Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-31 @ 9:39 AM
Study NCT ID:
NCT06309004
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2024-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of an Online ACT Intervention for Disorders of Gut-Brain Interaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2024-03-07', 'studyFirstSubmitQcDate': '2024-03-07', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Focus group interviews', 'timeFrame': '60-90 minutes per interview', 'description': 'Focus group interviews'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DGBI', 'ACT', 'Anxiety', 'Depression'], 'conditions': ['Anxiety and Depression', 'Disorders of Gut-brain Interaction']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to develop and test the iACTforDGBI intervention in a sample of Swedish individuals with DGBI (Disorders of Gut-Brain Interaction).\n\nThe first substudy of this project (Substudy 1) aims to answer the following question: How can the design of iACTforDGBI be tailored to meet the specific needs of individuals with DGBI and clinically meaningful symptoms of anxiety and depression?\n\nParticipants (individuals with symptoms compatible with a DGBI and anxiety and/or depression, and healthcare professionals working with DGBI patients) will be asked to participate in online focus-group interviews and provide information on their views of a preliminary version of the iACTforDGBi intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with DGBI:\n\nPeople with clinically meaningful symptom severity of DGBI, and depression and/or anxiety.\n\nHealthcare professionals:\n\nPhysicians, psychologists, nurses, and dietitians working from different regions in Sweden.', 'healthyVolunteers': True, 'eligibilityCriteria': 'DGBI participants:\n\nInclusion Criteria:\n\n1. Age between 18 and 75 years;\n2. Exhibiting clinical symptom severity for at least one DGBI diagnosis (assessed with the Rome IV Diagnostic Questionnaire for Functional Gastrointestinal Disorders in Adults (Palsson et al., 2016));\n3. Clinically meaningful levels of depressive symptoms or anxiety: score ≥ 13 on the Montgomery Åsberg Depression Rating Scale (MADRS; depressive symptoms), or score ≥ 10 on the Generalized Anxiety Disorder scale-7 (GAD-7; anxiety symptoms; Spitzer et al., 2006);\n4. Stable medication for psychiatric symptoms including anxiety, depression, and sleep problems for at least two months prior to intervention;\n5. Ability to read and write Swedish;\n6. Access to a device (like a computer, tablet, or smartphone) with access to the internet and that can be used to attend video conferences and preview the intervention platform (i.e., have a microphone and speakers or headphones).\n\nExclusion Criteria:\n\n1. Currently undergoing any form of psychological intervention;\n2. Increased risk of suicide (≥4 points on MADRS item 9);\n3. Severe depression (≥34 points on MADRS).\n\nHealthcare professionals:\n\nInclusion Criteria:\n\na) Being a healthcare professional currently working with DGBI patients and/or with ACT-based/digital interventions.'}, 'identificationModule': {'nctId': 'NCT06309004', 'acronym': 'iACTforDGBI', 'briefTitle': 'Development of an Online ACT Intervention for Disorders of Gut-Brain Interaction', 'organization': {'class': 'OTHER', 'fullName': 'Örebro University, Sweden'}, 'officialTitle': 'Development, Feasibility, Efficacy, and Cost-effectiveness of an Online ACT Intervention for Disorders of Gut-Brain Interaction (Sub-study 1)', 'orgStudyIdInfo': {'id': '2023-00741a'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults with DGBI', 'description': 'Adults with DGBI, and clinically meaningful symptom levels of anxiety and/or depression'}, {'label': 'Healthcare professionals', 'description': 'Healthcare professionals (physicians, psychologists, nurses, and dietitians).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Örebro', 'country': 'Sweden', 'facility': 'Örebro University', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'overallOfficials': [{'name': 'Inês A Trindade, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Örebro University, Sweden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This question is under investigation. Some of our data contain sensitive information on health, and the main priority is participants integrity which need to be balanced against basic scientific principles on scrutiny. However, any personal data that can be shared without compromising participants integrity to a reasonable degree will be shared upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Örebro University, Sweden', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uppsala University', 'class': 'OTHER'}, {'name': 'SahlgrenskaUniversityHospital', 'class': 'UNKNOWN'}, {'name': 'Göteborg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}