Internet-delivered CBT for Irritable Bowel Syndrome in Adolescents

NCT02306369 | Completed

• 1 other identifier: ibs 13-17 år 2013
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the treatment effects of an internet-delivered CBT-program for adolescents with irritable bowel syndrome.

Conditions

Irritable Bowel Syndrome; Functional Gastrointestinal Disorders

Keywords

ICBT; IBS; FGID; functional abdominal pain; Adolescents; Children; Treatment; CBT; Exposure; Cognitive Behavior Therapy; Internet; Computerized; Abdominal Pain; Functional Pain; Functional Disorders

Outcome Measures

Primary Outcomes (4)

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

  Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 10 weeks for analysis of effect. The GSRS-IBS have 13 items about weekly gastrointestinal symptoms like bloating, hard stool, abdominal pain etc. It is a seven-point Likert scale from 1 (no discomfort at all) to 7 (very severe discomfort). The GSRS-IBS has excellent psychometric properties with internal consistency between α = .74 (for abdominal pain) to α = .85 (for satiety).

  Baseline to 10 weeks.

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

  Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 9 months for analysis of effect. The GSRS-IBS have 13 items about weekly gastrointestinal symptoms like bloating, hard stool, abdominal pain etc. It is a seven-point Likert scale from 1 (no discomfort at all) to 7 (very severe discomfort). The GSRS-IBS has excellent psychometric properties with internal consistency between α = .74 (for abdominal pain) to α = .85 (for satiety).

  Baseline to 9 months.

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

  Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 15 months baseline for analysis of effect. The GSRS-IBS have 13 items about weekly gastrointestinal symptoms like bloating, hard stool, abdominal pain etc. It is a seven-point Likert scale from 1 (no discomfort at all) to 7 (very severe discomfort). The GSRS-IBS has excellent psychometric properties with internal consistency between α = .74 (for abdominal pain) to α = .85 (for satiety).

  Baseline to 15 months.

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

  Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 27 months for analysis of effect. The GSRS-IBS have 13 items about weekly gastrointestinal symptoms like bloating, hard stool, abdominal pain etc. It is a seven-point Likert scale from 1 (no discomfort at all) to 7 (very severe discomfort). The GSRS-IBS has excellent psychometric properties with internal consistency between α = .74 (for abdominal pain) to α = .85 (for satiety).

  Baseline to 27 months.

Secondary Outcomes (17)

• Faces pain scale - R

  Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.

• IBS-behavioral responses questionnaire (IBS-BRQ).

  Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.

• Percieved Stress scale (PSS 10)

  Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.

• Pain reactivity Scale (PRS)

  Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.

• Pain interference index (PII)

  Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.

Study Arms (2)

Treatment as usual

NO INTERVENTION

A wait-list control.

Internetdelivered exposure-based 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: Internetdelivered exposure-based CBT

Interventions

Internetdelivered exposure-based CBT BEHAVIORAL

The Internet-delivered exposure treatment is based on the well-established internet-delivered CBT-treatment for IBS in adults, and adapted for adolescents and their parents. The feasibility of the treatment were tested in a pilot study during 2012. Components in the treatment are exposure for symptoms and parent training. 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. 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.

Internetdelivered exposure-based 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 IBS with a written statement from patient's physician confirming a diagnosis of IBS and negative required tests (Blood samples: C-reactive protein or erythrocyte sedimentation rate, Blood count and IgA-Transglutaminase. Stool: f-Calprotectin).

You may not qualify if:

• concurrent serious medical conditions.
• a psychiatric diagnosis, judged to be a more important treatment target than the abdominal pain.
• 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)

Child and Adolescent Psychiatry (CAP) Research Center

Stockholm, County of Stockholm, 113 30, Sweden

Location

Related Publications (1)

• Sampaio F, Bonnert M, Olen O, Hedman E, Lalouni M, Lenhard F, Ljotsson B, Ssegonja R, Serlachius E, Feldman I. Cost-effectiveness of internet-delivered cognitive-behavioural therapy for adolescents with irritable bowel syndrome. BMJ Open. 2019 Jan 24;9(1):e023881. doi: 10.1136/bmjopen-2018-023881.

  PMID: 30679293 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Gastrointestinal Diseases; Abdominal Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Brjánn Ljótsson, PhD

  Departement of Clinical neuropsychology, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: December 3, 2014
• Study Start: November 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: November 18, 2017
• Last Updated: August 10, 2018

Record last verified: 2018-08

Locations

SE (1)