Back to resultsInternet-delivered CBT for Children With Functional Gastrointestinal Disorders - an Open Pilot Study
Primary Purpose
Functional Gastrointestinal Disorders
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-delivered CBT
Sponsored by
About this trial
This is an interventional treatment trial for Functional Gastrointestinal Disorders
Eligibility Criteria
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,
Sites / Locations
- Child and Adolescent Psychiatry in Stockholm
- Child and Adolescent Psychiatry in Stockholm
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Internet-delivered CBT
Arm Description
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.
Outcomes
Primary Outcome Measures
PedsQL Gastro
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.
Secondary Outcome Measures
Faces Pain Rating Scale. (FACES)
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.
Faces Pain Rating Scale. (FACES)
Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.
The Pain App
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.
Pediatric Quality of Life Inventory (PedsQL)
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.
Children´s Somatization Inventory (CSI 24)
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).
Functional Disability Index (FDI)
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.
Insomnia Severity Index (ISI)
Change in problematic sleeping patterns from baseline to 10 weeks, baseline to 9 months measured with a self-report scale that measures sleeping habits.
IBS-behavioral responses questionnaire (IBS-BRQ)
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.
Spence Children Anxiety Scale - short version (SCAS)
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.
Child Depression Inventory - short version (CDI-S)
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.
Pain Response Inventory (PRI) - subscale Coping
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.
Pressure Activation Stress Scale (PAS)
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.
Visceral Sensitivity Index (IBS-VSI)
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.
Client satisfactory questionnaire (CSQ)
Self-rating scale that measures satisfaction with treatment after completion.
Subjective Assessment Questionnaire (SAQ)
Self-rating scale that measures subjective change in symptoms as an effect of treatment.
PedsQL Gastro
Change in gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
IBS-behavioral responses questionnaire (IBS-BRQ)
Change in gastrointestinal symptoms-specific behavior measured with a self-rating scale weekly during treatment for mediation analyses.
ROME-III Questionnaire
Change in children's functional gastrointestinal disorders diagnostic status measured by ROME-III as a self-rating scale.
Adverse Events (AE)
Self-rating scale that measures adverse events related to treatment.
Generalized Anxiety Disorder Screener (GAD-7)
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.
Patient Health Questionnaire (PHQ 9)
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.
Adult Responses to Children's Symptoms (ARCS)
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.
Parental Behavior in Response to Children's Functional Gastrointestinal Disorders
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.
Parental Behavior in Response to Children's Functional Gastrointestinal Disorders
Change in parental behavior measured weekly with a self-report scale assessing common responses to children´s gastrointestinal symptoms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02475096
Brief Title
Internet-delivered CBT for Children With Functional Gastrointestinal Disorders - an Open Pilot Study
Official Title
Internet-delivered Cognitive Behavior Therapy for Children With Pain-predominant Functional Gastrointestinal Disorders - an Open Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Gastrointestinal Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (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 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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered CBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
PedsQL Gastro
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months
Secondary Outcome Measure Information:
Title
Faces Pain Rating Scale. (FACES)
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months
Title
Faces Pain Rating Scale. (FACES)
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
The Pain App
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months
Title
Pediatric Quality of Life Inventory (PedsQL)
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months
Title
Children´s Somatization Inventory (CSI 24)
Description
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).
Time Frame
Baseline to 10 weeks, baseline to 9 months
Title
Functional Disability Index (FDI)
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months
Title
Insomnia Severity Index (ISI)
Description
Change in problematic sleeping patterns from baseline to 10 weeks, baseline to 9 months measured with a self-report scale that measures sleeping habits.
Time Frame
Baseline to 10 weeks, baseline to 9 months
Title
IBS-behavioral responses questionnaire (IBS-BRQ)
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months
Title
Spence Children Anxiety Scale - short version (SCAS)
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months
Title
Child Depression Inventory - short version (CDI-S)
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months
Title
Pain Response Inventory (PRI) - subscale Coping
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months
Title
Pressure Activation Stress Scale (PAS)
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months
Title
Visceral Sensitivity Index (IBS-VSI)
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months
Title
Client satisfactory questionnaire (CSQ)
Description
Self-rating scale that measures satisfaction with treatment after completion.
Time Frame
At 10 weeks
Title
Subjective Assessment Questionnaire (SAQ)
Description
Self-rating scale that measures subjective change in symptoms as an effect of treatment.
Time Frame
At 10 weeks
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)
Title
IBS-behavioral responses questionnaire (IBS-BRQ)
Description
Change in gastrointestinal symptoms-specific behavior measured with a self-rating scale weekly during treatment for mediation analyses.
Time Frame
Weekly during treatment (treatment week 1-9)
Title
ROME-III Questionnaire
Description
Change in children's functional gastrointestinal disorders diagnostic status measured by ROME-III as a self-rating scale.
Time Frame
Baseline to 10 weeks, baseline to 9 months
Title
Adverse Events (AE)
Description
Self-rating scale that measures adverse events related to treatment.
Time Frame
At 10 weeks
Title
Generalized Anxiety Disorder Screener (GAD-7)
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months
Title
Patient Health Questionnaire (PHQ 9)
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months
Title
Adult Responses to Children's Symptoms (ARCS)
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months
Title
Parental Behavior in Response to Children's Functional Gastrointestinal Disorders
Description
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.
Time Frame
Baseline to 10 weeks, baseline to 9 months
Title
Parental Behavior in Response to Children's Functional Gastrointestinal Disorders
Description
Change in parental behavior measured weekly with a self-report scale assessing common responses to children´s gastrointestinal symptoms.
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 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,
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
State/Province
Stockholms lans landsting
ZIP/Postal Code
11330
Country
Sweden
Facility Name
Child and Adolescent Psychiatry in Stockholm
City
Stockholm
ZIP/Postal Code
11330
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Internet-delivered CBT for Children With Functional Gastrointestinal Disorders - an Open Pilot Study
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