Internet-Delivered CBT for Children With Functional Abdominal Pain Disorders

September 14, 2020 updated by: Ola Olen, Karolinska Institutet

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
91

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PedsQL Gastro
Time Frame: 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.
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Faces Pain Rating Scale
Time Frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
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
Time Frame: Weekly during treatment (treatment week 1-9).
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
Time Frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
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
Time Frame: Weekly during treatment (treatment week 1-9).
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
Time Frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
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
Time Frame: Weekly during treatment (treatment week 1-9).
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)
Time Frame: 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.
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Pediatric quality of life inventory (PedsQL QOL) rated by parents
Time Frame: 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.
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Painfree days
Time Frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
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
Time Frame: Weekly during treatment (treatment week 1-9)
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
Time Frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
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
Time Frame: 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.
Weekly during treatment (treatment week 1-9)
IBS-Behavioral responses questionnaire (IBS-BRQ)
Time Frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
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)
Time Frame: 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.
Weekly during treatment (treatment week 1-9)
IBS-Behavioral responses questionnaire (IBS-BRQ) parental version
Time Frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
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
Time Frame: 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.
Weekly during treatment (treatment week 1-9)
Spence Children Anxiety Scale - short version (SCAS-S)
Time Frame: 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.
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Spence Children Anxiety Scale - short version (SCAS-S) rated by parents
Time Frame: 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.
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Child Depression Inventory - short version (CDI-S)
Time Frame: 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.
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Visceral Sensitivity Index
Time Frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
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
Time Frame: Weekly during treatment (treatment week 1-9)
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)
Time Frame: At week 10
Client satisfaction rated measured with a self-rating scale
At week 10
Client Satisfactory Questionnaire (CSQ) rated by parents
Time Frame: At week 10
Client satisfaction rated measured with a self-rating scale
At week 10
Subjective Assessment Questionnaire (SAQ)
Time Frame: At week 10
Subjective change in symptoms measured with a self-rating scale
At week 10
Subjective Assessment Questionnaire (SAQ) rated by parents
Time Frame: At week 10
Subjective change in the child's symptoms measured with a self-rating scale by the parents.
At week 10
Rome-IV questionnaire
Time Frame: 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.
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Kidscreen
Time Frame: 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.
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
School absenteeism rated by parents
Time Frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
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
Time Frame: 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.
Weekly during treatment (treatment week 1-9)
Pain Catastrophizing Scale, parental version (PCS-P)
Time Frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
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)
Time Frame: 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.
Weekly during treatment (treatment week 1-9)
Children´s Somatization Inventory (CSI 24) rated by parents
Time Frame: 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.
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Adverse events (AE)
Time Frame: At week 10
Adverse events during treatment measured with a self-rating scale by the parents.
At week 10
Working Alliance Inventory (WAI) short version
Time Frame: At week 4
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.
Time Frame: At week 2
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
Time Frame: Baseline, at weeks 3, 7, 10 and at 9 months
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
Time Frame: 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.
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Generalised anxiety disorder assessment (GAD 7) rated by parents
Time Frame: 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.
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Adult responses to children's symptoms (ARCS) rated by parents
Time Frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
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
Time Frame: 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.
Weekly during treatment (treatment week 1-9)
PedsQL Gastro
Time Frame: Weekly during treatment (treatment week 1-9).
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ola Olén, MD PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RCT ICBT FAPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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