Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
Study NCT ID:
NCT04693728
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2020-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adaptive Strategies for Resilient Intrinsic Self-Regulation in Extremes (RISE)
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': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-30', 'studyFirstSubmitDate': '2020-12-23', 'studyFirstSubmitQcDate': '2020-12-30', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RAND 36-item Health Survey (SF-36) - Mental Health and Physical Health subscales', 'timeFrame': '2 weeks', 'description': 'assessment of positive emotional health'}, {'measure': 'PTSD Check List-5', 'timeFrame': '2 weeks', 'description': 'assessment of PTSD symptoms'}, {'measure': 'Patient Health Questionnaire, Depression Scale (PHQ-9)', 'timeFrame': '2 weeks', 'description': 'assessment of depression symptoms'}, {'measure': 'Generalized Anxiety Disorder (GAD-7)', 'timeFrame': '2 weeks', 'description': 'assessment of anxiety symptoms'}, {'measure': 'Pain Catastrophizing Scale', 'timeFrame': '2 weeks', 'description': 'assessment of pain catastrophizing symptoms'}, {'measure': 'Physical Symptoms Scale (PHQ-15)', 'timeFrame': '2 weeks', 'description': 'assessment of physical symptoms'}, {'measure': 'Insomnia Severity Index', 'timeFrame': '2 weeks', 'description': 'assessment of insomnia symptoms'}, {'measure': 'West Haven-Yale Multidimensional Pain Inventory (WYMPI)', 'timeFrame': '2 weeks', 'description': 'multidimensional assessment of pain'}, {'measure': 'Pain Outcomes Questionnaire (POQ)', 'timeFrame': '2 weeks', 'description': 'multidimensional assessment of pain'}, {'measure': 'Neuropsychological Assessment Battery (NAB) - Word Generation subtest', 'timeFrame': '2 weeks', 'description': 'neuropsychological assessment of executive functions'}, {'measure': 'Delis-Kaplan Executive Function System (D-KEFS) - Category Fluency, Category Switching, and Color-Word Switching subtests', 'timeFrame': '2 weeks', 'description': 'neuropsychological assessement'}, {'measure': 'Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)', 'timeFrame': '2 weeks', 'description': 'neuropsychological assessment of working memory, episodic memory, and complex attention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '33912102', 'type': 'DERIVED', 'citation': 'Kent M, Mardian AS, Regalado-Hustead ML, Gress-Smith JL, Ciciolla L, Kim JL, Scott BA. Adaptive Homeostatic Strategies of Resilient Intrinsic Self-Regulation in Extremes (RISE): A Randomized Controlled Trial of a Novel Behavioral Treatment for Chronic Pain. Front Psychol. 2021 Apr 12;12:613341. doi: 10.3389/fpsyg.2021.613341. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of a resilience intervention in Veterans with chronic pain compared to wait list control.', 'detailedDescription': 'After being consented and screened for eligibility, participants completed baseline assessments and then were randomized to either the study intervention or wait list control. Participants who were randomized to the study intervention completed post testing assessment measures within two weeks of the final treatment. Participants who were randomized to waitlist conditions completed post testing assessment measures within 2 weeks of the end of the waitlist condition and then subsequently received the study intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.18-80 years of age 2. United States Veterans from the conflicts of OEF/OIF to Vietnam era 3. Self-identified chronic pain or chart diagnosis of chronic pain\n\nExclusion Criteria:\n\n1. Active suicidality of suicidal intent requiring a greater than outpatient level of care (Columbia Suicidality Rating Scale screen, C-SSRS)\n2. Active alcohol abuse (Alcohol Use Disorder Identification Test, AUDIT-C)\n3. Active psychosis (Psychosis Screener)\n4. Current severe disabling illness\n5. Inability to participate in a small group interactive setting\n6. Inability to meet attendance requirement\n7. Neurocognitive conditions other than TBI (e.g. dementia, Parkinsons, stroke)\n8. Concurrently receiving Exposure Therapy, Cognitive Behavior Therapy, Acceptance and Commitment Therapy'}, 'identificationModule': {'nctId': 'NCT04693728', 'acronym': 'RISE', 'briefTitle': 'Adaptive Strategies for Resilient Intrinsic Self-Regulation in Extremes (RISE)', 'organization': {'class': 'FED', 'fullName': 'Phoenix VA Health Care System'}, 'officialTitle': 'Adaptive Strategies for Resilient Intrinsic Self-Regulation in Extremes (RISE): A Controlled Clinical Trial as an Intervention for Chronic Pain From a Homeostatic Perspective', 'orgStudyIdInfo': {'id': '1054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Behavioral Intervention', 'description': 'The study intervention arm was a behavioral treatment that consisted of training resilient intrinsic self-regulation strategies to help alleviate chronic pain.', 'interventionNames': ['Behavioral: Resilient Intrinsic Self-Regulation Strategies in Extremes']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list with no treatment', 'description': 'The control comparison arm consisted of a wait-list condition in which participants received no treatment during a time interval comparable to the intervention arm.'}], 'interventions': [{'name': 'Resilient Intrinsic Self-Regulation Strategies in Extremes', 'type': 'BEHAVIORAL', 'otherNames': ['Active Intervention arm'], 'description': 'The manualized intervention covered resilience strategies organized into four modules: (1) engagement, (2) social relatedness, (3) transformation of pain and (4) building a good life. The modules were delivered in 8 weekly sessions of 90 minutes each.', 'armGroupLabels': ['Behavioral Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix VA Health Care System', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Martha Kent, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Phoenix VAHCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phoenix VA Health Care System', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Research Scientist', 'investigatorFullName': 'Aram Mardian', 'investigatorAffiliation': 'Phoenix VA Health Care System'}}}}