Clinical trial NCT03252743: ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study.
Official title: Internet-delivered Exposure-based Cognitive Behavior Therapy for Pain-predominant Functional Gastrointestinal Disorders in Children and Adolescents: an Implementation Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Irritable Bowel Syndrome
Dyspepsia
Functional Abdominal Pain
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 68
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open trial without control group to test feasibility and evaluate preliminary effects.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
timeFrame: Baseline to 10 weeks.
Secondary outcomes:
measure: Pain intensity (Faces Pain rating scale)
timeFrame: Baseline to 10 weeks
measure: Pain intensity (Faces Pain rating scale)
timeFrame: Baseline to 5 months.
measure: Pain intensity (Faces Pain rating scale)
timeFrame: Baseline to 8 months.
measure: Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
timeFrame: Baseline to 5 months.
measure: Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
timeFrame: Baseline to 8 months.
measure: Gastrointestinal symptoms module (PedsQL Gastro)
timeFrame: Baseline to 10 weeks
measure: Gastrointestinal symptoms module (PedsQL Gastro)
timeFrame: Baseline to 5 months.
measure: Gastrointestinal symptoms module (PedsQL Gastro)
timeFrame: Baseline to 8 months.
measure: Fear for symptoms (Visceral sensitivity index)
timeFrame: Baseline to 10 weeks.
measure: Fear for symptoms (Visceral sensitivity index)
timeFrame: Baseline to 5 months.
measure: Fear for symptoms (Visceral sensitivity index)
timeFrame: Baseline to 8 months.
measure: Avoidant behavior (IBS-BRQ)
timeFrame: Baseline to 10 weeks
measure: Avoidant behavior (IBS-BRQ)
timeFrame: Baseline to 5 months.
measure: Avoidant behavior (IBS-BRQ)
timeFrame: Baseline to 8 months.
measure: Quality of life (PedsQL)
timeFrame: Baseline to 10 weeks.
measure: Quality of life (PedsQL)
timeFrame: Baseline to 5 months.
measure: Quality of life (PedsQL)
timeFrame: Baseline to 8 months.
Other outcomes:
measure: Parental responses to children´s symptom behavior (ARCS)
timeFrame: Baseline to 10 weeks.
measure: Parental responses to children´s symptom behavior (ARCS)
timeFrame: Baseline to 5 months.
measure: Parental responses to children´s symptom behavior (ARCS)
timeFrame: Baseline to 8 months.
Locations:
city: Stockholm
country: Sweden
facility: Department of Clinical Neuroscience, Karolinska Institutet
Study officials:
affiliation: Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
name: Marianne Bonnert, PhD
role: PRINCIPAL_INVESTIGATOR
References: