Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2025-12-28 @ 6:28 AM
Study NCT ID:
NCT07025161
Status:
RECRUITING
Last Update Posted:
2025-06-17
First Post:
2025-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brief Mindfulness Intervention for Patients at a Free Acute Care Clinic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-04-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-16', 'studyFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2025-06-16', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Unpleasantness Numeric Rating Scale', 'timeFrame': 'Immediately before to after 4-minute audio recording', 'description': 'Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'Change in Pain Intensity Numeric Rating Scale', 'timeFrame': 'Immediately before to after 4-minute audio recording', 'description': 'Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.'}, {'measure': 'Change in Anxiety Numeric Rating Scale', 'timeFrame': 'Immediately before to after 4-minute audio recording', 'description': 'Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing severe anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded mindfulness intervention for 100 English-speaking patients and 100 Spanish-speaking patients at a free acute care clinic will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥18\n* Seeking treatment at the Shepherd's Hope Downtown Clinic\n\nExclusion Criteria:\n\n* Cognitive impairment preventing completion of study procedures.\n* Other unstable illness judged by medical staff to interfere with study involvement."}, 'identificationModule': {'nctId': 'NCT07025161', 'briefTitle': 'Brief Mindfulness Intervention for Patients at a Free Acute Care Clinic', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': "Brief Behavioral Intervention for Pain (Shepherd's Hope)", 'orgStudyIdInfo': {'id': "STUDY00004916 Shepherd's Hope"}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pain Coping Information', 'description': 'Participants will be randomized to listen to a 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).', 'interventionNames': ['Behavioral: Pain Coping Information']}, {'type': 'EXPERIMENTAL', 'label': 'Mindful Pain Management', 'description': 'Participants will be randomized to listen to a 4-minute audio recording consisting of a 1-minute introduction to mindfulness followed by a 1-minute and 30-second mindful breathing practice and a 1-minute and 30-second mindfulness of pain practice.', 'interventionNames': ['Behavioral: Mindful Pain Management']}], 'interventions': [{'name': 'Pain Coping Information', 'type': 'BEHAVIORAL', 'description': 'A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).', 'armGroupLabels': ['Pain Coping Information']}, {'name': 'Mindful Pain Management', 'type': 'BEHAVIORAL', 'description': 'A 4-minute audio recording consisting of a 1-minute introduction to mindfulness followed by a 1-minute and 30-second mindful breathing practice and a 1-minute and 30-second mindfulness of pain practice.', 'armGroupLabels': ['Mindful Pain Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32805', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Shepherd's Hope Downtown Clinic", 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'centralContacts': [{'name': 'Adam Hanley', 'role': 'CONTACT', 'email': 'adam.hanley@fsu.edu', 'phone': '850-645-9557'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All our data is aggregate and anonymous.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Adam Hanley', 'investigatorAffiliation': 'Florida State University'}}}}