Clinical trial NCT02113605: Cognitive Behavior Therapy (CBT) for Children With Functional Gastrointestinal Disorders
Official title: Exposure-Based CBT for Children With Functional Gastrointestinal Disorders - Development of a Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Gastrointestinal Disorders (FGID)
FGID According to the Rome III Criteria
Irritable Bowel Syndrome (IBS)
Functional Abdominal Pain
Functional Dyspepsia
Keywords: Functional gastrointestinal disorders
FGID
Recurrent abdominal pain
Abdominal pain
pain-predominant functional gastrointestinal disorders
Pediatric pain
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-04-14
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Faces Pain Rating Scale (FACES) from baseline to 10 weeks
timeFrame: Baseline and 10 weeks
measure: Change in Faces Pain Rating Scale (FACES) from baseline to 8 months.
timeFrame: Baseline and 8 months.
Secondary outcomes:
measure: Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 10 weeks.
timeFrame: Baseline and 10 weeks.
measure: Change in Children´s Somatization Inventory (CSI 24) from baseline to 10 weeks
timeFrame: Baseline and 10 weeks.
measure: Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 10 weeks
timeFrame: Baseline and 10 weeks.
measure: Change in Functional Disability Index (FDI) from baseline to 10 weeks.
timeFrame: Baseline and 10 weeks.
measure: Change in Pain Reactivity Scale from baseline to 10 weeks.
timeFrame: Baseline and 10 weeks.
measure: Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 10 weeks.
timeFrame: Baseline and 10 weeks.
measure: Change in Spence Children Anxiety Scale (SCAS) from baseline to 10 weeks.
timeFrame: Baseline and 10 weeks.
measure: Change in Child Depression Inventory (CDI) from baseline to 10 weeks.
timeFrame: Baseline and 10 weeks.
measure: Change in Pain Interference Index (PII) from baseline to 10 weeks.
timeFrame: Baseline and 10 weeks.
measure: Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 10 weeks.
timeFrame: Baseline and 10 weeks.
measure: Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 8 months.
timeFrame: Baseline and 8 months
measure: Change in Children´s Somatization Inventory (CSI 24) from baseline to 8 months
timeFrame: Baseline and 8 months.
measure: Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 8 months.
timeFrame: Baseline and 8 months.
measure: Change in Functional Disability Index (FDI) from baseline to 8 months.
timeFrame: Baseline and 8 months.
measure: Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 8 months.
timeFrame: Baseline and 8 months.
measure: Change in Spence Children Anxiety Scale (SCAS) from baseline to 8 months.
timeFrame: Baseline and 8 months.
measure: Change in Child Depression Inventory (CDI) from baseline to 8 months.
timeFrame: Baseline and 8 months.
measure: Change in Pain Interference Index (PII) from baseline to 8 months.
timeFrame: Baseline and 8 months.
measure: Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 8 months.
timeFrame: Baseline and 8 months.
measure: Change in Pain Reactivity Scale from baseline to 8 months.
timeFrame: Baseline and 8 months.
Other outcomes:
measure: Change in Parental Behavior FGID (PB-FGID) from baseline to 10 weeks.
timeFrame: Baseline and 10 weeks.
measure: Change in Parental Behavior FGID (PB-FGID) from baseline to 8 months.
timeFrame: Baseline and 8 months.
measure: Change in Adult responses to children´s symptoms (ARCS) from baseline to 10 weeks.
timeFrame: Baseline and 10 weeks.
measure: Change in Adult responses to children´s symptoms (ARCS) from baseline to 8 months.
timeFrame: Baseline and 8 months.
Locations:
city: Stockholm
country: Sweden
facility: Child and Adolescent Psychiatry in Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Ola Olén, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: