Internet-delivered Cognitive Behavior Therapy for Children With Pain-predominant Functional Gastrointestinal Disorders - an Open Pilot Study

Karolinska Institutet1 site in 1 country31 target enrollmentJuly 2015

ConditionsFunctional Gastrointestinal Disorders

Overview

Phase: N/A
Intervention: Not specified
Conditions: Functional Gastrointestinal Disorders
Sponsor: Karolinska Institutet
Enrollment: 31
Locations: 1
Primary Endpoint: PedsQL Gastro
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

November 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Karolinska Institutet

Responsible Party

Principal Investigator

Ola Olen

PhD MD

Karolinska Institutet

Eligibility Criteria

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,

Outcomes

Primary Outcomes

PedsQL Gastro

Time Frame: Baseline to 10 weeks, baseline to 9 months

Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 10 weeks, and from baseline to 9 months for analysis of effect.

Secondary Outcomes

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