Clinical trial NCT02306941: Internet-delivered CBT for Functional Abdominal Pain in Adolescents - a Pilot
Official title: Internet-delivered Cognitive Behavior Therapy for Functional Abdominal Pain in Adolescents - an Open Pilot.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Abdominal Pain
Dyspepsia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 31
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 adjusted for adolescents with functional abdominal pain and functional dyspepsia.

Detailed description: Functional abdominal pain (FAP) and functional dyspepsia, 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 FAP and FD.

Method: Pilot study with a pre-post-design and no control group. The internet-delivered CBT-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls.

Eligibility criteria: Inclusion Criteria:

* Age 13-17 at inclusion date
* fulfilling Rome III-criteria for FAP or FD with:

  1. a written diagnosis from patient's physician and negative required tests (Blood samples: C-reactive protein or erythrocyte sedimentation rate, Blood count and IgA-Transglutaminase. Stool: f-Calprotectin)
  2. The Rome III questionnaire + clinical interview confirming the diagnosis

Exclusion Criteria:

* Concurrent serious medical conditions
* Concurrent serous psychiatric diagnosis
* 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
* Pronounced language skill deficits and learning difficulties lead to exclusion from the study
* Lack of regular internet-access

Primary outcomes:
measure: Faces pain scale - R
timeFrame: Baseline to 12 weeks.
Secondary outcomes:
measure: Faces pain scale - R
timeFrame: Baseline to 9 months
measure: Faces pain scale - R
timeFrame: Weekly during treatment (treatment week 1-9).
measure: Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS)
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: IBS-behavioral responses questionnaire (IBS-BRQ)
timeFrame: Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months.
measure: Percieved Stress scale (PSS 10)
timeFrame: Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months.
measure: Pain reactivity Scale (PRS)
timeFrame: Baseline to 10 weeks, baseline to 9 months,
measure: Pain interference index (PII)
timeFrame: Baseline to 10 weeks, baseline to 9 months.
measure: Functional disability index (FDI)
timeFrame: Baseline to 10 weeks, baseline to 9 months.
measure: Visceral sensitivity Index (IBS-VSI)
timeFrame: Baseline to 10 weeks, baseline to 9 months.
measure: Pediatric Quality of Life Inventory (PedsQL) Generic Core scales age 13-18
timeFrame: Baseline to 10 weeks, baseline to 9 months.
measure: Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptom Scale
timeFrame: Baseline to 10 weeks, baseline to 9 months.
measure: Children´s Somatization Inventory (CSI-24)
timeFrame: Baseline to 10 weeks, baseline to 9 months.
measure: Spence Children's Anxiety Scale (SCAS-C)
timeFrame: Baseline to 10 weeks, baseline to 9 months.
measure: TiC-P Adolescents revised version
timeFrame: Baseline to 10 weeks, baseline to 9 months.
measure: TIC-P Parent report
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: Generalized Anxiety Disorder Screener (GAD-7)
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: Patient Health Questionnaire (PHQ 9)
timeFrame: Baseline to 10 weeks, baseline to 9 months
measure: ARCS
timeFrame: Baseline to 10 weeks, baseline to 9 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: BUP-CPF, CAP Research Center
state: Stockholms County
Study officials:
affiliation: Karolinska Institutet
name: Brjánn Ljótsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: