FGID According to the Rome III Criteria, Functional Abdominal Pain, Functional Dyspepsia, Functional Gastrointestinal Disorders (FGID), Irritable Bowel Syndrome (IBS)
Conditions
Keywords
Functional gastrointestinal disorders, FGID, Recurrent abdominal pain, Abdominal pain, pain-predominant functional gastrointestinal disorders, Pediatric pain
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.
Interventions
OTHERCognitive behavior therapy
Exposure-based cognitive behavior therapy in a 10 week face-to-face treatment
Sponsors
Karolinska Institutet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Faces Pain Rating Scale (FACES) from baseline to 10 weeks | Baseline and 10 weeks |
| Change in Faces Pain Rating Scale (FACES) from baseline to 8 months. | Baseline and 8 months. |
Secondary
| Measure | Time frame |
|---|---|
| Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 10 weeks. | Baseline and 10 weeks. |
| Change in Child Depression Inventory (CDI) from baseline to 8 months. | Baseline and 8 months. |
| Change in Pain Interference Index (PII) from baseline to 8 months. | Baseline and 8 months. |
| Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 8 months. | Baseline and 8 months. |
| Change in Pain Reactivity Scale from baseline to 8 months. | Baseline and 8 months. |
| Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 10 weeks. | Baseline and 10 weeks. |
| Change in Children´s Somatization Inventory (CSI 24) from baseline to 10 weeks | Baseline and 10 weeks. |
| Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 10 weeks | Baseline and 10 weeks. |
| Change in Functional Disability Index (FDI) from baseline to 10 weeks. | Baseline and 10 weeks. |
| Change in Pain Reactivity Scale from baseline to 10 weeks. | Baseline and 10 weeks. |
| Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 10 weeks. | Baseline and 10 weeks. |
| Change in Spence Children Anxiety Scale (SCAS) from baseline to 10 weeks. | Baseline and 10 weeks. |
| Change in Child Depression Inventory (CDI) from baseline to 10 weeks. | Baseline and 10 weeks. |
| Change in Pain Interference Index (PII) from baseline to 10 weeks. | Baseline and 10 weeks. |
| Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 8 months. | Baseline and 8 months |
| Change in Children´s Somatization Inventory (CSI 24) from baseline to 8 months | Baseline and 8 months. |
| Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 8 months. | Baseline and 8 months. |
| Change in Functional Disability Index (FDI) from baseline to 8 months. | Baseline and 8 months. |
| Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 8 months. | Baseline and 8 months. |
| Change in Spence Children Anxiety Scale (SCAS) from baseline to 8 months. | Baseline and 8 months. |
Other
| Measure | Time frame |
|---|---|
| Change in Adult responses to children´s symptoms (ARCS) from baseline to 8 months. | Baseline and 8 months. |
| Change in Parental Behavior FGID (PB-FGID) from baseline to 10 weeks. | Baseline and 10 weeks. |
| Change in Adult responses to children´s symptoms (ARCS) from baseline to 10 weeks. | Baseline and 10 weeks. |
| Change in Parental Behavior FGID (PB-FGID) from baseline to 8 months. | Baseline and 8 months. |
Countries
Sweden
Outcome results
None listed