Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-24 @ 4:56 PM
Study NCT ID:
NCT06806150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The INSPIRE Study: INvestigation of Swiss Physicians Inner-life, Resilience, and Emotions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002055', 'term': 'Burnout, Professional'}, {'id': 'D000097815', 'term': 'Emotional Exhaustion'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D005221', 'term': 'Fatigue'}, {'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'], 'maskingDescription': 'Participants: Control participants are aware of the trial but do not know they are assigned to the control arm, as they are treated as part of the larger cohort and do not receive the intervention.\n\nInvestigators: Investigators are masked because recruitment and assignment are automated, ensuring they do not know which participants are in the intervention or control arms.\n\nOutcome Assessors: Researchers analyzing the data remain blinded to group allocation to minimize bias in data interpretation.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-01-31', 'studyFirstSubmitQcDate': '2025-01-31', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Perceived impact of the INSPIRE Interventions', 'timeFrame': 'Within 6 months post-intervention', 'description': 'Qualitative interviews with a subset of trial participants to understand perceived impact of the INSPIRE interventions.'}, {'measure': 'Acceptability of the INSPIRE Interventions', 'timeFrame': 'Within 6 months post-intervention', 'description': 'Qualitative interviews with a subset of trial participants to understand acceptability of the INSPIRE interventions.'}], 'primaryOutcomes': [{'measure': 'Change from baseline in Emotional Exhaustion', 'timeFrame': '3 months post-intervention', 'description': 'Emotional Exhaustion subscale of the MBI-HSS'}], 'secondaryOutcomes': [{'measure': 'Change in Emotional Exhaustion', 'timeFrame': 'Baseline to 2 weeks, 1 month, 6 months, 1 year', 'description': 'Emotional Exhaustion subscale of the MBI-HSS'}, {'measure': 'Change in Depersonalization', 'timeFrame': 'Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year', 'description': 'Depersonalization subscale of the MBI-HSS'}, {'measure': 'Change in Personal Accomplishment', 'timeFrame': 'Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year', 'description': 'Personal accomplishment subscale of the MBI-HSS'}, {'measure': 'Change in Physician wellbeing', 'timeFrame': 'Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year', 'description': 'Physician Wellness Inventory (PWI)'}, {'measure': 'Change in Job Satisfaction', 'timeFrame': 'Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year', 'description': 'Physician Job Satisfaction Scale'}, {'measure': 'Change in comfort with End-of-Life Communication', 'timeFrame': 'Baseline to 1 month, 3 months, 6 months, 1 year', 'description': 'Communication about End of Life Survey'}, {'measure': 'Change in Mindfulness', 'timeFrame': 'Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year', 'description': 'Mindful Attention Awareness Scale (MAAS-Trait)'}, {'measure': 'Change in Compassionate Care', 'timeFrame': 'Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year', 'description': 'Santa Clara Brief Compassion Scale'}, {'measure': 'Change in Emotion Regulation', 'timeFrame': 'Baseline to 1 month, 3 months, 6 months, 1 year', 'description': 'Emotion Regulation Questionnaire (ERQ)'}, {'measure': 'Change in Positive and Negative Affect', 'timeFrame': 'Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year', 'description': 'Positive and Negative Affect Schedule (PANAS)'}, {'measure': 'Change in Authenticity', 'timeFrame': 'Baseline to 3 months, 6 months, 1 year', 'description': 'Inauthenticity Scale'}, {'measure': 'Resilience', 'timeFrame': 'Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year', 'description': '2-item Connor-Davidson resilience scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychological resilience', 'Positive Psychology'], 'conditions': ['Burnout, Professional', 'Emotional Exhaustion', 'Emotions', 'Wellness, Psychological', 'Satisfaction, Personal']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial, nested within an observational cohort study, is to evaluate whether two positive psychology web-based interventions can reduce emotional exhaustion and improve overall well-being in practicing physicians in Switzerland. The main questions it aims to answer are:\n\nDoes participation in positive psychology interventions reduce emotional exhaustion at three months post-intervention? How do these interventions impact physician wellness, job satisfaction, comfort with end-of-life communication and other aspects of physicians' emotional well-being?\n\nResearchers will compare the effects of two intervention arms (general reflection vs. work-specific reflection) to a control group to determine whether focusing on work-specific aspects leads to greater improvements in emotional exhaustion and job-related outcomes.\n\nParticipants will:\n\n* Complete an 8-day intervention consisting of positive psychology activities delivered online.\n* Complete baseline and follow-up assessments over the study period", 'detailedDescription': 'Burnout, emotional exhaustion, and moral distress are widespread among physicians, negatively impacting patient care, job satisfaction, and physician retention in the workforce. While interventions targeting burnout exist, many require significant time commitments or institutional support, limiting accessibility.\n\nPositive psychology interventions, which emphasize strengths-based approaches such as self-reflection, gratitude, and self-compassion, have shown promise in enhancing resilience and well-being.\n\nThe INSPIRE study is a randomized controlled trial (RCT) nested within an observational cohort using a Trial within Cohort (TwiC) design. It evaluates two web-based positive psychology interventions aimed at reducing emotional exhaustion and improving physician well-being.\n\nA subset of cohort participants is randomized into one of three arms: a control group, a general life reflection intervention, or a work-focused reflection intervention. The interventions consist of an 8-day structured self-reflection program delivered online.\n\nThe study employs automated randomization, triple masking (participants, investigators, and outcome assessors), and longitudinal assessments over one year. Findings will inform the scalability of low-burden interventions for physician burnout prevention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'This study is open to all gender identities, including male, female, non-binary, and those who prefer not to disclose it.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be a practicing physician in Switzerland\n2. Working at least 40% in a clinical capacity\n3. Be willing and able to provide informed consent\n4. Expecting to be professionally active until 2028\n\nExclusion Criteria:\n\n1. Retired physician or physician seeking retirement within 3 years from first participation in the study\n2. Physician unable to participate in one of the study languages: English, German, or French'}, 'identificationModule': {'nctId': 'NCT06806150', 'acronym': 'INSPIRE', 'briefTitle': 'The INSPIRE Study: INvestigation of Swiss Physicians Inner-life, Resilience, and Emotions', 'organization': {'class': 'OTHER', 'fullName': 'University of Bern'}, 'officialTitle': 'The INSPIRE Study: INvestigation of Swiss Physicians Inner-life, Resilience, and Emotions', 'orgStudyIdInfo': {'id': '2023-00963'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention 1 - General Positive Psychology Reflection', 'description': 'Participants engage in an 8-day web-based intervention involving positive psychology exercises focused on general life situations.', 'interventionNames': ['Behavioral: INSPIRE Life Reflection']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention 2 - Work-Specific Positive Psychology Reflection', 'description': 'Participants engage in the same 8-day web-based intervention, but the focus is specifically on positive reflections related to work and patient interactions.', 'interventionNames': ['Behavioral: INSPIRE Work Reflection']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants complete assessments but do not receive the intervention.'}], 'interventions': [{'name': 'INSPIRE Life Reflection', 'type': 'BEHAVIORAL', 'description': 'An 8-day web-based positive psychology intervention encouraging participants to reflect on positive aspects of their daily lives. Activities include gratitude exercises, self-compassion writing, and recognizing meaningful moments.', 'armGroupLabels': ['Intervention 1 - General Positive Psychology Reflection']}, {'name': 'INSPIRE Work Reflection', 'type': 'BEHAVIORAL', 'description': 'An 8-day web-based positive psychology intervention encouraging participants to reflect on positive aspects of their work experiences. Activities include gratitude exercises, self-compassion writing, and recognizing meaningful professional interactions.', 'armGroupLabels': ['Intervention 2 - Work-Specific Positive Psychology Reflection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3012', 'city': 'Bern', 'country': 'Switzerland', 'contacts': [{'name': 'Sofia C Zambrano, PhD', 'role': 'CONTACT', 'email': 'sofia.zambrano@unibe.ch'}, {'name': 'Robert Staeck, MSc', 'role': 'CONTACT', 'email': 'robert.staeck@unibe.ch'}, {'name': 'Sofia C Zambrano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'centralContacts': [{'name': 'Sofia C Zambrano, PhD', 'role': 'CONTACT', 'email': 'sofia.zambrano@unibe.ch', 'phone': '+41 31 684 57 76'}, {'name': 'Robert Staeck, MSc', 'role': 'CONTACT', 'email': 'robert.staeck@unibe.ch'}], 'overallOfficials': [{'name': 'Sofia C Zambrano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bern'}]}, 'ipdSharingStatementModule': {'timeFrame': '18 months after publication of primary results and will remain accessible for at least 5 years', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) will be made available for research purposes upon request. Data will include survey responses and outcome measures but will exclude any personally identifiable information', 'accessCriteria': 'Researchers can request access by submitting a proposal to the study investigators. Access will be granted to qualified researchers for scientifically valid analyses, subject to data-sharing agreements and ethical considerations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}