Cognitive Behavior Therapy (CBT) for Children With Functional Gastrointestinal Disorders

Functional Dyspepsia Clinical Trial

— CBT  

Official title:

Exposure-Based CBT for Children With Functional Gastrointestinal Disorders - Development of a Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113605
• Other study ID #: FGID Child Pilot-0
• Status: Completed
• Phase: N/A
• First received: April 1, 2014
• Last updated: December 1, 2015
• Start date: April 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the trial is to develop a treatment protocol to be used in trials studying internet-delivered CBT for children with functional gastrointestinal disorders (FGID). The study size is not based on power calculations but the estimated sample necessary to develop a treatment protocol. This study will include 20-30 children with FGID and their parents who will be treated individually (face-to-face). The treatment consists of 10 weekly sessions of exposure-based CBT. The study uses a pre- post-design with no control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• Age between 8-12 years

• A diagnosis of a functional gastrointestinal disorder by a treating physician

Exclusion Criteria:

• Concurrent serious medical condition or gastrointestinal symptoms likely caused by an organic disorder.

• Psychiatric disorder more urgent to treat than the abdominal pain.

• On-going psychological treatment.

• Absence from school more than 40 %.

• Ongoing maltreatment, violence or severe parental psychiatric illness.

• Pronounced language or learning difficulties that hinder the child to benefit from the treatment.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Pain
• Digestive System Diseases
• Disease
• FGID According to the Rome III Criteria
• Functional Abdominal Pain
• Functional Dyspepsia
• Functional Gastrointestinal Disorders (FGID)
• Gastrointestinal Diseases
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome (IBS)

Intervention

Other:
• Cognitive behavior therapy
Exposure-based cognitive behavior therapy in a 10 week face-to-face treatment

Locations

Country	Name	City	State
Sweden	Child and Adolescent Psychiatry in Stockholm	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Parental Behavior FGID (PB-FGID) from baseline to 10 weeks.		Baseline and 10 weeks.	No
Other	Change in Parental Behavior FGID (PB-FGID) from baseline to 8 months.		Baseline and 8 months.	No
Other	Change in Adult responses to children´s symptoms (ARCS) from baseline to 10 weeks.		Baseline and 10 weeks.	No
Other	Change in Adult responses to children´s symptoms (ARCS) from baseline to 8 months.		Baseline and 8 months.	No
Primary	Change in Faces Pain Rating Scale (FACES) from baseline to 10 weeks		Baseline and 10 weeks	No
Primary	Change in Faces Pain Rating Scale (FACES) from baseline to 8 months.		Baseline and 8 months.	No
Secondary	Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 10 weeks.		Baseline and 10 weeks.	No
Secondary	Change in Children´s Somatization Inventory (CSI 24) from baseline to 10 weeks		Baseline and 10 weeks.	No
Secondary	Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 10 weeks		Baseline and 10 weeks.	No
Secondary	Change in Functional Disability Index (FDI) from baseline to 10 weeks.		Baseline and 10 weeks.	No
Secondary	Change in Pain Reactivity Scale from baseline to 10 weeks.		Baseline and 10 weeks.	No
Secondary	Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 10 weeks.		Baseline and 10 weeks.	No
Secondary	Change in Spence Children Anxiety Scale (SCAS) from baseline to 10 weeks.		Baseline and 10 weeks.	No
Secondary	Change in Child Depression Inventory (CDI) from baseline to 10 weeks.		Baseline and 10 weeks.	No
Secondary	Change in Pain Interference Index (PII) from baseline to 10 weeks.		Baseline and 10 weeks.	No
Secondary	Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 10 weeks.		Baseline and 10 weeks.	No
Secondary	Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 8 months.		Baseline and 8 months	No
Secondary	Change in Children´s Somatization Inventory (CSI 24) from baseline to 8 months		Baseline and 8 months.	No
Secondary	Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 8 months.		Baseline and 8 months.	No
Secondary	Change in Functional Disability Index (FDI) from baseline to 8 months.		Baseline and 8 months.	No
Secondary	Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 8 months.		Baseline and 8 months.	No
Secondary	Change in Spence Children Anxiety Scale (SCAS) from baseline to 8 months.		Baseline and 8 months.	No
Secondary	Change in Child Depression Inventory (CDI) from baseline to 8 months.		Baseline and 8 months.	No
Secondary	Change in Pain Interference Index (PII) from baseline to 8 months.		Baseline and 8 months.	No
Secondary	Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 8 months.		Baseline and 8 months.	No
Secondary	Change in Pain Reactivity Scale from baseline to 8 months.		Baseline and 8 months.	No