behavior (IBS-BRQ)(Baseline to 5 months.)
- Quality of life (PedsQL)(Baseline to 10 weeks.)
- Quality of life (PedsQL)(Baseline to 5 months.)
Investigators
Marianne Bonnert
PhD
Karolinska Institutet