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

NCT02306941 | Completed

• 1 other identifier: FAP pilot ICBT 2015
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Gastrointestinal Disorders; Abdominal Pain; Dyspepsia

Outcome Measures

Primary Outcomes (1)

• Faces pain scale - R

  Change in pain intensity measured with a self-rating scale daily during 2 weeks at baseline and daily during 10th to 12th week post treatment 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 12 weeks.

Secondary Outcomes (18)

• Faces pain scale - R

  Baseline to 9 months

• Faces pain scale - R

  Weekly during treatment (treatment week 1-9).

• Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS)

  Baseline to 10 weeks, baseline to 9 months

• IBS-behavioral responses questionnaire (IBS-BRQ)

  Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months.

• Percieved Stress scale (PSS 10)

  Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months.

Study Arms (1)

Internet-delivered CBT

EXPERIMENTAL

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.

Behavioral: Internet-delivered CBT

Interventions

Internet-delivered CBT 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.

Internet-delivered CBT

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• fulfilling Rome III-criteria for FAP or FD with:
• 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)
• The Rome III questionnaire + clinical interview confirming the diagnosis

You may not qualify if:

• Concurrent serious medical conditions
• Concurrent serous psychiatric diagnosis
• On-going psychological treatment
• On-going abuse or severe parental psychiatric illness in the family
• Lack of regular internet-access

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

BUP-CPF, CAP Research Center

Stockholm, Stockholms County, 11330, Sweden

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Abdominal Pain; Dyspepsia

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Brjánn Ljótsson, 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

Study Record Dates

• First Submitted: November 30, 2014
• First Posted: December 3, 2014
• Study Start: March 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)