Internet-delivered Cognitive Behavior Therapy for Functional Abdominal Pain in Adolescents - an Open Pilot.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Faces pain scale - R
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 13-17 at inclusion date
- •fulfilling Rome III-criteria for FAP or FD with:
- •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)
- •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
Outcomes
Primary Outcomes
Faces pain scale - R
Time Frame: Baseline to 12 weeks.
Change in pain intensity measured with a self-rating scale daily during 2 weeks at baseline and daily during 10th to 12th week post treatment for analysis of effect.The Faces Pain Scale is a self-report measure used to assess the intensity of children's pain. Faces have four faces representing least pain and most pain on equal intervals on a scale from 0-10. Its validity is supported by a strong positive correlation (r=0.93, N=76) with a visual analogue scale (VAS) measure in children aged 5-12 years. The metric for scoring (0-10) conforms closely to a linear interval scale.
Secondary Outcomes
- Pain interference index (PII)(Baseline to 10 weeks, baseline to 9 months.)
- Faces pain scale - R(Weekly during treatment (treatment week 1-9).)
- Pediatric Quality of Life Inventory (PedsQL) Generic Core scales age 13-18(Baseline to 10 weeks, baseline to 9 months.)
- TIC-P Parent report(Baseline to 10 weeks, baseline to 9 months)
- IBS-behavioral responses questionnaire (IBS-BRQ)(Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months.)
- Percieved Stress scale (PSS 10)(Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months.)
- Pain reactivity Scale (PRS)(Baseline to 10 weeks, baseline to 9 months,)
- Visceral sensitivity Index (IBS-VSI)(Baseline to 10 weeks, baseline to 9 months.)
- Patient Health Questionnaire (PHQ 9)(Baseline to 10 weeks, baseline to 9 months)
- Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS)(Baseline to 10 weeks, baseline to 9 months)
- Generalized Anxiety Disorder Screener (GAD-7)(Baseline to 10 weeks, baseline to 9 months)
- Functional disability index (FDI)(Baseline to 10 weeks, baseline to 9 months.)
- Children´s Somatization Inventory (CSI-24)(Baseline to 10 weeks, baseline to 9 months.)
- ARCS(Baseline to 10 weeks, baseline to 9 months)
- Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptom Scale(Baseline to 10 weeks, baseline to 9 months.)
- Spence Children's Anxiety Scale (SCAS-C)(Baseline to 10 weeks, baseline to 9 months.)
- TiC-P Adolescents revised version(Baseline to 10 weeks, baseline to 9 months.)
Investigators
Brjann Ljotsson
PhD
Karolinska Institutet