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

NCT ID: NCT02033161

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-06-30

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.

Conditions

Irritable Bowel Syndrome; Functional Gastrointestinal Disorders

Study Design

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

Study Groups

Internet-delivered CBT

Group Type: EXPERIMENTAL

Internet-delivered CBT

Intervention Type: BEHAVIORAL

The internet-treatment consisted of six modules during 8 weeks. Part 1: education about FGID and the treatment model. Part 2: individual symptom behavior. Part 3: toilet habits, or other common symptom behavior. Part 4 and Part 5: Exposure during 4 weeks. Part 6: relapse prevention.

Parents received four modules over 8 weeks consisting of psycho-education about FGID and the treatment model, increased positive time with the child in order to reduce attention to pain, parental symptom behavior, support child exposure and relapse prevention.

The therapists gave feedback weekly . All participants had at least 1 telephone call from their therapist during the fifth and sixth week of treatment.

Interventions

Internet-delivered CBT

The internet-treatment consisted of six modules during 8 weeks. Part 1: education about FGID and the treatment model. Part 2: individual symptom behavior. Part 3: toilet habits, or other common symptom behavior. Part 4 and Part 5: Exposure during 4 weeks. Part 6: relapse prevention.

Parents received four modules over 8 weeks consisting of psycho-education about FGID and the treatment model, increased positive time with the child in order to reduce attention to pain, parental symptom behavior, support child exposure and relapse prevention.

The therapists gave feedback weekly . All participants had at least 1 telephone call from their therapist during the fifth and sixth week of treatment.

Intervention Type: BEHAVIORAL

Other Intervention Names

Internet-delivered Exposure-based Cognitive Behavior Therapy

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.

• 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

Departement of clinical neuropsychology, Karolinska Institutet

Locations

Child and Adolescent Psychiatry

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

icbt fgid pilot 2012

Identifier Type: -

Identifier Source: org_study_id