Skip to main content
Clinical Trials/NCT02033161
NCT02033161
Completed
Not Applicable

Internet-delivered Cognitive Behavior Therapy for Adolescents With Functional Gastrointestinal Disorders: a Pilot Study

Karolinska Institutet1 site in 1 country29 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Irritable Bowel Syndrome
Sponsor
Karolinska Institutet
Enrollment
29
Locations
1
Primary Endpoint
Change in gastrointestinal symptoms from baseline to 8 weeks, and from baseline to 6 months after treatment.
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

This pilot-study aims to evaluate the treatment effects and feasibility of an internet-delivered CBT-program for adolescents with functional gastrointestinal disorders.

Detailed Description

Functional gastrointestinal disorders (FGID), including irritable bowel syndrome (IBS), functional dyspepsia (FD) and functional abdominal pain (FAP), 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 FGID. Method: Pilot study with a pre-post-design and no control group. The internet-delivered CBT-program lasted for 8 weeks and included weekly therapist support, consisting of online messages and telephone calls. Assessment points were baseline, post-treatment and 6 months follow-up. Analysis: Effect sizes and within-group differences were calculated in an intent-to-treat analysis using Cohens' d and Student's t-test.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
June 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brjann Ljotsson

PhD

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

  • age between 13 and 17 years old.
  • a diagnosis of a functional gastrointestinal disorder by treating physician, e.g. IBS, FD or FAP.
  • adolescent and one parent should have easy access to the Internet, some computer experience and good Swedish language skills.

Exclusion Criteria

  • concurrent serious medical conditions or gastrointestinal symptoms likely caused by an organic disorder.
  • psychiatric diagnosis more urgent to treat than the abdominal pain.
  • on-going psychological treatment.
  • absence from school more than 20%.
  • on-going maltreatment, violence or severe parental psychiatric illness in the family.
  • pronounced language and learning difficulties depending on whether the youth was expected to benefit from the treatment or not.

Outcomes

Primary Outcomes

Change in gastrointestinal symptoms from baseline to 8 weeks, and from baseline to 6 months after treatment.

Time Frame: Baseline to 8 weeks, baseline to 8 months.

Measured with a self-report scale, GSRS-IBS, that have 13 items about weekly gastro-intestinal symptoms like bloating, hard stool, abdominal pain etc. It is a seven-point Likert scale, from 1 ("no trouble 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).

Secondary Outcomes

  • Change in pain reactivity from baseline to 8 weeks, and from baseline to 6 months after treatment.(Baseline to 8 weeks, baseline to 8 months.)
  • Change in pain interference on activities from baseline to 8 weeks, and baseline to 6 months after treatment.(Baseline to 8 weeks, baseline to 8 months.)
  • Change in function from baseline to 8 weeks and from baseline to 6 months after treatment.(Baseline to 8 weeks, baseline to 8 months.)
  • Change in sensitivity to symptoms of anxiety from baseline to 8 weeks, and from baseline to 6 months after treatment.(Baseline to 8 weeks, baseline to 8 months.)
  • Change in level of depression from baseline to 8 weeks and from baseline to 6 months after treatment.(Baseline, 8 weeks and 8 months.)
  • Change in level of perceived stress from baseline to 8 weeks and from baseline to 6 months after treatment.(Baseline, 8 weeks and 8 months.)

Study Sites (1)

Loading locations...

Similar Trials