Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-29 @ 12:21 AM
Study NCT ID:
NCT06169293
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-13
First Post:
2023-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an Interactive Mental Wellness (I-AM-WELL) Program on Final Year Nursing Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001522', 'term': 'Behavior, Animal'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2023-12-01', 'studyFirstSubmitQcDate': '2023-12-05', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resilience', 'timeFrame': 'Before training', 'description': 'Brief Resilience Scale'}, {'measure': 'Resilience', 'timeFrame': 'Immediately after training', 'description': 'Brief Resilience Scale'}, {'measure': 'Depression, Anxiety and Stress', 'timeFrame': 'Before training', 'description': 'Depression, Anxiety and Stress Scale - 21'}, {'measure': 'Depression, Anxiety and Stress', 'timeFrame': 'Immediately after training', 'description': 'Depression, Anxiety and Stress Scale - 21'}, {'measure': 'Practice Readiness', 'timeFrame': 'Before training', 'description': 'Nursing Practice Readiness Scale'}, {'measure': 'Practice Readiness', 'timeFrame': 'Immediately after training', 'description': 'Nursing Practice Readiness Scale'}, {'measure': 'Physical Activity', 'timeFrame': 'Before training', 'description': 'International Physical Activity Questionnaire'}, {'measure': 'Physical Activity', 'timeFrame': 'Immediately after training', 'description': 'International Physical Activity Questionnaire'}, {'measure': 'Eating behaviours', 'timeFrame': 'Before training', 'description': 'Self-regulation of eating behaviours scale'}, {'measure': 'Eating behaviours', 'timeFrame': 'Immediately after training', 'description': 'Self-regulation of eating behaviours scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Resilience', 'Practice Readiness', 'Depression', 'Anxiety', 'Stress', 'Physical Activity', 'Eating Behavior']}, 'descriptionModule': {'briefSummary': "This study aims to address the following research questions:\n\nEvaluate the effectiveness of an Interactive Mental Wellness (I-AM-WELL) program on final year nursing students' anxiety, depression, stress, resilience, practice readiness, physical activity and eating behaviours.\n\nExplore final year nursing students' experiences and perception of the I-AM-WELL program.\n\nParticipants will be invited to participate in an asynchronous online I-AM-WELL program"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Final year nursing students enrolled in the undergraduate nursing program\n* Above the ages of 18 years\n* Able to comprehend the English language\n* Have a device that can connect to the Internet\n\nExclusion Criteria:\n\n* Students who refused to participate in the study'}, 'identificationModule': {'nctId': 'NCT06169293', 'acronym': 'I-AM-WELL', 'briefTitle': 'Evaluation of an Interactive Mental Wellness (I-AM-WELL) Program on Final Year Nursing Students', 'organization': {'class': 'OTHER', 'fullName': 'National University of Singapore'}, 'officialTitle': 'Evaluation of an Interactive Mental Wellness (I-AM-WELL) Program on Final Year Nursing Students: A Mixed Methods Evaluation', 'orgStudyIdInfo': {'id': 'NUS-IRB-2023-641'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I-AM-WELL program', 'interventionNames': ['Behavioral: I-AM-WELL']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control', 'description': 'Students will receive the intervention after data is collected from all three time points'}], 'interventions': [{'name': 'I-AM-WELL', 'type': 'BEHAVIORAL', 'description': 'The I-AM-WELL program adopts an asynchronous online learning approach and will be delivered over one week by a trained counsellor, and a nurse researcher.\n\nStudents will attend an online self-paced program. The program will comprise of topics such as: (1) Resilience and protective factors, (2) introduction to clinical nursing education, (3) experiences of clinical attachments, and (4) stress, physical wellbeing and diet materials. Students will have access to online materials (e.g., short videos), have opportunities to discuss (e.g., forum) and infographics.\n\nOverall, the program will be delivered over in one week lasting six hours.', 'armGroupLabels': ['I-AM-WELL program']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Darryl Ang, PhD', 'role': 'CONTACT', 'email': 'darrylang@nus.edu.sg', 'phone': '66011298'}], 'overallOfficials': [{'name': 'Darryl Ang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University of Singapore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}