Internet-delivered CBT for Functional Abdominal Pain in Adolescents - a Pilot

NCT ID: NCT02306941

Last Updated: 2017-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-12-31

Brief Summary

This pilot-study aims to evaluate the treatment effects and feasibility of an internet-delivered CBT-program adjusted for adolescents with functional abdominal pain and functional dyspepsia.

Detailed Description

Functional abdominal pain (FAP) and functional dyspepsia, are common in adolescents and associated with impaired quality of life. In adults with IBS, internet-delivered CBT leads to reduced symptoms and increased quality of life, but studies in children are lacking. This pilot-study aim to evaluate the treatment effects and feasibility of an internet-delivered CBT-program for adolescents with FAP and FD.

Method: Pilot study with a pre-post-design and no control group. The internet-delivered CBT-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls.

Conditions

Functional Gastrointestinal Disorders; Abdominal Pain; Dyspepsia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet-delivered CBT

10 sessions of ICBT during 10 weeks for the adolescents. 5 session of parent training during 10 weeks for parents. Therapist support is provided at least once weekly through the platform developed for the purpose. Therapists are trained CBT-psychologists.

Group Type: EXPERIMENTAL

Internet-delivered CBT

Intervention Type: BEHAVIORAL

The Internet-delivered exposure treatment is based on the well-established internet-delivered CBT-treatment for IBS in adults, adapted for adolescents with FAP/FD and their parents. 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 adolescents, 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.

Interventions

Internet-delivered CBT

The Internet-delivered exposure treatment is based on the well-established internet-delivered CBT-treatment for IBS in adults, adapted for adolescents with FAP/FD and their parents. 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 adolescents, 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 13-17 at inclusion date
• fulfilling Rome III-criteria for FAP or FD with:

1. a written diagnosis from patient's physician and negative required tests (Blood samples: C-reactive protein or erythrocyte sedimentation rate, Blood count and IgA-Transglutaminase. Stool: f-Calprotectin)

2. The Rome III questionnaire + clinical interview confirming the diagnosis

Exclusion Criteria

• Concurrent serious medical conditions
• Concurrent serous psychiatric diagnosis
• On-going psychological treatment
• Absence from school exceeding an average of 2 days a week is a cause for exclusion since high absence demands more intensive interventions than can be offered in ICBT
• On-going abuse or severe parental psychiatric illness in the family
• Pronounced language skill deficits and learning difficulties lead to exclusion from the study
• Lack of regular internet-access

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Brjann Ljotsson

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brjánn Ljótsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

BUP-CPF, CAP Research Center

Stockholm, Stockholms County, Sweden

Countries

Sweden

Other Identifiers

FAP pilot ICBT 2015

Identifier Type: -

Identifier Source: org_study_id