Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT07298018
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RISE for Nurse Managers Retreat
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D000068376', 'term': 'Compassion Fatigue'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D005222', 'term': 'Mental Fatigue'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000073397', 'term': 'Occupational Stress'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-12-11', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maslach Burnout Inventory - Human Services Survey', 'timeFrame': 'Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up', 'description': '22-item questionnaire with the following response categories: 0=never, 1=a few times a year or less, 2=once a month or less, 3=a few times a month, 4=once a week, 5=a few times a week, 6=every day'}], 'secondaryOutcomes': [{'measure': 'Professional Quality of Life Scale', 'timeFrame': 'Baseline, 1- and 3-and 6-month follow-up', 'description': '30-item questionnaire with the following response categories: 1=never, 2=rarely, 3=sometimes, 4=often, 5=very often'}, {'measure': 'Brief Resilience Scale', 'timeFrame': 'Baseline, 1- and 3-and 6-month follow-up', 'description': '6-item questionnaire with the following response categories: 1=strongly agree, 2=disagree, 3=neutral, 4=agree, 5=strongly agree'}, {'measure': 'Self-Reflection and Insight Scale', 'timeFrame': 'Baseline, 1- and 3-and 6-month follow-up', 'description': '20-item questionnaire with the following response categories: 1=strongly disagree, 2, 3, 4, 5, 6=strongly agree'}, {'measure': 'Self-Compassion Scale Short Form', 'timeFrame': 'Baseline, 1- and 3-and 6-month follow-up', 'description': '12-item questionnaire with the following response categories: 1=almost never, 2, 3, 4, 5=almost always'}, {'measure': 'General Self-Efficacy Scale', 'timeFrame': 'Baseline, 1- and 3-and 6-month follow-up', 'description': '10-item questionnaire with the following response categories: 1=not at all true, 2=barely true, 3=moderately true, 4=exactly true'}, {'measure': 'Perceived Stress Scale', 'timeFrame': 'Baseline, 1- and 3-and 6-month follow-up', 'description': '10-item questionnaire with the following response categories: 0=never, 1=almost never, 2=sometimes, 3=fairly often, 4=very often'}, {'measure': 'Generalized Anxiety Disorder - 2 item scale', 'timeFrame': 'Baseline, 1- and 3-and 6-month follow-up', 'description': '2-item questionnaire with the following response categories: 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day'}, {'measure': 'Patient Health Questionnaire - 2 item', 'timeFrame': 'Baseline, 1- and 3-and 6-month follow-up', 'description': '2-item scale with the following response categories: 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day'}, {'measure': 'Post-Traumatic Growth Inventory', 'timeFrame': 'Baseline, 1- and 3-and 6-month follow-up', 'description': '21-item scale scored using six-point responses: zero ("I did not experience this change as a result of my crisis") to five ("I experienced this change to a very great degree as a result of my crisis")'}, {'measure': 'Psychological Empowerment Instrument', 'timeFrame': 'Baseline, 1- and 3-and 6-month follow-up', 'description': '12-item measure that assesses empowerment in the workplace using a 7-point Likert response scale. Four aspects are measured: meaning, competence, self-determination, and impact.'}, {'measure': 'Employment Status', 'timeFrame': '12-month post-program', 'description': 'Human Resources Data'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burnout, Secondary Traumatic Stress, Perceived Stress']}, 'referencesModule': {'references': [{'pmid': '34154451', 'type': 'BACKGROUND', 'citation': 'Bailey AK, Sawyer AT, Robinson PS. A Psychoeducational Group Intervention for Nurses: Rationale, Theoretical Framework, and Development. J Am Psychiatr Nurses Assoc. 2023 May-Jun;29(3):232-240. doi: 10.1177/10783903211001116. Epub 2021 Jun 22.'}, {'pmid': '6668417', 'type': 'BACKGROUND', 'citation': 'Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.'}, {'pmid': '17339617', 'type': 'BACKGROUND', 'citation': 'Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.'}, {'pmid': '14583691', 'type': 'BACKGROUND', 'citation': 'Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.'}, {'pmid': '35873252', 'type': 'BACKGROUND', 'citation': 'Litz BT, Plouffe RA, Nazarov A, Murphy D, Phelps A, Coady A, Houle SA, Dell L, Frankfurt S, Zerach G, Levi-Belz Y; Moral Injury Outcome Scale Consortium. Defining and Assessing the Syndrome of Moral Injury: Initial Findings of the Moral Injury Outcome Scale Consortium. Front Psychiatry. 2022 Jul 5;13:923928. doi: 10.3389/fpsyt.2022.923928. eCollection 2022.'}, {'type': 'BACKGROUND', 'citation': 'Maslach C, Jackson SE, Leiter MP. Maslach Burnout Inventory manual, 3rd ed. Palo Alto, CA: Consulting Psychologists Press, 1996.'}, {'pmid': '21584907', 'type': 'BACKGROUND', 'citation': 'Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.'}, {'pmid': '34293934', 'type': 'BACKGROUND', 'citation': 'Sawyer AT, Bailey AK, Green JF, Sun J, Robinson PS. Resilience, Insight, Self-Compassion, and Empowerment (RISE): A Randomized Controlled Trial of a Psychoeducational Group Program for Nurses. J Am Psychiatr Nurses Assoc. 2023 Jul-Aug;29(4):314-327. doi: 10.1177/10783903211033338. Epub 2021 Jul 23.'}, {'pmid': '37297639', 'type': 'BACKGROUND', 'citation': 'Sawyer AT, Tao H, Bailey AK. The Impact of a Psychoeducational Group Program on the Mental Well-Being of Unit-Based Nurse Leaders: A Randomized Controlled Trial. Int J Environ Res Public Health. 2023 Jun 2;20(11):6035. doi: 10.3390/ijerph20116035.'}, {'type': 'BACKGROUND', 'citation': "Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy Scale. J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs, 35, 37."}, {'pmid': '18696313', 'type': 'BACKGROUND', 'citation': 'Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.'}, {'type': 'BACKGROUND', 'citation': 'Spreitzer GM. Psychological empowerment in the workplace: Dimensions, measurement, and validation. Academy of Management Journal. 1995; 38(5):1442-1465.'}, {'type': 'BACKGROUND', 'citation': 'Stamm, B. H. (2010). Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL). http://www.proqol.org.'}, {'pmid': '8827649', 'type': 'BACKGROUND', 'citation': 'Tedeschi RG, Calhoun LG. The Posttraumatic Growth Inventory: measuring the positive legacy of trauma. J Trauma Stress. 1996 Jul;9(3):455-71. doi: 10.1007/BF02103658.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the feasibility and acceptability of the RISE for Nurse Managers retreat and its impact on occupational and psychological well-being indicators', 'detailedDescription': 'The RISE program is an empirically supported wellbeing intervention for nurses and nurse leaders delivered over 8 or 9 weeks in 90-minute weekly sessions facilitated by a licensed mental health professional. The program themes are Resilience, Insight, Self-Compassion, and Empowerment. This study will be to examine the feasibility and acceptability of delivering the program in a retreat style format over 2.5 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* an employed AdventHealth Nurse Manager\n* a "moderate" or "high" score in burnout equal to ≥17 in the Emotional Exhaustion Domain and/or ≥7 in the Depersonalization Domain on the MBI\n\nExclusion Criteria:\n\n* a direct care RN, Nurse Director, Educator, and Executive\n* a "low" score in burnout equal to \\<17 in the Emotional Exhaustion domain and/or \\<7 in the Depersonalization domain on the MBI'}, 'identificationModule': {'nctId': 'NCT07298018', 'briefTitle': 'RISE for Nurse Managers Retreat', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'A Pilot Study of RISE for Nurse Managers Retreat', 'orgStudyIdInfo': {'id': '2365808'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participant group', 'description': 'Intervention group will attend the RISE Retreat program, which is a 2.5-day retreat-style psychoeducational group program facilitated by licensed mental health professionals (LMHPs)', 'interventionNames': ['Behavioral: Intervention Group']}], 'interventions': [{'name': 'Intervention Group', 'type': 'BEHAVIORAL', 'description': 'Psychoeducational group program designed to impact occupational and psychological indicators including resilience, insight, self-compassion, empowerment, burnout and secondary trauma', 'armGroupLabels': ['Participant group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'centralContacts': [{'name': 'Amanda T. Sawyer, PhD', 'role': 'CONTACT', 'email': 'Amanda.Sawyer@AdventHealth.com', 'phone': '407-200-2901'}, {'name': 'Amy West, RN', 'role': 'CONTACT', 'email': 'Amy.West@AdventHealth.com'}], 'overallOfficials': [{'name': 'Amanda T. Sawyer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AdventHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}