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

Functional Gastrointestinal Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02475096
• Other study ID #: Pilot child ICBT FGID
• Status: Completed
• Phase: N/A
• First received: June 15, 2015
• Last updated: March 2, 2017
• Start date: July 2015
• Est. completion date: November 2016

Study information

• Verified date: March 2017
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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,

Related Conditions & MeSH terms

• Digestive System Diseases
• Disease
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

Behavioral:
• Internet-delivered CBT
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.

Locations

Country	Name	City	State
Sweden	Child and Adolescent Psychiatry in Stockholm	Stockholm	Stockholms lans landsting
Sweden	Child and Adolescent Psychiatry in Stockholm	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 10 weeks, baseline to 9 months
Secondary	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.	Baseline to 10 weeks, baseline to 9 months
Secondary	Faces Pain Rating Scale. (FACES)	Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.	Weekly during treatment (treatment week 1-9)
Secondary	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.	Baseline to 10 weeks, baseline to 9 months
Secondary	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.	Baseline to 10 weeks, baseline to 9 months
Secondary	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).	Baseline to 10 weeks, baseline to 9 months
Secondary	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.	Baseline to 10 weeks, baseline to 9 months
Secondary	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.	Baseline to 10 weeks, baseline to 9 months
Secondary	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.	Baseline to 10 weeks, baseline to 9 months
Secondary	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.	Baseline to 10 weeks, baseline to 9 months
Secondary	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.	Baseline to 10 weeks, baseline to 9 months
Secondary	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.	Baseline to 10 weeks, baseline to 9 months
Secondary	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.	Baseline to 10 weeks, baseline to 9 months
Secondary	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.	Baseline to 10 weeks, baseline to 9 months
Secondary	Client satisfactory questionnaire (CSQ)	Self-rating scale that measures satisfaction with treatment after completion.	At 10 weeks
Secondary	Subjective Assessment Questionnaire (SAQ)	Self-rating scale that measures subjective change in symptoms as an effect of treatment.	At 10 weeks
Secondary	PedsQL Gastro	Change in gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.	Weekly during treatment (treatment week 1-9)
Secondary	IBS-behavioral responses questionnaire (IBS-BRQ)	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)
Secondary	ROME-III Questionnaire	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
Secondary	Adverse Events (AE)	Self-rating scale that measures adverse events related to treatment.	At 10 weeks
Secondary	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.	Baseline to 10 weeks, baseline to 9 months
Secondary	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.	Baseline to 10 weeks, baseline to 9 months
Secondary	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.	Baseline to 10 weeks, baseline to 9 months
Secondary	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.	Baseline to 10 weeks, baseline to 9 months
Secondary	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.	Weekly during treatment (treatment week 1-9)