Internet-Delivered CBT for Children With Functional Abdominal Pain Disorders

Not Applicable

Completed

• Conditions: Functional Abdominal Pain Disorders
• Interventions: Behavioral: Internet-delivered Cognitive behavior therapy

• Registration Number: NCT02873078
• Lead Sponsor: Karolinska Institutet

Brief Summary

This randomized controlled study aims to evaluate the efficacy of exposure-based Internet-delivered cognitive behavior therapy for children 8-12 years with Functional Abdominal Pain Disorders. The children participate along with their parents, who will also receive specific modules with information on how to support their children in the treatment. Predictors and mediators for treatment effects will be studied as well as the cost effectiveness of the intervention.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Children 8-12 years with either irritable bowel syndrome, functional dyspepsia or functional abdominal pain - not otherwise specified diagnosed according to Rome-III or Rome-IV criteria.
• Psychopharmacological medication stable for at least a month if medicating.
• Child and at least one parent speaking and writing swedish.
• Access to computer with Internet connection.

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Exclusion Criteria

• Severe somatic disorder and/or if the child fulfills criteria of other disorder that better explains the abdominal symptoms.
• Severe psychiatric or social problems that needs other care.
• Ongoing psychological treatment.
• School absenteeism more than 40 %.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet-delivered CBT	Internet-delivered Cognitive behavior therapy	Children and parents will receive 10 weekly modules of cognitive behavior therapy (CBT). Parents will also receive 10 weekly modules. Main components in the children's modules are exposure for abdominal symptoms, feared stimuli and situations in which the children are afraid of having symptoms. The parental receive information on how they can support their children in the treatment and how to reinforce health y behaviors and decrease attention to pain behaviors. Therapist support is provided through written messages within the secure platform.

Primary Outcome Measures

Name	Time	Method
PedsQL Gastro	Baseline to 10 weeks, baseline to 9 months, baseline to 15 months	Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.

Secondary Outcome Measures

Name	Time	Method
Faces Pain Rating Scale	Weekly during treatment (treatment week 1-9).	Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.
Faces Pain Rating Scale rated by parents	Weekly during treatment (treatment week 1-9).	Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.
PedsQL Gastro rated by parents	Weekly during treatment (treatment week 1-9).	Change in child gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation.
Pediatric quality of life inventory (PedsQL QOL)	Baseline to 10 weeks, baseline to 9 months, baseline to 15 months	Change in quality of life measured measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Pediatric quality of life inventory (PedsQL QOL) rated by parents	Baseline to 10 weeks, baseline to 9 months, baseline to 15 months	Change in child quality of life measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Painfree days	Weekly during treatment (treatment week 1-9)	Change in pain free days measured with a self-rating scale weekly during treatment for mediation analyses.
Painfree days rated by parents	Weekly during treatment (treatment week 1-9)	Change in child's pain free days measured with a self-rating scale weekly during treatment for mediation analyses.
IBS-Behavioral responses questionnaire (IBS-BRQ)	Weekly during treatment (treatment week 1-9)	Change in child's behavioral responses to abdominal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Spence Children Anxiety Scale - short version (SCAS-S) rated by parents	Baseline to 10 weeks, baseline to 9 months, baseline to 15 months	Change in child's anxiety symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Visceral Sensitivity Index	Weekly during treatment (treatment week 1-9)	Change in visceral sensitivity measured with a self-rating scale weekly during treatment for mediation analyses.
IBS-Behavioral responses questionnaire (IBS-BRQ) parental version	Weekly during treatment (treatment week 1-9)	Change in child's behavioral responses to abdominal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Spence Children Anxiety Scale - short version (SCAS-S)	Baseline to 10 weeks, baseline to 9 months, baseline to 15 months	Change in child's anxiety symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Adverse events (AE)	At week 10	Adverse events during treatment measured with a self-rating scale by the parents.
Child Depression Inventory - short version (CDI-S)	Baseline to 10 weeks, baseline to 9 months, baseline to 15 months	Change in child's depressive symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Client Satisfactory Questionnaire (CSQ)	At week 10	Client satisfaction rated measured with a self-rating scale
Rome-IV questionnaire	Baseline to 10 weeks, baseline to 9 months, baseline to 15 months	Change in diagnostic status of functional abdominal pain disorder measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Client Satisfactory Questionnaire (CSQ) rated by parents	At week 10	Client satisfaction rated measured with a self-rating scale
Subjective Assessment Questionnaire (SAQ)	At week 10	Subjective change in symptoms measured with a self-rating scale
Subjective Assessment Questionnaire (SAQ) rated by parents	At week 10	Subjective change in the child's symptoms measured with a self-rating scale by the parents.
Kidscreen	Baseline to 10 weeks, baseline to 9 months, baseline to 15 months	Change in quality of life for use in economic evaluation measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
School absenteeism rated by parents	Weekly during treatment (treatment week 1-9)	Change in child's school absenteeism measured with a self-rating scale weekly during treatment for mediation analyses.
Working Alliance Inventory (WAI) short version	At week 4	Working alliance in first three weeks of treatment measured with a self-rating scale by the parents.
The treatment credibility scale rated by parents.	At week 2	Treatment credibility measured with a self-rating scale by the parents.
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) rated by parents	Baseline, at weeks 3, 7, 10 and at 9 months	Costs associated with the disorder measured with a self-rating scale by the parents.
General health questionnaire (GHQ-12) rated by parents	Baseline to 10 weeks, baseline to 9 months, baseline to 15 months	Change in general health measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Generalised anxiety disorder assessment (GAD 7) rated by parents	Baseline to 10 weeks, baseline to 9 months, baseline to 15 months	Change in parental anxiety symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Pain Catastrophizing Scale, parental version (PCS-P)	Weekly during treatment (treatment week 1-9)	Change in parental catastrophizing of the child's symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Children´s Somatization Inventory (CSI 24) rated by parents	Baseline to 10 weeks, baseline to 9 months, baseline to 15 months	Change in child's somatization symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Adult responses to children's symptoms (ARCS) rated by parents	Weekly during treatment (treatment week 1-9)	Change in parental responses to child's symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
PedsQL Gastro	Weekly during treatment (treatment week 1-9).	Change in gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.

Trial Locations

Locations (1)

Child and Adolescent Psychiatry in Stockholm; 🇸🇪 Stockholm, Sweden