Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-01-04 @ 12:05 PM
Study NCT ID:
NCT06537258
Status:
RECRUITING
Last Update Posted:
2025-03-14
First Post:
2024-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Rate Variability and Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2024-08-01', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in psychological distress', 'timeFrame': 'Baseline, 6 weeks post-intervention', 'description': 'A continuous composite measure of stress, anxiety, and depression. Which will be analyzed continuously to evaluate for a significant mean difference between randomized groups at study endpoint (6-weeks). Scores range from 0 to 63, with higher scores indicating greater distress.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cognitive behavioral therapy', 'heart rate variability'], 'conditions': ['Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': 'The goals of this study are to test the effectiveness of a virtually delivered, group-based coping skills treatment program incorporating heart rate variability biofeedback to target autonomic dysfunction in youth diagnosed with inflammatory bowel disease (IBD). The investigators will enroll participants with IBD in a biofeedback enhanced cognitive behaviorally based coping skills treatment. Participants will be randomized to biofeedback enhanced treatment or wait-list control.', 'detailedDescription': "The goals of this study are to test the effectiveness of a virtually delivered, group-based coping skills treatment program incorporating heart rate variability biofeedback to target autonomic dysfunction in youth diagnosed with inflammatory bowel disease (IBD).\n\nPatients are youth ages 13-18 recruited through IBD clinics at Children's Healthcare of Atlanta. Enrollment will include up to 128 children with at least 1 parent. This study will last 7-months and will have 4 in person study visits, lasting about 1 hour each, as well as 6 virtual treatment sessions lasting about 45 minutes each.\n\nStudy procedures will include surveys, chart/record review, blood sampling, and non-invasive assessments of psychophysiological functioning. Stool samples will be collected and stored. Informed consent and assent will be obtained in-person or remote signed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis with biopsy-confirmed IBD for at least 4 months,\n* ages 13 through 18 years inclusive,\n* speak English,\n* enrolling with at least 1 parent/guardian who is willing to participate by completing surveys,\n* positive depression or anxiety screens using the PHQ-4, - access to home internet to participate in virtual intervention,\n* youth and parent agree to the conditions of study participation, including randomization, participation in intervention, and follow-up assessments,\n* youth is medically approved to engage in normal daily activities (e.g., attend school, extracurricular activities)\n\nExclusion Criteria:\n\n* previous diagnosis of developmental disabilities that require full-time special education or that impair the ability to respond to treatment,\n* diagnosis with any other chronic disease (e.g., diabetes, epilepsy, etc.),\n* diagnosis of abnormal thyroid function,\n* treatment with any drug with known autonomic cardiovascular influences including beta-blockers, central sympatholytic agents, or antidepressants.'}, 'identificationModule': {'nctId': 'NCT06537258', 'briefTitle': 'Heart Rate Variability and Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'A Heart Rate Variability Biofeedback Enhanced Behavioral Intervention to Improve Psychological and Disease Functioning in Youth With Inflammatory Bowel Disease (IBD)', 'orgStudyIdInfo': {'id': 'STUDY00007611'}, 'secondaryIdInfos': [{'id': 'R01DK139653-01', 'link': 'https://reporter.nih.gov/quickSearch/R01DK139653-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biofeedback Enhanced Treatment', 'description': 'Participants in this group will participate in biofeedback enhanced cognitive behaviorally based coping skills treatment. Treatment will consist of a 6-visit group intervention conducted online, via Emory zoom. Groups will include 5-8 patients. Groups will meet approximately each week for 6 weeks. Patients will also rate their disease symptoms and measures of clinical disease activity will be collected via chart review. Clinical assessments will occur at baseline within 1 week prior to starting treatment (T1), at treatment end or 6 weeks after baseline (T2), 14 weeks after baseline to capture 2-month follow-up after treatment (T3) and at 26 weeks after baseline (T4).', 'interventionNames': ['Behavioral: Biofeedback Enhanced Treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list control', 'description': 'Participants randomized to the waitlist control group will complete the same assessment protocol at the time of randomization (Baseline) and again 6 weeks later. They will then be invited to begin treatment and will repeat the assessments at posttest and again at 14 and 26-week follow-up (for a total of 5 assessments).'}], 'interventions': [{'name': 'Biofeedback Enhanced Treatment', 'type': 'BEHAVIORAL', 'otherNames': ['biofeedback cognitive behaviorally based coping skills treatment'], 'description': 'At all 4 assessment points (T1-T4), HRV will be measured using the ECG module of the mobile MindWare system at a sampling rate of 500 Hz, and a Skin Conductance Response (SCR) will be collected at a sampling rate of 10 Hz using eSense for iPad. Electrodes to assess SCR and HRV will be attached to patients during an \\~10-minute period.\n\nA 5-minute initial baseline assessment will occur first followed by three 5-minute stress trials.\n\nStress tasks will be audio recorded to measure study fidelity, and participants will be asked to rate their subjective level of stress with each trial. At all assessment points (T1-T4), participants will be provided with stool collection kits to collect a stool sample within 3 days of the laboratory psychophysiological assessment.\n\nAt all assessment points (T1-T4), a blood draw of approximately 3 ml of blood will be collected.', 'armGroupLabels': ['Biofeedback Enhanced Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bonney Reed, PhD', 'role': 'CONTACT', 'email': 'ebreed@emory.edu'}], 'facility': 'Atlanta Metropolitan Area', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bonney Reed, PhD', 'role': 'CONTACT', 'email': 'ebreed@emory.edu'}, {'name': 'Bonney Reed, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bonney Reed, PhD', 'role': 'CONTACT', 'email': 'ebreed@emory.edu'}, {'name': 'Bonney Reed, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center for Advanced Pediatrics', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'centralContacts': [{'name': 'Bonney Reed, PhD', 'role': 'CONTACT', 'email': 'ebreed@emory.edu', 'phone': '404-727-8312'}], 'overallOfficials': [{'name': 'Bonney Reed, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 3 months and ending 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'Data will be shared with Researchers who provide a methodologically sound proposal. The research team will share individual participant data that underlie the results reported in a published article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': 'Proposals should be directed to ebreed@emory.edu To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website, Vivli.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Bonney Reed', 'investigatorAffiliation': 'Emory University'}}}}