Digital Psychological Intervention for Pediatric Functional Abdominal Pain Disorders in Primary Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-12-31

Brief Summary

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The project involves researching two psychological treatments for functional abdominal pain in children. The treatments will be offered to children as an early intervention, at primary care level. The study will aim to find out if the treatments are effective and which children the different treatments are effective for.

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Detailed Description

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The research project involves evaluating the efficacy of a collaborative care pathway with a two-level stepped-care model for pediatric FAPD where specialist level community-based pediatric clinics (CPC, Swedish Barn- och ungdomsmedicinsk mottagning) provide consultation and intervention to primary care health centers (HC). As children with FAPD benefit from early intervention, a stepped-care model of delivery at primary care level via a collaborative pathway could potentially be a way to divert more resources to those who need it most. The model explores a collaboration whereby an initial diagnosis of FAPD will be made by a general practitioner at a participating HC, following which digital interventions with two levels, managed by CPC, will be provided. The aim of the study is to explore the effectiveness of the two levels in the stepped-care model, where level 1 involves digitally provided psychoeducation and enhanced information about FAPD, and level 2 is a digitally delivered cognitive behavior therapy (CBT) based psychological intervention for FAPD. The CBT intervention is a fully digital version of the Aim to Decrease Anxiety and Pain Treatment (ADAPT), which has been developed into a Swedish language version through a project funded by the innovation fund in Region Vastragotaland (VGR).

Conditions

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Functional Abdominal Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention level 1 - patient education treatment.

Participants who are randomized to experimental condition arm 1 will be offered patient education for functional abdominal pain disorder (FAPD).

Group Type EXPERIMENTAL

Digital patient education

Intervention Type OTHER

This educative intervention includes both medical and psychological explanations, as well as basic strategies to manage pediatric FAPD. The medical information spans the topics of pain, functional abdominal pain and general advice in terms of child health, and the psychological information is based on cognitive-behavioural and pain management theoretical approaches. The intervention consists of six short, animated films with a total run-time of approximately 30 minutes. The films each cover one of the following topics; Why and how do we feel pain? What is functional abdominal pain? How to help: general advice, Thoughts, feelings and behaviour, Goals and strategies. The films are accessed by the patient via 1177.se and maintained on the SoB (Stöd- och behandling) platform that is recognised by the care provider as meeting current safety criteria and standards.

Intervention level 2 - patient education and iCBT

Participants who are randomized to experimental condition arm 2 will be offered patient education treatment and internet delivered cognitive behavior therapy (iCBT) treatment.

Group Type EXPERIMENTAL

Digital patient education and iCBT

Intervention Type OTHER

This includes the educative intervention and a fully digital, four session version of the Aim to Decrease Anxiety and Pain Treatment (ADAPT), a CBT treatment program for FAPD. The treatment focuses on pain-management through the following core elements; The Pain-Gate Theory, breathing and relaxation strategies, calming statements, activity pacing, problem solving and behavior activation. This intervention is also accessed by the patient via 1177.se and maintained on the SoB (Stöd- och behandling) platform.

Interventions

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Digital patient education

This educative intervention includes both medical and psychological explanations, as well as basic strategies to manage pediatric FAPD. The medical information spans the topics of pain, functional abdominal pain and general advice in terms of child health, and the psychological information is based on cognitive-behavioural and pain management theoretical approaches. The intervention consists of six short, animated films with a total run-time of approximately 30 minutes. The films each cover one of the following topics; Why and how do we feel pain? What is functional abdominal pain? How to help: general advice, Thoughts, feelings and behaviour, Goals and strategies. The films are accessed by the patient via 1177.se and maintained on the SoB (Stöd- och behandling) platform that is recognised by the care provider as meeting current safety criteria and standards.

Intervention Type OTHER

Digital patient education and iCBT

This includes the educative intervention and a fully digital, four session version of the Aim to Decrease Anxiety and Pain Treatment (ADAPT), a CBT treatment program for FAPD. The treatment focuses on pain-management through the following core elements; The Pain-Gate Theory, breathing and relaxation strategies, calming statements, activity pacing, problem solving and behavior activation. This intervention is also accessed by the patient via 1177.se and maintained on the SoB (Stöd- och behandling) platform.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Eligible participants are children and young people aged 8-14.
* Diagnosed with functional abdominal pain disorders by their physician.
* Diagnosed at one of the participating primary care health centres.

Exclusion Criteria

* Children and young people with scores above the clinical cut-off on the Revised Child Anxiety and Depression Scale (RCADS).
* Children who do not follow the mainstream Swedish National Curriculum due to learning disabilities.

Minimum Eligible Age

8 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes