Internet-Delivered CBT for Children With Functional Abdominal Pain Disorders

NCT ID: NCT02873078

Last Updated: 2020-09-16

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

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-01-31

Brief Summary

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This randomized controlled study aims to evaluate the efficacy of exposure-based Internet-delivered cognitive behavior therapy for children 8-12 years with Functional Abdominal Pain Disorders. The children participate along with their parents, who will also receive specific modules with information on how to support their children in the treatment. Predictors and mediators for treatment effects will be studied as well as the cost effectiveness of the intervention.

Detailed Description

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Conditions

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Functional Abdominal Pain Disorders

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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Internet-delivered CBT

Children and parents will receive 10 weekly modules of cognitive behavior therapy (CBT). Parents will also receive 10 weekly modules. Main components in the children's modules are exposure for abdominal symptoms, feared stimuli and situations in which the children are afraid of having symptoms. The parental receive information on how they can support their children in the treatment and how to reinforce health y behaviors and decrease attention to pain behaviors. Therapist support is provided through written messages within the secure platform.

Group Type EXPERIMENTAL

Internet-delivered Cognitive behavior therapy

Intervention Type BEHAVIORAL

The treatment is delivered via an online platform and is based on interventions for adults, adolescents and children tested in previous trials. Therapists are CBT-psychologists och students in clinical psychology under supervision.

Waiting list

This is a wait-list control where the children and parents are allowed to carry on with any contacts within the health-care system, exempt for psychological treatments.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Internet-delivered Cognitive behavior therapy

The treatment is delivered via an online platform and is based on interventions for adults, adolescents and children tested in previous trials. Therapists are CBT-psychologists och students in clinical psychology under supervision.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Children 8-12 years with either irritable bowel syndrome, functional dyspepsia or functional abdominal pain - not otherwise specified diagnosed according to Rome-III or Rome-IV criteria.
* Psychopharmacological medication stable for at least a month if medicating.
* Child and at least one parent speaking and writing swedish.
* Access to computer with Internet connection.

Exclusion Criteria

* Severe somatic disorder and/or if the child fulfills criteria of other disorder that better explains the abdominal symptoms.
* Severe psychiatric or social problems that needs other care.
* Ongoing psychological treatment.
* School absenteeism more than 40 %.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Ola Olen

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ola Olén, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Child and Adolescent Psychiatry in Stockholm

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Lalouni M, Ljotsson B, Bonnert M, Ssegonja R, Benninga M, Bjureberg J, Hogstrom J, Sahlin H, Simren M, Feldman I, Hedman-Lagerlof E, Serlachius E, Olen O. Clinical and Cost Effectiveness of Online Cognitive Behavioral Therapy in Children With Functional Abdominal Pain Disorders. Clin Gastroenterol Hepatol. 2019 Oct;17(11):2236-2244.e11. doi: 10.1016/j.cgh.2018.11.043. Epub 2018 Nov 28.

Reference Type DERIVED
PMID: 30502501 (View on PubMed)

Other Identifiers

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RCT ICBT FAPD

Identifier Type: -

Identifier Source: org_study_id

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