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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive behavior therapy | Experimental | All included children are treated with a face-to-face exposure-based cognitive behaviour therapy for 10 weeks. There will be no comparison arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavior therapy | Other | Exposure-based cognitive behavior therapy in a 10 week face-to-face treatment |
|
| Measure | Description | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Parental Behavior FGID (PB-FGID) 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. | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ola Olén, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Child and Adolescent Psychiatry in Stockholm | Stockholm | 11330 | Sweden |
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| 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 Pediatric Quality of Life Inventory (Peds QL) 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. |
| 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 Adult responses to children´s symptoms (ARCS) from baseline to 10 weeks. |
| Baseline and 10 weeks. |
| Change in Adult responses to children´s symptoms (ARCS) from baseline to 8 months. | Baseline and 8 months. |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D043183 | Irritable Bowel Syndrome |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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