Clinical trial NCT02033161: Internet-delivered Cognitive Behavior Therapy for Adolescents With Functional Gastrointestinal Disorders: a Pilot Study
Official title: Internet-delivered Cognitive Behavior Therapy for Adolescents With Functional Gastrointestinal Disorders: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Functional Gastrointestinal Disorders
Keywords: Functional gastrointestinal disorders
FGID
Recurrent abdominal pain
Abdominal pain
pain-related functional gastrointestinal disorders
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 29
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in gastrointestinal symptoms from baseline to 8 weeks, and from baseline to 6 months after treatment.
timeFrame: Baseline to 8 weeks, baseline to 8 months.
Secondary outcomes:
measure: Change in pain reactivity from baseline to 8 weeks, and from baseline to 6 months after treatment.
timeFrame: Baseline to 8 weeks, baseline to 8 months.
measure: Change in pain interference on activities from baseline to 8 weeks, and baseline to 6 months after treatment.
timeFrame: Baseline to 8 weeks, baseline to 8 months.
measure: Change in function from baseline to 8 weeks and from baseline to 6 months after treatment.
timeFrame: Baseline to 8 weeks, baseline to 8 months.
measure: Change in sensitivity to symptoms of anxiety from baseline to 8 weeks, and from baseline to 6 months after treatment.
timeFrame: Baseline to 8 weeks, baseline to 8 months.
measure: Change in level of depression from baseline to 8 weeks and from baseline to 6 months after treatment.
timeFrame: Baseline, 8 weeks and 8 months.
measure: Change in level of perceived stress from baseline to 8 weeks and from baseline to 6 months after treatment.
timeFrame: Baseline, 8 weeks and 8 months.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Child and Adolescent Psychiatry
Study officials:
affiliation: Departement of clinical neuropsychology, Karolinska Institutet
name: Brjánn Ljótsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: