Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-01-07 @ 3:45 AM
Study NCT ID:
NCT05383157
Status:
RECRUITING
Last Update Posted:
2025-03-27
First Post:
2022-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brief Mindfulness Intervention for Chronic Pain in Ukraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'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': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2022-05-16', 'studyFirstSubmitQcDate': '2022-05-16', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Decentering', 'timeFrame': 'Change from baseline to 20 minutes later.', 'description': 'Three items from the The Metacognitive Processes of Decentering Scale rated on a numeric rating scale ranging from 0-10, with 0 indicating no decentering and 10 representing very high levels of decentering.'}, {'measure': 'Self-transcendence', 'timeFrame': 'Change from baseline to 20 minutes later.', 'description': 'Three items from the Nondual Awareness Dimensional Assessment rated on a numeric rating scale ranging from 0-10, with 0 indicating no transcendence and 10 representing very high levels of transcendence.'}], 'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Change from baseline to 20 minutes later.', 'description': 'Single numeric rating scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'Pain unpleasantness', 'timeFrame': 'Change from baseline to 20 minutes later.', 'description': 'Single numeric rating scale ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.'}, {'measure': 'Positive affect', 'timeFrame': 'Change from baseline to 20 minutes later.', 'description': 'Single numeric rating scale ranging from 0-10, with 0 indicating no positive affect and 10 representing very high levels of positive affect.'}, {'measure': 'Desire for analgesic medication', 'timeFrame': 'Change from baseline to 20 minutes later.', 'description': 'Single numeric rating scale ranging from 0-10, with 0 indicating no medication desire and 10 representing very high levels of medication desire.'}, {'measure': 'Anxiety', 'timeFrame': 'Change from baseline to 20 minutes later.', 'description': 'Single numeric rating scale ranging from 0-10, with 0 indicating no anxiety and 10 representing very high levels of anxiety.'}, {'measure': 'Depression', 'timeFrame': 'Change from baseline to 20 minutes later.', 'description': 'Single numeric rating scale ranging from 0-10, with 0 indicating no depression and 10 representing very high levels of depression.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'This is a pragmatic randomized controlled trial comparing a single 15-minute mindfulness-based intervention to usual care for patients with chronic pain in Ukraine being seen in a pain clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician-confirmed chronic pain-related diagnosis\n\nExclusion Criteria:\n\n* Cognitive impairment preventing completion of study procedures.\n* Other unstable illness judged by medical staff to interfere with study treatment.'}, 'identificationModule': {'nctId': 'NCT05383157', 'briefTitle': 'Brief Mindfulness Intervention for Chronic Pain in Ukraine', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Brief Mindfulness Intervention for Chronic Pain in Ukraine', 'orgStudyIdInfo': {'id': '0122U002551'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brief mindfulness', 'description': 'A 15-minute mindfulness intervention integrating mindful breathing and mindfulness of pain techniques.', 'interventionNames': ['Behavioral: Brief mindfulness', 'Other: Usual care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': '15 minutes of usual chronic pain care delivered in an academic pain clinic environment.', 'interventionNames': ['Other: Usual care']}], 'interventions': [{'name': 'Brief mindfulness', 'type': 'BEHAVIORAL', 'description': 'Training in mindfulness focused on breathing and pain sensations to enhance decentering, meta-awareness, and interoceptive awareness.', 'armGroupLabels': ['Brief mindfulness']}, {'name': 'Usual care', 'type': 'OTHER', 'description': 'Usual pain care as delivered in the clinic involving pain assessment and prescription of analgesics.', 'armGroupLabels': ['Brief mindfulness', 'Usual care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vinnitsa', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Dmytro Dmytriiev', 'role': 'CONTACT'}], 'facility': 'Vinnitsa National Medical University', 'geoPoint': {'lat': 49.84639, 'lon': 37.71861}}], 'centralContacts': [{'name': 'Dmytro Dmytriiev, MD', 'role': 'CONTACT', 'email': 'mddmytriiev@gmail.com', 'phone': '380-432-570-360'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vinnitsa National Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Distinguished Professor', 'investigatorFullName': 'Eric Garland', 'investigatorAffiliation': 'University of Utah'}}}}