Internet-delivered CBT for Children With Functional Gastrointestinal Disorders - an Open Pilot Study

March 2, 2017 updated by: Ola Olen, Karolinska Institutet

Internet-delivered Cognitive Behavior Therapy for Children With Pain-predominant Functional Gastrointestinal Disorders - an Open Pilot Study

This pilot-study aims to evaluate the effect size and feasibility of internet-delivered cognitive behavior therapy (ICBT) for children (age 8-12 years) with pain-predominant functional gastrointestinal disorders (e.g. irritable bowel syndrome, functional abdominal pain and functional dyspepsia according to the Rome III criteria). The main component investigated in this study is exposure for gastrointestinal symptoms and for feared stimuli and situations. Children will participate along with one of their parents in the treatment. The parents will also receive specific modules with information on how to support their child in the treatment.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • 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

      • Stockholm, Sweden, 11330
        • Child and Adolescent Psychiatry in Stockholm
    • Stockholms lans landsting
      • Stockholm, Stockholms lans landsting, 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

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children between 8-12 years (until their 13th birthday) who have been diagnosed with any of the diagnoses irritable bowel syndrome, functional dyspepsia or functional abdominal pain according to the Rome III criteria.
  • Any psychopharmacological medication should be stable since 1 month.
  • Parents and children need to master Swedish, have access to a computer with internet access, and be willing to participate in 10 weeks of treatment with homework.

Exclusion Criteria:

  • Simultaneous presence of serious somatic disease and / or if the child meets the criteria for other organic disease which better explains the symptoms.
  • Psychiatric or social problems that are considered serious and in need of a more intense treatment than ICBT leads to exclusion. Children with higher school absenteeism than 40% will not be included. Neither will children who have an ongoing psychological treatment be included,

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet-delivered CBT
Children and parents will receive 10 weekly modules of internet-delivered CBT (Cognitive Behavior Therapy). Parents will also receive 10 weekly specific modules for parents. Main components in the modules directed at children and parents are exposure for symptoms, feared stimuli and situations. The parents modules contain information on how they can support their children in the treatment and is based on social learning theory. Therapist support is provided through written messages within the secure platform. Therapists are trained CBT-psychologists.

The treatment is based on an internet-delivered CBT-treatment for adults with IBS and on the adapted version for adolescents with functional gastrointestinal disorders. The protocol has been tested in an open face-to-face CBT study of children aged 8-12 years (n=20) with promising results.

Main component in the treatment is exposure for symptoms. The purpose of the treatment is to reduce fearful and anxious responses to symptoms and lessen avoidance of symptoms in the child, and to teach the parents how parental behavior can influence symptoms in children as well as how to support exposure. Detailed behaviour analysis is made for each individual and instruction is given on how to gradually expose to symptoms to lessen fear for symptoms and widen the behavioral repertoire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PedsQL Gastro
Time Frame: Baseline to 10 weeks, baseline to 9 months
Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 10 weeks, and from baseline to 9 months for analysis of effect.
Baseline to 10 weeks, baseline to 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Faces Pain Rating Scale. (FACES)
Time Frame: Baseline to 10 weeks, baseline to 9 months
Change in pain intensity measured with a self-rating scale daily during 2 weeks at baseline and daily during 2 weeks after 9 months for analysis of effect.The Faces Pain Scale is a self-report measure used to assess the intensity of children's pain. Faces have four faces representing least pain and most pain on equal intervals on a scale from 0-10. Its validity is supported by a strong positive correlation (r=0.93, N=76) with a visual analogue scale (VAS) measure in children aged 5-12 years. The metric for scoring (0-10) conforms closely to a linear interval scale.
Baseline to 10 weeks, baseline to 9 months
Faces Pain Rating Scale. (FACES)
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)
The Pain App
Time Frame: Baseline to 10 weeks, baseline to 9 months
Change in pain intensity and daily frequency reported daily during two weeks at baseline, after treatment and at 9 months with a mobile phone application developed by the research group.
Baseline to 10 weeks, baseline to 9 months
Pediatric Quality of Life Inventory (PedsQL)
Time Frame: Baseline to 10 weeks, baseline to 9 months
Change in quality of life from baseline to 10 weeks, baseline to 9 months measured with a self-report scale that measures quality of life in adolescents. PedsQL Generic Core scales is a 23-item scale ranging from 0 (never) to 4 (almost always). The PedsQL is shown to distinguish between healthy children and adolescents and pediatric patients with acute or chronic health conditions and demonstrate acceptable reliability and validity.
Baseline to 10 weeks, baseline to 9 months
Children´s Somatization Inventory (CSI 24)
Time Frame: Baseline to 10 weeks, baseline to 9 months
Change in inner symptoms from baseline to 10 weeks, baseline to 9 months, measured with a self-report scale that measures inner symptoms (e.g., headache, nausea, heart racing) that often, but not necessarily, occur in the absence of identified disease, in children and adolescents. CSI-24 is a 24-item scale ranging from ranging from 0 '(not at all) to 4 (a whole lot).
Baseline to 10 weeks, baseline to 9 months
Functional Disability Index (FDI)
Time Frame: Baseline to 10 weeks, baseline to 9 months
Change in school attendance from baseline to 10 weeks, baseline to 9 months measured with 2 items from a self-report scale that measures school attendance.
Baseline to 10 weeks, baseline to 9 months
Insomnia Severity Index (ISI)
Time Frame: Baseline to 10 weeks, baseline to 9 months
Change in problematic sleeping patterns from baseline to 10 weeks, baseline to 9 months measured with a self-report scale that measures sleeping habits.
Baseline to 10 weeks, baseline to 9 months
IBS-behavioral responses questionnaire (IBS-BRQ)
Time Frame: Baseline to 10 weeks, baseline to 9 months
Change in Gastrointestinal symptom-specific behaviors measured with a self-rating scale weekly during treatment for mediation analyses, and from baseline to 10 weeks, baseline to 9 months, for analysis of effect.
Baseline to 10 weeks, baseline to 9 months
Spence Children Anxiety Scale - short version (SCAS)
Time Frame: Baseline to 10 weeks, baseline to 9 months
Change in anxiety symptoms from baseline to 10 weeks, baseline to 9 months with a self-report scale that measures anxiety symptoms in children and adolescents.
Baseline to 10 weeks, baseline to 9 months
Child Depression Inventory - short version (CDI-S)
Time Frame: Baseline to 10 weeks, baseline to 9 months
Change in level of depression from baseline to 10 weeks and from baseline to 9 months measured with a self-report scale that measures depression in children and adolescents.
Baseline to 10 weeks, baseline to 9 months
Pain Response Inventory (PRI) - subscale Coping
Time Frame: Baseline to 10 weeks, baseline to 9 months
Change in pain coping from baseline to 10 weeks and from baseline to 9 months measured with a self-report scale that measures pain coping strategies.
Baseline to 10 weeks, baseline to 9 months
Pressure Activation Stress Scale (PAS)
Time Frame: Baseline to 10 weeks, baseline to 9 months
Change in stress levels från baseline to 10 weeks and från baseline to 9 months measured with a self-report scale that measures perceived stress. The PAS is developed for children and validated for the age group.
Baseline to 10 weeks, baseline to 9 months
Visceral Sensitivity Index (IBS-VSI)
Time Frame: Baseline to 10 weeks, baseline to 9 months
Change in visceral sensitivity from baseline to 10 weeks, baseline to 9 months measured with a self-report scale that measures gastrointestinal symptom-specific anxiety.
Baseline to 10 weeks, baseline to 9 months
Client satisfactory questionnaire (CSQ)
Time Frame: At 10 weeks
Self-rating scale that measures satisfaction with treatment after completion.
At 10 weeks
Subjective Assessment Questionnaire (SAQ)
Time Frame: At 10 weeks
Self-rating scale that measures subjective change in symptoms as an effect of treatment.
At 10 weeks
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)
IBS-behavioral responses questionnaire (IBS-BRQ)
Time Frame: Weekly during treatment (treatment week 1-9)
Change in gastrointestinal symptoms-specific behavior measured with a self-rating scale weekly during treatment for mediation analyses.
Weekly during treatment (treatment week 1-9)
ROME-III Questionnaire
Time Frame: Baseline to 10 weeks, baseline to 9 months
Change in children's functional gastrointestinal disorders diagnostic status measured by ROME-III as a self-rating scale.
Baseline to 10 weeks, baseline to 9 months
Adverse Events (AE)
Time Frame: At 10 weeks
Self-rating scale that measures adverse events related to treatment.
At 10 weeks
Generalized Anxiety Disorder Screener (GAD-7)
Time Frame: Baseline to 10 weeks, baseline to 9 months
Change in anxiety levels in parents from baseline to 10 weeks, baseline to 9 months measured with a self-report scale that measures anxiety symptoms. GAD-7 is a 7-item scale ranging from 0 (not at all) to 3 (almost every day). Evidence supports reliability and validity of the GAD-7 as a measure of anxiety in the general population.
Baseline to 10 weeks, baseline to 9 months
Patient Health Questionnaire (PHQ 9)
Time Frame: Baseline to 10 weeks, baseline to 9 months
Change in depression levels in parents from baseline to 10 weeks, baseline to 9 months measured with a self-report scale that measures depression. PHQ-9 is shown to be a reliable and valid measure of depression severity in adults.
Baseline to 10 weeks, baseline to 9 months
Adult Responses to Children's Symptoms (ARCS)
Time Frame: Baseline to 10 weeks, baseline to 9 months
Change in parents responses to their children's abdominal pain from baseline to 10 weeks, baseline to 9 months measured with a self-report scale assessing protectiveness, minimizing, and encouraging responses to children's pain behavior.
Baseline to 10 weeks, baseline to 9 months
Parental Behavior in Response to Children's Functional Gastrointestinal Disorders
Time Frame: Baseline to 10 weeks, baseline to 9 months
Change in parental behavior from baseline to 10 weeks, baseline to 9 months measured with a self-report scale assessing common responses to children´s gastrointestinal symptoms.
Baseline to 10 weeks, baseline to 9 months
Parental Behavior in Response to Children's Functional Gastrointestinal Disorders
Time Frame: Weekly during treatment (treatment week 1-9)
Change in parental behavior measured weekly with a self-report scale assessing common responses to children´s gastrointestinal symptoms.
Weekly during treatment (treatment week 1-9)

Collaborators and Investigators

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

Investigators

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

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 (Actual)

July 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

June 17, 2015

First Posted (Estimate)

June 18, 2015

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pilot child ICBT FGID

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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