Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-21 @ 11:32 PM
Study NCT ID:
NCT02113605
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2014-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Behavior Therapy (CBT) for Children With Functional Gastrointestinal Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D015746', 'term': 'Abdominal Pain'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2014-04-01', 'studyFirstSubmitQcDate': '2014-04-10', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'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.'}], 'primaryOutcomes': [{'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.'}], 'secondaryOutcomes': [{'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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Functional gastrointestinal disorders', 'FGID', 'Recurrent abdominal pain', 'Abdominal pain', 'pain-predominant functional gastrointestinal disorders', 'Pediatric pain'], 'conditions': ['Functional Gastrointestinal Disorders (FGID)', 'FGID According to the Rome III Criteria', 'Irritable Bowel Syndrome (IBS)', 'Functional Abdominal Pain', 'Functional Dyspepsia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 8-12 years\n* A diagnosis of a functional gastrointestinal disorder by a treating physician\n\nExclusion Criteria:\n\n* Concurrent serious medical condition or gastrointestinal symptoms likely caused by an organic disorder.\n* Psychiatric disorder more urgent to treat than the abdominal pain.\n* On-going psychological treatment.\n* Absence from school more than 40 %.\n* Ongoing maltreatment, violence or severe parental psychiatric illness.\n* Pronounced language or learning difficulties that hinder the child to benefit from the treatment.'}, 'identificationModule': {'nctId': 'NCT02113605', 'acronym': 'CBT', 'briefTitle': 'Cognitive Behavior Therapy (CBT) for Children With Functional Gastrointestinal Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Exposure-Based CBT for Children With Functional Gastrointestinal Disorders - Development of a Protocol', 'orgStudyIdInfo': {'id': 'FGID Child Pilot-0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive behavior therapy', 'description': 'All included children are treated with a face-to-face exposure-based cognitive behaviour therapy for 10 weeks. There will be no comparison arm.', 'interventionNames': ['Other: Cognitive behavior therapy']}], 'interventions': [{'name': 'Cognitive behavior therapy', 'type': 'OTHER', 'description': 'Exposure-based cognitive behavior therapy in a 10 week face-to-face treatment', 'armGroupLabels': ['Cognitive behavior therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11330', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Child and Adolescent Psychiatry in Stockholm', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Ola Olén, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Ola Olen', 'investigatorAffiliation': 'Karolinska Institutet'}}}}