Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-25 @ 2:06 PM
Study NCT ID:
NCT04523766
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2020-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing the Impact of Mindful Interoceptive Mapping and Mindful Breathing on Pain and Opioid Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-11-26', 'releaseDate': '2024-11-08'}, {'resetDate': '2024-12-18', 'releaseDate': '2024-11-26'}, {'resetDate': '2025-01-09', 'releaseDate': '2024-12-18'}], 'estimatedResultsFirstSubmitDate': '2024-11-08'}}, '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2020-08-19', 'studyFirstSubmitQcDate': '2020-08-19', 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immediate Change in Pleasant Sensation Ratios', 'timeFrame': 'Immediately before and immediately after the final mindfulness training session, approximately 30 minutes', 'description': 'The Multidimensional Assessment of Pleasant and Painful Sensations (MAPPS) is an outline of a human body overlaid by a grid of 786 sensation pixels that was developed using the Qualtrics online survey platform, which can be recreated on any device capable of supporting a web-browser. Mouse clicks allow respondents to identify locations (i.e., grid pixels) on the manikin where they feel both pleasant and unpleasant sensations. Clicking once in any grid pixel turns that location blue, indicating a pleasant sensation. Clicking twice in any grid pixel turns that location red, indicating an unpleasant sensation. A ratio of pleasant to unpleasant sensations is derived from MAPPS.'}, {'measure': 'Longer-Term Change in Pleasant Sensation Ratios', 'timeFrame': 'At baseline and posttreatment, approximately 1.5 months', 'description': 'The Multidimensional Assessment of Pleasant and Painful Sensations (MAPPS) is an outline of a human body overlaid by a grid of 786 sensation pixels that was developed using the Qualtrics online survey platform, which can be recreated on any device capable of supporting a web-browser. Mouse clicks allow respondents to identify locations (i.e., grid pixels) on the manikin where they feel both pleasant and unpleasant sensations. Clicking once in any grid pixel turns that location blue, indicating a pleasant sensation. Clicking twice in any grid pixel turns that location red, indicating an unpleasant sensation. A ratio of pleasant to unpleasant sensations is derived from MAPPS.'}], 'secondaryOutcomes': [{'measure': 'Change in Opioid Medication Desire', 'timeFrame': 'Immediately before and immediately after the final mindfulness training session, approximately 30 minutes', 'description': 'Single-item Numeric Rating Scale (0-10), with 0 indicating no desire for opioid medication and 10 representing the an intense desire for opioid medication.'}, {'measure': 'Change in Pain Intensity', 'timeFrame': 'Immediately before and immediately after the final mindfulness training session, approximately 30 minutes', 'description': 'Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the an most intense pain imaginable.'}, {'measure': 'Change in Opioid Use', 'timeFrame': 'At baseline and 1-month follow-up, approximately 3 months', 'description': 'Opioid Use will be assessed with a timeline follow-back procedure.'}, {'measure': 'Change in Pain Functional Interference', 'timeFrame': 'At pretreatment and 1-month follow-up, approximately 3 months', 'description': 'Pain functional interference will be assessed with the Brief Pain Inventory.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Chronic', 'Opioid Use']}, 'descriptionModule': {'briefSummary': "This is a single site, two-arm, parallel group randomized clinical trial comparing the effect of two mindfulness-based interventions (Mindful Interoceptive Mapping vs. Mindfulness of the Breath) on opioid-treated chronic pain patients' pleasant/unpleasant sensation reports and opioid use."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) men/women ≥18 years of age,\n* (2) current chronic low back pain condition determined by physician assessment (e.g., ICD-10 codes M54.5, M54.4, M54.3),\n* (3) reporting pain ≥3 on 0-10 scale with opioid medication, and\n* (4) long-term opioid pharmacotherapy (\\>3 months of use).\n\nExclusion Criteria:\n\n* (1) formal mindfulness training (e.g., MBSR/MBRP),\n* (2) current cancer diagnosis,\n* (3) psychosis, suicidality, and moderate/severe substance use disorder in the past year as assessed with the MINI, and\n* (4) unstable illness, as judged by a physician, that may interfere with treatment.'}, 'identificationModule': {'nctId': 'NCT04523766', 'briefTitle': 'Comparing the Impact of Mindful Interoceptive Mapping and Mindful Breathing on Pain and Opioid Use', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Enhancing Pain Management and Preventing Opioid Misuse by Optimizing Mindfulness Based Interventions for Opioid-Treated Chronic Pain Patients: A Comparison of Mindful Interoceptive Mapping and Mindful Breathing', 'orgStudyIdInfo': {'id': 'IRB_00135443'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness of Breath', 'interventionNames': ['Behavioral: Mindfulness of Breath']}, {'type': 'EXPERIMENTAL', 'label': 'Mindful Interoceptive Mapping', 'interventionNames': ['Behavioral: Mindful Interoceptive Mapping']}], 'interventions': [{'name': 'Mindfulness of Breath', 'type': 'BEHAVIORAL', 'description': 'The Mindful Breathing intervention will be adapted from a validated, brief mindfulness training model. Participants will be instructed to focus on the sensations of the breath (i.e., at the tip of the nose and in the nostrils, abdomen and back) and, if a pain arises in the body, acknowledge it without judgement and return attention to the breath.', 'armGroupLabels': ['Mindfulness of Breath']}, {'name': 'Mindful Interoceptive Mapping', 'type': 'BEHAVIORAL', 'description': "The MIM intervention will be adapted from the core MORE meditation practice. Participants will be instructed to (1) zoom in to deconstruct pain into its constituent affectively-valenced physical sensations and precisely map each sensation's spatial location, (2) zoom out to broaden the field of attention to include previously neglected sensory elements (i.e., spaces within the body that are absent of sensation and pleasant sensations), and (3) savor any pleasant sensations or experiences occurring during the mindfulness practice.", 'armGroupLabels': ['Mindful Interoceptive Mapping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Adam Hanley', 'investigatorAffiliation': 'University of Utah'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-11-08', 'type': 'RELEASE'}, {'date': '2024-11-26', 'type': 'RESET'}, {'date': '2024-11-26', 'type': 'RELEASE'}, {'date': '2024-12-18', 'type': 'RESET'}, {'date': '2024-12-18', 'type': 'RELEASE'}, {'date': '2025-01-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Adam Hanley, Assistant Professor, University of Utah'}}}}