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

Not Applicable

Completed

• Conditions: Functional Gastrointestinal Disorders
• Interventions: Behavioral: Internet-delivered CBT

• Registration Number: NCT02475096
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-06-17
• Study First Posted: 2015-06-18
• Study Start: 2015-07
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

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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,

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Internet-delivered CBT	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.

Primary Outcome Measures

Name	Time	Method
PedsQL Gastro	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.

Secondary Outcome Measures

Name	Time	Method
Faces Pain Rating Scale. (FACES)	Weekly during treatment (treatment week 1-9)	Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.
Pressure Activation Stress Scale (PAS)	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.
Visceral Sensitivity Index (IBS-VSI)	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.
Adverse Events (AE)	At 10 weeks	Self-rating scale that measures adverse events related to treatment.
Pediatric Quality of Life Inventory (PedsQL)	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.
Patient Health Questionnaire (PHQ 9)	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.
Functional Disability Index (FDI)	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.
Insomnia Severity Index (ISI)	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.
Spence Children Anxiety Scale - short version (SCAS)	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.
Subjective Assessment Questionnaire (SAQ)	At 10 weeks	Self-rating scale that measures subjective change in symptoms as an effect of treatment.
The Pain App	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.
Children´s Somatization Inventory (CSI 24)	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).
Pain Response Inventory (PRI) - subscale Coping	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.
PedsQL Gastro	Weekly during treatment (treatment week 1-9)	Change in gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
ROME-III Questionnaire	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.
IBS-behavioral responses questionnaire (IBS-BRQ)	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.
Child Depression Inventory - short version (CDI-S)	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.
Client satisfactory questionnaire (CSQ)	At 10 weeks	Self-rating scale that measures satisfaction with treatment after completion.
Generalized Anxiety Disorder Screener (GAD-7)	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.
Adult Responses to Children's Symptoms (ARCS)	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.
Parental Behavior in Response to Children's Functional Gastrointestinal Disorders	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.

Trial Locations

Locations (1)

Child and Adolescent Psychiatry in Stockholm; 🇸🇪 Stockholm, Sweden