NCT02113605

Brief Summary

The purpose of the trial is to develop a treatment protocol to be used in trials studying internet-delivered CBT for children with functional gastrointestinal disorders (FGID). The study size is not based on power calculations but the estimated sample necessary to develop a treatment protocol. This study will include 20-30 children with FGID and their parents who will be treated individually (face-to-face). The treatment consists of 10 weekly sessions of exposure-based CBT. The study uses a pre- post-design with no control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

1.6 years

First QC Date

April 1, 2014

Last Update Submit

December 1, 2015

Conditions

Functional Gastrointestinal Disorders (FGID)FGID According to the Rome III CriteriaIrritable Bowel Syndrome (IBS)Functional Abdominal PainFunctional Dyspepsia

Keywords

Functional gastrointestinal disordersFGIDRecurrent abdominal painAbdominal painpain-predominant functional gastrointestinal disordersPediatric pain

Outcome Measures

Primary Outcomes (2)

  • Change in Faces Pain Rating Scale (FACES) from baseline to 10 weeks

    Baseline and 10 weeks

  • Change in Faces Pain Rating Scale (FACES) from baseline to 8 months.

    Baseline and 8 months.

Secondary Outcomes (20)

  • Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 10 weeks.

    Baseline and 10 weeks.

  • Change in Children´s Somatization Inventory (CSI 24) from baseline to 10 weeks

    Baseline and 10 weeks.

  • Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 10 weeks

    Baseline and 10 weeks.

  • Change in Functional Disability Index (FDI) from baseline to 10 weeks.

    Baseline and 10 weeks.

  • Change in Pain Reactivity Scale from baseline to 10 weeks.

    Baseline and 10 weeks.

  • +15 more secondary outcomes

Other Outcomes (4)

  • Change in Parental Behavior FGID (PB-FGID) from baseline to 10 weeks.

    Baseline and 10 weeks.

  • Change in Parental Behavior FGID (PB-FGID) from baseline to 8 months.

    Baseline and 8 months.

  • Change in Adult responses to children´s symptoms (ARCS) from baseline to 10 weeks.

    Baseline and 10 weeks.

  • +1 more other outcomes

Study Arms (1)

Cognitive behavior therapy

EXPERIMENTAL

All included children are treated with a face-to-face exposure-based cognitive behaviour therapy for 10 weeks. There will be no comparison arm.

Other: Cognitive behavior therapy

Interventions

Cognitive behavior therapyOTHER

Exposure-based cognitive behavior therapy in a 10 week face-to-face treatment

Cognitive behavior therapy

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age between 8-12 years
  • A diagnosis of a functional gastrointestinal disorder by a treating physician

You may not qualify if:

  • Concurrent serious medical condition or gastrointestinal symptoms likely caused by an organic disorder.
  • Psychiatric disorder more urgent to treat than the abdominal pain.
  • On-going psychological treatment.
  • Absence from school more than 40 %.
  • Ongoing maltreatment, violence or severe parental psychiatric illness.
  • Pronounced language or learning difficulties that hinder the child to benefit from the treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child and Adolescent Psychiatry in Stockholm

Stockholm, 11330, Sweden

Location

MeSH Terms

Conditions

Gastrointestinal DiseasesIrritable Bowel SyndromeAbdominal Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Digestive System DiseasesColonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

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
MD, PhD

Study Record Dates

First Submitted

April 1, 2014

First Posted

April 14, 2014

Study Start

April 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-12

Locations

SE(1)