Skip to main content
OpenTrials
Completed

NCT Number: NCT02873078

Internet-Delivered CBT for Children With Functional Abdominal Pain Disorders

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Functional Abdominal Pain Disorders

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child and Adolescent Psychiatry in Stockholm

Stockholm, 11330, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 %.

Treatment and study plan

Internet-delivered Cognitive Behavior Therapy

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. Client Satisfactory Questionnaire (CSQ)

    Time frame: At week 10

    Client satisfaction rated measured with a self-rating scale

  23. Client Satisfactory Questionnaire (CSQ) rated by parents

    Time frame: At week 10

    Client satisfaction rated measured with a self-rating scale

  24. Subjective Assessment Questionnaire (SAQ)

    Time frame: At week 10

    Subjective change in symptoms measured with a self-rating scale

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. Adverse events (AE)

    Time frame: At week 10

    Adverse events during treatment measured with a self-rating scale by the parents.

  34. 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.

  35. The treatment credibility scale rated by parents.

    Time frame: At week 2

    Treatment credibility measured with a self-rating scale by the parents.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 19, 2016
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.