Internet-Delivered CBT for Children With Functional Abdominal Pain Disorders

Internet-Delivered Cognitive Behavior Therapy for Children With Functional Abdominal Pain Disorders - a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Functional Abdominal Pain Disorders
• Intervention / Treatment: Behavioral: Internet-delivered Cognitive behavior therapy

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11330
    • Child and Adolescent Psychiatry in Stockholm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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 %.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-delivered CBT; 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.	Behavioral: Internet-delivered Cognitive behavior therapy; The treatment is delivered via an online platform and is based on interventions for adults, adolescents and children tested in previous trials. Therapists are CBT-psychologists och students in clinical psychology under supervision.
No Intervention: Waiting list; This is a wait-list control where the children and parents are allowed to carry on with any contacts within the health-care system, exempt for psychological treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PedsQL Gastro	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.	Baseline to 10 weeks, baseline to 9 months, baseline to 15 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Ola Olén, MD PhD, Karolinska Institutet

Publications and helpful links

General Publications

• Lalouni M, Ljotsson B, Bonnert M, Ssegonja R, Benninga M, Bjureberg J, Hogstrom J, Sahlin H, Simren M, Feldman I, Hedman-Lagerlof E, Serlachius E, Olen O. Clinical and Cost Effectiveness of Online Cognitive Behavioral Therapy in Children With Functional Abdominal Pain Disorders. Clin Gastroenterol Hepatol. 2019 Oct;17(11):2236-2244.e11. doi: 10.1016/j.cgh.2018.11.043. Epub 2018 Nov 28.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: August 9, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Somatoform Disorders
• Other Study ID Numbers: RCT ICBT FAPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO