Back to resultsInternet-Delivered CBT for Children With Functional Abdominal Pain Disorders
Primary Purpose
Functional Abdominal Pain Disorders
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-delivered Cognitive behavior therapy
Sponsored by
About this trial
This is an interventional treatment trial for Functional Abdominal Pain Disorders
Eligibility Criteria
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 %.
Sites / Locations
- Child and Adolescent Psychiatry in Stockholm
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Internet-delivered CBT
Waiting list
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Faces Pain Rating Scale
Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.
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.
Faces Pain Rating Scale rated by parents
Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.
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.
PedsQL Gastro rated by parents
Change in child gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation.
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.
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.
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.
Painfree days
Change in pain free days measured with a self-rating scale weekly during treatment for mediation analyses.
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.
Painfree days rated by parents
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)
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.
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.
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.
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.
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.
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.
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.
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.
Visceral Sensitivity Index
Change in visceral sensitivity measured with a self-rating scale weekly during treatment for mediation analyses.
Client Satisfactory Questionnaire (CSQ)
Client satisfaction rated measured with a self-rating scale
Client Satisfactory Questionnaire (CSQ) rated by parents
Client satisfaction rated measured with a self-rating scale
Subjective Assessment Questionnaire (SAQ)
Subjective change in symptoms measured with a self-rating scale
Subjective Assessment Questionnaire (SAQ) rated by parents
Subjective change in the child's symptoms measured with a self-rating scale by the parents.
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.
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.
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.
School absenteeism rated by parents
Change in child's school absenteeism measured with a self-rating scale weekly during treatment for mediation analyses.
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.
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.
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.
Adverse events (AE)
Adverse events during treatment measured with a self-rating scale by the parents.
Working Alliance Inventory (WAI) short version
Working alliance in first three weeks of treatment measured with a self-rating scale by the parents.
The treatment credibility scale rated by parents.
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
Costs associated with the disorder measured with a self-rating scale by the parents.
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.
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.
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.
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.
PedsQL Gastro
Change in gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Full Information
NCT ID
NCT02873078
First Posted
August 9, 2016
Last Updated
September 14, 2020
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT02873078
Brief Title
Internet-Delivered CBT for Children With Functional Abdominal Pain Disorders
Official Title
Internet-Delivered Cognitive Behavior Therapy for Children With Functional Abdominal Pain Disorders - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Abdominal Pain Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet-delivered CBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered Cognitive behavior therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
PedsQL Gastro
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Secondary Outcome Measure Information:
Title
Faces Pain Rating Scale
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
Faces Pain Rating Scale
Description
Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.
Time Frame
Weekly during treatment (treatment week 1-9).
Title
Faces Pain Rating Scale rated by parents
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
Faces Pain Rating Scale rated by parents
Description
Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.
Time Frame
Weekly during treatment (treatment week 1-9).
Title
PedsQL Gastro rated by parents
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
PedsQL Gastro rated by parents
Description
Change in child gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation.
Time Frame
Weekly during treatment (treatment week 1-9).
Title
Pediatric quality of life inventory (PedsQL QOL)
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
Pediatric quality of life inventory (PedsQL QOL) rated by parents
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
Painfree days
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
Painfree days
Description
Change in pain free days measured with a self-rating scale weekly during treatment for mediation analyses.
Time Frame
Weekly during treatment (treatment week 1-9)
Title
Painfree days rated by parents
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
Painfree days rated by parents
Description
Change in child's pain free days measured with a self-rating scale weekly during treatment for mediation analyses.
Time Frame
Weekly during treatment (treatment week 1-9)
Title
IBS-Behavioral responses questionnaire (IBS-BRQ)
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
IBS-Behavioral responses questionnaire (IBS-BRQ)
Description
Change in child's behavioral responses to abdominal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Time Frame
Weekly during treatment (treatment week 1-9)
Title
IBS-Behavioral responses questionnaire (IBS-BRQ) parental version
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
IBS-Behavioral responses questionnaire (IBS-BRQ) parental version
Description
Change in child's behavioral responses to abdominal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Time Frame
Weekly during treatment (treatment week 1-9)
Title
Spence Children Anxiety Scale - short version (SCAS-S)
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
Spence Children Anxiety Scale - short version (SCAS-S) rated by parents
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
Child Depression Inventory - short version (CDI-S)
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
Visceral Sensitivity Index
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
Visceral Sensitivity Index
Description
Change in visceral sensitivity measured with a self-rating scale weekly during treatment for mediation analyses.
Time Frame
Weekly during treatment (treatment week 1-9)
Title
Client Satisfactory Questionnaire (CSQ)
Description
Client satisfaction rated measured with a self-rating scale
Time Frame
At week 10
Title
Client Satisfactory Questionnaire (CSQ) rated by parents
Description
Client satisfaction rated measured with a self-rating scale
Time Frame
At week 10
Title
Subjective Assessment Questionnaire (SAQ)
Description
Subjective change in symptoms measured with a self-rating scale
Time Frame
At week 10
Title
Subjective Assessment Questionnaire (SAQ) rated by parents
Description
Subjective change in the child's symptoms measured with a self-rating scale by the parents.
Time Frame
At week 10
Title
Rome-IV questionnaire
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
Kidscreen
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
School absenteeism rated by parents
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
School absenteeism rated by parents
Description
Change in child's school absenteeism measured with a self-rating scale weekly during treatment for mediation analyses.
Time Frame
Weekly during treatment (treatment week 1-9)
Title
Pain Catastrophizing Scale, parental version (PCS-P)
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
Pain Catastrophizing Scale, parental version (PCS-P)
Description
Change in parental catastrophizing of the child's symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Time Frame
Weekly during treatment (treatment week 1-9)
Title
Children´s Somatization Inventory (CSI 24) rated by parents
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
Adverse events (AE)
Description
Adverse events during treatment measured with a self-rating scale by the parents.
Time Frame
At week 10
Title
Working Alliance Inventory (WAI) short version
Description
Working alliance in first three weeks of treatment measured with a self-rating scale by the parents.
Time Frame
At week 4
Title
The treatment credibility scale rated by parents.
Description
Treatment credibility measured with a self-rating scale by the parents.
Time Frame
At week 2
Title
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) rated by parents
Description
Costs associated with the disorder measured with a self-rating scale by the parents.
Time Frame
Baseline, at weeks 3, 7, 10 and at 9 months
Title
General health questionnaire (GHQ-12) rated by parents
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
Generalised anxiety disorder assessment (GAD 7) rated by parents
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
Adult responses to children's symptoms (ARCS) rated by parents
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Title
Adult responses to children's symptoms (ARCS) rated by parents
Description
Change in parental responses to child's symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Time Frame
Weekly during treatment (treatment week 1-9)
Title
PedsQL Gastro
Description
Change in gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Time Frame
Weekly during treatment (treatment week 1-9).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 %.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ola Olén, MD PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child and Adolescent Psychiatry in Stockholm
City
Stockholm
ZIP/Postal Code
11330
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30502501
Citation
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.
Results Reference
derived
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Internet-Delivered CBT for Children With Functional Abdominal Pain Disorders
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