- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02475096
Internet-delivered CBT for Children With Functional Gastrointestinal Disorders - an Open Pilot Study
Internet-delivered Cognitive Behavior Therapy for Children With Pain-predominant Functional Gastrointestinal Disorders - an Open Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Stockholm, Sweden, 11330
- Child and Adolescent Psychiatry in Stockholm
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Stockholms lans landsting
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Stockholm, Stockholms lans landsting, Sweden, 11330
- Child and Adolescent Psychiatry in Stockholm
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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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.
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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
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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.
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Baseline to 10 weeks, baseline to 9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Faces Pain Rating Scale. (FACES)
Time Frame: Baseline to 10 weeks, baseline to 9 months
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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.
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Baseline to 10 weeks, baseline to 9 months
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Faces Pain Rating Scale. (FACES)
Time Frame: Weekly during treatment (treatment week 1-9)
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Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.
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Weekly during treatment (treatment week 1-9)
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The Pain App
Time Frame: Baseline to 10 weeks, baseline to 9 months
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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.
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Baseline to 10 weeks, baseline to 9 months
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Pediatric Quality of Life Inventory (PedsQL)
Time Frame: Baseline to 10 weeks, baseline to 9 months
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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.
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Baseline to 10 weeks, baseline to 9 months
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Children´s Somatization Inventory (CSI 24)
Time Frame: Baseline to 10 weeks, baseline to 9 months
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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).
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Baseline to 10 weeks, baseline to 9 months
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Functional Disability Index (FDI)
Time Frame: Baseline to 10 weeks, baseline to 9 months
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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.
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Baseline to 10 weeks, baseline to 9 months
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Insomnia Severity Index (ISI)
Time Frame: Baseline to 10 weeks, baseline to 9 months
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Change in problematic sleeping patterns from baseline to 10 weeks, baseline to 9 months measured with a self-report scale that measures sleeping habits.
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Baseline to 10 weeks, baseline to 9 months
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IBS-behavioral responses questionnaire (IBS-BRQ)
Time Frame: Baseline to 10 weeks, baseline to 9 months
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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.
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Baseline to 10 weeks, baseline to 9 months
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Spence Children Anxiety Scale - short version (SCAS)
Time Frame: Baseline to 10 weeks, baseline to 9 months
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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.
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Baseline to 10 weeks, baseline to 9 months
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Child Depression Inventory - short version (CDI-S)
Time Frame: Baseline to 10 weeks, baseline to 9 months
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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.
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Baseline to 10 weeks, baseline to 9 months
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Pain Response Inventory (PRI) - subscale Coping
Time Frame: Baseline to 10 weeks, baseline to 9 months
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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.
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Baseline to 10 weeks, baseline to 9 months
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Pressure Activation Stress Scale (PAS)
Time Frame: Baseline to 10 weeks, baseline to 9 months
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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.
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Baseline to 10 weeks, baseline to 9 months
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Visceral Sensitivity Index (IBS-VSI)
Time Frame: Baseline to 10 weeks, baseline to 9 months
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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.
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Baseline to 10 weeks, baseline to 9 months
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Client satisfactory questionnaire (CSQ)
Time Frame: At 10 weeks
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Self-rating scale that measures satisfaction with treatment after completion.
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At 10 weeks
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Subjective Assessment Questionnaire (SAQ)
Time Frame: At 10 weeks
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Self-rating scale that measures subjective change in symptoms as an effect of treatment.
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At 10 weeks
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PedsQL Gastro
Time Frame: Weekly during treatment (treatment week 1-9)
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Change in gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
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Weekly during treatment (treatment week 1-9)
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IBS-behavioral responses questionnaire (IBS-BRQ)
Time Frame: Weekly during treatment (treatment week 1-9)
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Change in gastrointestinal symptoms-specific behavior measured with a self-rating scale weekly during treatment for mediation analyses.
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Weekly during treatment (treatment week 1-9)
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ROME-III Questionnaire
Time Frame: Baseline to 10 weeks, baseline to 9 months
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Change in children's functional gastrointestinal disorders diagnostic status measured by ROME-III as a self-rating scale.
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Baseline to 10 weeks, baseline to 9 months
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Adverse Events (AE)
Time Frame: At 10 weeks
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Self-rating scale that measures adverse events related to treatment.
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At 10 weeks
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Generalized Anxiety Disorder Screener (GAD-7)
Time Frame: Baseline to 10 weeks, baseline to 9 months
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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.
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Baseline to 10 weeks, baseline to 9 months
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Patient Health Questionnaire (PHQ 9)
Time Frame: Baseline to 10 weeks, baseline to 9 months
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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.
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Baseline to 10 weeks, baseline to 9 months
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Adult Responses to Children's Symptoms (ARCS)
Time Frame: Baseline to 10 weeks, baseline to 9 months
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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.
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Baseline to 10 weeks, baseline to 9 months
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Parental Behavior in Response to Children's Functional Gastrointestinal Disorders
Time Frame: Baseline to 10 weeks, baseline to 9 months
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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.
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Baseline to 10 weeks, baseline to 9 months
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Parental Behavior in Response to Children's Functional Gastrointestinal Disorders
Time Frame: Weekly during treatment (treatment week 1-9)
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Change in parental behavior measured weekly with a self-report scale assessing common responses to children´s gastrointestinal symptoms.
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Weekly during treatment (treatment week 1-9)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ola Olén, MD PhD, Karolinska Institutet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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