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

NCT02475096 | Completed

• 1 other identifier: Pilot child ICBT FGID
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• Faces Pain Rating Scale. (FACES)

  Baseline to 10 weeks, baseline to 9 months

• Faces Pain Rating Scale. (FACES)

  Weekly during treatment (treatment week 1-9)

• The Pain App

  Baseline to 10 weeks, baseline to 9 months

• Pediatric Quality of Life Inventory (PedsQL)

  Baseline to 10 weeks, baseline to 9 months

• Children´s Somatization Inventory (CSI 24)

  Baseline to 10 weeks, baseline to 9 months

Study Arms (1)

Internet-delivered CBT

EXPERIMENTAL

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.

Behavioral: Internet-delivered CBT

Interventions

Internet-delivered CBT BEHAVIORAL

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.

Internet-delivered CBT

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Simultaneous presence of serious somatic disease and / or if the child meets the criteria for other organic disease which better explains the symptoms.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (2)

Child and Adolescent Psychiatry in Stockholm

Stockholm, Stockholms Lans Landsting, 11330, Sweden

Location

Child and Adolescent Psychiatry in Stockholm

Stockholm, 11330, Sweden

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Ola Olén, MD PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD MD

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 18, 2015
• Study Start: July 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

SE (2)