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

NCT02033161 | Completed

• 1 other identifier: icbt fgid pilot 2012
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Functional Gastrointestinal Disorders

Keywords

Functional gastrointestinal disorders; FGID; Recurrent abdominal pain; Abdominal pain; pain-related functional gastrointestinal disorders

Outcome Measures

Primary Outcomes (1)

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

  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).

  Baseline to 8 weeks, baseline to 8 months.

Secondary Outcomes (6)

• 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.

Study Arms (1)

Internet-delivered CBT

EXPERIMENTAL

Behavioral: Internet-delivered CBT

Interventions

Internet-delivered CBT 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.

Also known as: Internet-delivered Exposure-based Cognitive Behavior Therapy

Internet-delivered CBT

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Child and Adolescent Psychiatry

Stockholm, Sweden

Location

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: January 10, 2014
• Study Start: March 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 10, 2014

Record last verified: 2014-01

Locations

SE (1)