Overview

This trial is active, not recruiting.

Condition functional gastrointestinal disorders
Treatment internet-delivered cbt
Sponsor Karolinska Institutet
Start date July 2015
End date November 2016
Trial size 30 participants
Trial identifier NCT02475096, Pilot child ICBT FGID

Summary

This pilot-study aims to evaluate the effect size and feasibility of internet-delivered cognitive behavior therapy (ICBT) for children (age 8-12 years) with pain-predominant functional gastrointestinal disorders (e.g. irritable bowel syndrome, functional abdominal pain and functional dyspepsia according to the Rome III criteria). The main component investigated in this study is exposure for gastrointestinal symptoms and for feared stimuli and situations. Children will participate along with one of their parents in the treatment. The parents will also receive specific modules with information on how to support their child in the treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Children and parents will receive 10 weekly modules of internet-delivered CBT (Cognitive Behavior Therapy). Parents will also receive 10 weekly specific modules for parents. Main components in the modules directed at children and parents are exposure for symptoms, feared stimuli and situations. The parents modules contain information on how they can support their children in the treatment and is based on social learning theory. Therapist support is provided through written messages within the secure platform. Therapists are trained CBT-psychologists.
internet-delivered cbt
The treatment is based on an internet-delivered CBT-treatment for adults with IBS and on the adapted version for adolescents with functional gastrointestinal disorders. The protocol has been tested in an open face-to-face CBT study of children aged 8-12 years (n=20) with promising results. Main component in the treatment is exposure for symptoms. The purpose of the treatment is to reduce fearful and anxious responses to symptoms and lessen avoidance of symptoms in the child, and to teach the parents how parental behavior can influence symptoms in children as well as how to support exposure. Detailed behaviour analysis is made for each individual and instruction is given on how to gradually expose to symptoms to lessen fear for symptoms and widen the behavioral repertoire.

Primary Outcomes

Measure
PedsQL Gastro
time frame: Baseline to 10 weeks, baseline to 9 months

Secondary Outcomes

Measure
Faces Pain Rating Scale. (FACES)
time frame: Baseline to 10 weeks, baseline to 9 months
Faces Pain Rating Scale. (FACES)
time frame: Weekly during treatment (treatment week 1-9)
The Pain App
time frame: Baseline to 10 weeks, baseline to 9 months
Pediatric Quality of Life Inventory (PedsQL)
time frame: Baseline to 10 weeks, baseline to 9 months
Children´s Somatization Inventory (CSI 24)
time frame: Baseline to 10 weeks, baseline to 9 months
Functional Disability Index (FDI)
time frame: Baseline to 10 weeks, baseline to 9 months
Insomnia Severity Index (ISI)
time frame: Baseline to 10 weeks, baseline to 9 months
IBS-behavioral responses questionnaire (IBS-BRQ)
time frame: Baseline to 10 weeks, baseline to 9 months
Spence Children Anxiety Scale - short version (SCAS)
time frame: Baseline to 10 weeks, baseline to 9 months
Child Depression Inventory - short version (CDI-S)
time frame: Baseline to 10 weeks, baseline to 9 months
Pain Response Inventory (PRI) - subscale Coping
time frame: Baseline to 10 weeks, baseline to 9 months
Pressure Activation Stress Scale (PAS)
time frame: Baseline to 10 weeks, baseline to 9 months
Visceral Sensitivity Index (IBS-VSI)
time frame: Baseline to 10 weeks, baseline to 9 months
Client satisfactory questionnaire (CSQ)
time frame: At 10 weeks
Subjective Assessment Questionnaire (SAQ)
time frame: At 10 weeks
PedsQL Gastro
time frame: Weekly during treatment (treatment week 1-9)
IBS-behavioral responses questionnaire (IBS-BRQ)
time frame: Weekly during treatment (treatment week 1-9)
ROME-III Questionnaire
time frame: Baseline to 10 weeks, baseline to 9 months
Adverse Events (AE)
time frame: At 10 weeks
Generalized Anxiety Disorder Screener (GAD-7)
time frame: Baseline to 10 weeks, baseline to 9 months
Patient Health Questionnaire (PHQ 9)
time frame: Baseline to 10 weeks, baseline to 9 months
Adult Responses to Children's Symptoms (ARCS)
time frame: Baseline to 10 weeks, baseline to 9 months
Parental Behavior in Response to Children's Functional Gastrointestinal Disorders
time frame: Baseline to 10 weeks, baseline to 9 months
Parental Behavior in Response to Children's Functional Gastrointestinal Disorders
time frame: Weekly during treatment (treatment week 1-9)

Eligibility Criteria

Male or female participants from 8 years up to 12 years old.

Inclusion Criteria: - Children between 8-12 years (until their 13th birthday) who have been diagnosed with any of the diagnoses irritable bowel syndrome, functional dyspepsia or functional abdominal pain according to the Rome III criteria. - Any psychopharmacological medication should be stable since 1 month. - Parents and children need to master Swedish, have access to a computer with internet access, and be willing to participate in 10 weeks of treatment with homework. Exclusion Criteria: - Simultaneous presence of serious somatic disease and / or if the child meets the criteria for other organic disease which better explains the symptoms. - Psychiatric or social problems that are considered serious and in need of a more intense treatment than ICBT leads to exclusion. Children with higher school absenteeism than 40% will not be included. Neither will children who have an ongoing psychological treatment be included,

Additional Information

Official title Internet-delivered Cognitive Behavior Therapy for Children With Pain-predominant Functional Gastrointestinal Disorders - an Open Pilot Study
Principal investigator Ola Olén, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Karolinska Institutet.