Clinical trial NCT02306369: Internet-delivered CBT for Irritable Bowel Syndrome in Adolescents
Official title: Internet-delivered CBT for Irritable Bowel Syndrome in Adolescents - a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 101
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Irritable bowel syndrome (IBS) is prevalent and associated with low quality of life in adolescents. Medical or dietary treatments lack evident efficiency, while psychosocial interventions, i.e. cognitive behavior therapy (CBT)has shown promising effects in face-to-face treatments. Therapists trained to deliver CBT for IBS are scarce, leading to a situation where very few adolescents with IBS receive the only evidence-based intervention. Exposure-based internet-delivered CBT (ICBT) for adults with IBS has shown strong stable effects and cost-efficency. Our aim is to develop a treatment that enhances the availability to evidence-based treatment for children and adolescents with IBS. Such a treatment could swiftly be implemented in regular health care for this large population. The main purpose of this study is to compare the effectiveness of exposure-based ICBT to treatment as usual (wait-list) for adolescents with IBS.

Eligibility criteria: Inclusion Criteria:

* Age 13-17 at inclusion date.
* 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).

Exclusion Criteria:

* concurrent serious medical conditions.
* a psychiatric diagnosis, judged to be a more important treatment target than the abdominal pain.
* on-going psychological treatment.
* absence from school exceeding an average of 2 days a week is a cause for exclusion since high absence demands more intensive interventions than can be offered in ICBT.
* on-going abuse or severe parental psychiatric illness in the family.
* since treatment format assumes normal reading and writing skills, pronounced language skill deficits and learning difficulties lead to exclusion from the study.
* lack of regular internet-access.

Primary outcomes:
measure: Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS).
timeFrame: Baseline to 10 weeks.
measure: Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS).
timeFrame: Baseline to 9 months.
measure: Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS).
timeFrame: Baseline to 15 months.
measure: Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS).
timeFrame: Baseline to 27 months.
Secondary outcomes:
measure: Faces pain scale - R
timeFrame: Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.
measure: IBS-behavioral responses questionnaire (IBS-BRQ).
timeFrame: Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.
measure: Percieved Stress scale (PSS 10)
timeFrame: Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.
measure: Pain reactivity Scale (PRS)
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.
measure: Pain interference index (PII)
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.
measure: Functional disability index (FDI)
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.
measure: Visceral sensitivity Index (IBS-VSI)
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.
measure: Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS).
timeFrame: Weekly during treatment (treatment week 1-9).
measure: Pediatric Quality of Life Inventory (PedsQL) Generic Core scales age 13-18
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.
measure: Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptom Scale
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.
measure: Children´s Somatization Inventory (CSI-24)
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.
measure: Spence Children's Anxiety Scale (SCAS-C)
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.
measure: TiC-P Adolescents revised version
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.
measure: TIC-P Parent report
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.
measure: Generalized Anxiety Disorder Screener (GAD-7)
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.
measure: Patient Health Questionnaire (PHQ 9)
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.
measure: ARCS
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Child and Adolescent Psychiatry (CAP) Research Center
state: County Of Stockholm
Study officials:
affiliation: Departement of Clinical neuropsychology, Karolinska Institutet
name: Brjánn Ljótsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.