Clinical trial NCT02475096: 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
Overall status: COMPLETED
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-06-18
Enrollment: 31
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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,

Primary outcomes:
measure: PedsQL Gastro
timeFrame: Baseline to 10 weeks, baseline to 9 months
Secondary outcomes:
measure: Faces Pain Rating Scale. (FACES)
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: Faces Pain Rating Scale. (FACES)
timeFrame: Weekly during treatment (treatment week 1-9)
measure: The Pain App
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: Children´s Somatization Inventory (CSI 24)
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: Functional Disability Index (FDI)
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: IBS-behavioral responses questionnaire (IBS-BRQ)
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: Spence Children Anxiety Scale - short version (SCAS)
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: Child Depression Inventory - short version (CDI-S)
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: Pain Response Inventory (PRI) - subscale Coping
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: Pressure Activation Stress Scale (PAS)
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: Visceral Sensitivity Index (IBS-VSI)
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: Client satisfactory questionnaire (CSQ)
timeFrame: At 10 weeks
measure: Subjective Assessment Questionnaire (SAQ)
timeFrame: At 10 weeks
measure: PedsQL Gastro
timeFrame: Weekly during treatment (treatment week 1-9)
measure: IBS-behavioral responses questionnaire (IBS-BRQ)
timeFrame: Weekly during treatment (treatment week 1-9)
measure: ROME-III Questionnaire
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: Adverse Events (AE)
timeFrame: At 10 weeks
measure: Generalized Anxiety Disorder Screener (GAD-7)
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: Patient Health Questionnaire (PHQ 9)
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: Adult Responses to Children's Symptoms (ARCS)
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: Parental Behavior in Response to Children's Functional Gastrointestinal Disorders
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: Parental Behavior in Response to Children's Functional Gastrointestinal Disorders
timeFrame: Weekly during treatment (treatment week 1-9)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Child and Adolescent Psychiatry in Stockholm
state: Stockholms lans landsting
city: Stockholm
country: Sweden
facility: Child and Adolescent Psychiatry in Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Ola Olén, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: