Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 5:32 PM
Study NCT ID:
NCT07472127
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Professional Readiness Through Emotional Preparedness (PREP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm, quasi-experimental study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 212}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PsyCap Questionnaire-24 (PCQ-24)', 'timeFrame': 'Baseline, 5-month, 8-month, 11-month', 'description': '24-item questionnaire with the following response options: 1=strongly disagree, 2=disagree, 3=somewhat disagree, 4=somewhat agree, 5=agree, 6=strongly agree. Total raw score ranges from 24 to 144 and the overall score is calculated as a mean, with higher scores corresponding to greater psychological capital. The four subscales are Hope, Efficacy, Resilience, and Optimism and each contain 6 items which are averaged.'}], 'secondaryOutcomes': [{'measure': 'Work Readiness Scale for Graduate Nurses (WRS-GN)', 'timeFrame': 'Baseline, 5-month, 8-month, 11-month', 'description': '46-item questionnaire with response options on a 10-point Likert Scale (1=completely disagree and 10=completely agree). Total scale scores range from 46-460, with higher score indicating higher work readiness. The four domains of work readiness are work competence, social intelligence, organizational acumen, and personal work characteristics'}, {'measure': 'Professional Quality of Life Scale', 'timeFrame': 'Baseline, 5-month, 8-month, 11-month', 'description': '30-item questionnaire with the following response options: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Very Often. There are 3 domains, and each domain includes 10 of the 30 total items. A sum of 22 or less on any domain = score of 43 or less = indicating a low level; a sum of 23-41 = score of 50 = average level; sum of 42 or more = score of 57+ = high level.'}, {'measure': 'Self-Compassion scale - Short-Form', 'timeFrame': 'Baseline, 5-month, 8-month, 11-month', 'description': '12-item questionnaire with response options on a 5-point Likert scale (1=almost never, 2, 3, 4, 5=almost always). The sum of the items ranges from 12-60 with higher scores indicating higher self-compassion. Average scores are categorized as 1-2.5 = low self-compassion, 2.5-3.5 = moderate self-compassion, and 3.5-5 = high self-compassion'}, {'measure': 'Generalized Anxiety Disorder (GAD-2)', 'timeFrame': 'Baseline, 5-month, 8-month, 11-month', 'description': '2-item questionnaire with the following response options: 0=not at all, 1-several days, 2=more than half the days, 3=nearly every day. Total score ranges from 0 to 6. A score of 0-2 indicates minimal anxiety while a score of 3 or greater indcates possible anxiety.'}, {'measure': 'Patient Health Questionnaire (PHQ-2)', 'timeFrame': 'Baseline, 5-month, 8-month, 11-month', 'description': '2-item questionnaire with the following response options: 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Total score ranges from 0 to 6. A score of 0-1 indicates minimal or no depressive symptoms, score of 2-3 indicates mild depressive symptoms, and a score 4-6 indicates moderate to severe depressive symptoms.'}, {'measure': 'Employment status', 'timeFrame': '12, 18, and 24-months', 'description': "Verification of participant's current employment status at AdventHealth from human resources data will be verified at 12, 18, and 24 months."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burnout']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'An M, Heo S, Hwang YY, Kim J, Lee Y. Factors affecting turnover intention among new graduate nurses: focusing on job stress and sleep disturbance. Healthcare. 2022; 10(6): 1122.'}, {'type': 'BACKGROUND', 'citation': 'Avey JB, Reichard RJ, Luthans F, Mhatre KH. Meta-analysis of the impact of positive psychological capital on employee attitudes, behaviors, and performance. Human resource development quarterly. 2011; 22(2): 127-152.'}, {'type': 'BACKGROUND', 'citation': 'Carter JW, Youssef-Morgan C. Psychological capital development effectiveness of face-to-face, online, and Micro-learning interventions. Education and Information Technologies. 2022;27(5): 6553-6575.'}, {'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.'}, {'type': 'BACKGROUND', 'citation': 'Dudasova L, Prochazka J, Vaculik M, Lorenz T. Measuring psychological capital: Revision of the compound psychological capital scale (CPC-12). PloS one. 2021;16(3): e0247114.'}, {'type': 'BACKGROUND', 'citation': 'Edwards-Maddox S. Burnout and impostor phenomenon in nursing and newly licensed registered nurses: A scoping review. Journal of clinical nursing. 2023;32(5-6): 653-665.'}, {'type': 'BACKGROUND', 'citation': 'Grant AM, Franklin J, Langford P. The Self-Reflection and Insight Scale: A new measure of private self-consciousness. Social Behavior and Personality. 2002;30(8):821-836'}, {'type': 'BACKGROUND', 'citation': 'Grubaugh ML, Africa L, Loresto Jr FL. Exploring the relationship between psychological capital and turnover among new nurses. Nurse Leader. 2023;21(3): 409-414.'}, {'type': 'BACKGROUND', 'citation': 'Ho HC, Chan YC. Flourishing in the workplace: A one-year prospective study on the effects of perceived organizational support and psychological capital. International Journal of Environmental Research and Public Health. 2022;19(2): 922.'}, {'type': 'BACKGROUND', 'citation': 'Jarden RJ, Jarden A, Weiland TJ, Taylor G, Bujalka H, Brockenshire N, Gerdtz MF. New graduate nurse wellbeing, work wellbeing and mental health: A quantitative systematic review. International journal of nursing studies. 2021;121: 103997.'}, {'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.'}, {'type': 'BACKGROUND', 'citation': 'Lupșa D, Vîrga D, Maricuțoiu LP, Rusu A. Increasing psychological capital: A pre-registered meta-analysis of controlled interventions. Applied Psychology. 2020; 69(4): 1506-1556.'}, {'type': 'BACKGROUND', 'citation': 'Luthans F, Avey JB, Avolio BJ, Peterson SJ. The development and resulting performance impact of positive psychological capital. Human resource development quarterly. 2010; 21(1): 41-67.'}, {'type': 'BACKGROUND', 'citation': 'Masso M, Sim J, Halcomb E, Thompson C. Practice readiness of new graduate nurses and factors influencing practice readiness: A scoping review of reviews. International Journal of Nursing Studies. 2022; 129: 104208.'}, {'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.'}, {'type': 'BACKGROUND', 'citation': 'Reebals C, Wood T, Markaki A. Transition to practice for new nurse graduates: Barriers and mitigating strategies. Western Journal of Nursing Research. 2022; 44(4): 416-429.'}, {'type': 'BACKGROUND', 'citation': 'Schaufeli WB, Leiter MP, Maslach C. Burnout: 35 years of research and practice. Career development international. 2009;14(3):204-220.'}, {'type': 'BACKGROUND', 'citation': 'See ECW, Koh SSL, Baladram S, Shorey S. Role transition of newly graduated nurses from nursing students to registered nurses: a qualitative systematic review. Nurse Education Today. 2023; 121: 105702.'}, {'type': 'BACKGROUND', 'citation': 'Stamm BH. (2010). Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL). http://www.proqol.org.'}, {'type': 'BACKGROUND', 'citation': 'Walker A, Storey KM, Costa BM, Leung RK. Refinement and validation of the Work Readiness Scale for graduate nurses. Nursing outlook. 2015; 63(6): 632-638. https://doi.org/10.1016/j.outlook.2015.06.001'}, {'type': 'BACKGROUND', 'citation': 'Wang J, Chen J, Zheng L, Zeng B, Yan X, Xia M, et al. Influence of psychological capital on core competency for new nurses. PLoS ONE. 2023; 18(8): e0289105. https://doi.org/10.1371/journal.pone.0289105'}, {'type': 'BACKGROUND', 'citation': 'World Health Organization. Burnout an "occupational phenomenon": International Classification of Diseases. https://www.who.int/mental_health/evidence/burn-out/en/ Published May 28, 2019.'}, {'type': 'BACKGROUND', 'citation': 'Xing L, Lu Y, Zhang H, Shi Z, Chang S, Liu W, Zhang H. Mediating effect of psychological capital on the relationship between mental health literacy and coping styles among newly recruited nurses. BMC nursing. 2024; 23(1): 178.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to examine the impact of the PREP program on participants' psychological and occupational well-being, and work readiness", 'detailedDescription': 'This study will examine the impact of 5-month educational workshop series Professional Readiness through Emotional Preparedness (PREP) embedded within existing nurse residency programs. The PREP program will focus on knowledge acquisition and skill development in mindfulness, intentional recovery, emotional agility, self-compassion, mental health literacy, empowerment, and mindful self-care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nurse resident employed by AdventHealth working in acute care/hospital setting\n* Able to speak, read, and understand English\n* Able to provide informed consent\n* Willing and able to comply with study procedures and requirements for duration of study\n\nExclusion Criteria:\n\n* Not in a current RN residency program\n* Unwilling or unable to comply with all study procedures and requirements for the duration of the study'}, 'identificationModule': {'nctId': 'NCT07472127', 'acronym': 'PREP', 'briefTitle': 'Professional Readiness Through Emotional Preparedness (PREP)', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'Professional Readiness Through Emotional Preparedness (PREP): A Quasi-experimental Study of a Workshop Series for Newly Licensed Nurses in Residency Programs', 'orgStudyIdInfo': {'id': '2392003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PREP program', 'description': 'Professional Readiness through Emotional Preparedness (PREP) program added to existing nurse residency curriculum', 'interventionNames': ['Behavioral: Professional Readiness through Emotional Preparedness (PREP) program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Existing nurse residency curriculum'}], 'interventions': [{'name': 'Professional Readiness through Emotional Preparedness (PREP) program', 'type': 'BEHAVIORAL', 'description': '5-month educational workshop series', 'armGroupLabels': ['PREP program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'centralContacts': [{'name': 'Amanda T Sawyer, PhD', 'role': 'CONTACT', 'email': 'Amanda.Sawyer@AdventHealth.com', 'phone': '407-200-2901'}], 'overallOfficials': [{'name': 'Amanda T Sawyer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AdventHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}