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

Karolinska Institutet68 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Functional Gastrointestinal Disorders Irritable Bowel Syndrome Dyspepsia Functional Abdominal Pain

Interventions

Exposure-based internet-delivered CBTBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Clinical Neuroscience, Karolinska Institutet

Stockholm, Sweden

Outcomes

Primary Outcomes

Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).

Change in global gastrointestinal symptoms from baseline to 10 weeks.

Time frame: Baseline to 10 weeks.

Secondary Outcomes

Pain intensity (Faces Pain rating scale)

Change in pain intensity from baseline to 10 weeks

Time frame: Baseline to 10 weeks

Pain intensity (Faces Pain rating scale)

Change in pain intensity from baseline to 3 months follow-up.

Time frame: Baseline to 5 months.

Pain intensity (Faces Pain rating scale)

Change in pain intensity from baseline to 6 months follow-up.

Time frame: Baseline to 8 months.

Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).

Change in global gastrointestinal symptoms from baseline to 3 months follow-up.

Time frame: Baseline to 5 months.

Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).

Change in global gastrointestinal symptoms from baseline to 6 months follow-up.

Time frame: Baseline to 8 months.

Gastrointestinal symptoms module (PedsQL Gastro)

Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 10 weeks.

Time frame: Baseline to 10 weeks

Gastrointestinal symptoms module (PedsQL Gastro)

Data from ClinicalTrials.gov

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