Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-01 @ 3:56 PM
Study NCT ID:
NCT05085132
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2021-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Efficacy Trial of the MindFi App for Stress, Well-being, and Sleep Quality in Working Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized in a 1:1 allocation to use the MindFi app or receive a dummy version of the app (containing music tracks for relaxation).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2021-09-22', 'studyFirstSubmitQcDate': '2021-10-15', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WHO Well-Being Index (WHO, 1998)', 'timeFrame': 'Week 0 (at the start of the intervention) and Week 5', 'description': 'Change in self-reported mental well being (min score: 0; max score: 25; greater increases in this score represent a better outcome)'}, {'measure': 'Depression, Anxiety, And Stress Scale -- Stress subscale (Lovibond and Lovibond, 1985)', 'timeFrame': 'Week 0 (at the start of the intervention) and Week 5', 'description': 'Change in self-report measure of stress (min score: 0; max score: 21; greater reductions in this score represent a better outcome)'}, {'measure': 'Change in Sleep Efficiency (Oura Ring)', 'timeFrame': 'Week 0 (at the start of the intervention) and Week 5', 'description': '(Latency + wake time)/Time in bed, as calculated by the Oura app'}], 'secondaryOutcomes': [{'measure': 'Depression, Anxiety, And Stress Scale -- Depression subscale (Lovibond and Lvibond, 1985)', 'timeFrame': 'Week 0 (at the start of the intervention) and Week 5', 'description': 'Change in Self-report measure of depression (min score: 0; max score: 21; greater reductions in this score represent a better outcome)'}, {'measure': 'Depression, Anxiety, And Stress Scale -- Anxiety subscale (Lovibond and Lvibond, 1985)', 'timeFrame': 'Week 0 (at the start of the intervention) and Week 5', 'description': 'Change in Self-report measure of anxiety (min score: 0; max score: 21; greater reductions in this score represent a better outcome)'}, {'measure': 'Maslach Burnout Inventory (Maslach et al., 1996)', 'timeFrame': 'Week 0 (at the start of the intervention) and Week 5', 'description': 'Change in self-report measure of burnout\n\n3 subscales:\n\n1. Emotional exhaustion (min score: 0; max score: 54; greater reductions in this score represent a better outcome)\n2. Depersonalization (min score: 0; max score: 30; greater reductions in this score represent a better outcome)\n3. Personal achievement (min score: 0; max score: 48; greater increases in this score represent a better outcome)'}, {'measure': 'Five Factor Mindfulness Questionnaire (Baer et al., 2006)', 'timeFrame': 'Week 0 (at the start of the intervention) and Week 5', 'description': 'Change in Self-report measure of trait mindfulness (min score: 39; max score: 195; greater increases in this score represent a better outcome)'}, {'measure': 'Brief Inventory of Thriving (Su et al., 2014)', 'timeFrame': 'Week 0 (at the start of the intervention) and Week 5', 'description': 'Change in Self-report measure of eudaimonic well-being (min score: 10; max score: 50; greater increases in this score represent a better outcome)'}, {'measure': 'Resting heart rate during sleep (from Oura Ring)', 'timeFrame': 'Week 0 (at the start of the intervention) and Week 5', 'description': 'Objective measure of resting heart rate'}, {'measure': 'Heart-rate variability during sleep (from Oura Ring)', 'timeFrame': 'Week 0 (at the start of the intervention) and Week 5', 'description': 'Objective measure of heart rate variability'}, {'measure': 'Satisfaction with Life Scale (Diener et al., 1985)', 'timeFrame': 'Week 0 (at the start of the intervention) and Week 5', 'description': 'Self-report measure of hedonic well being (min score: 5; max score: 35; greater increases in this score represent a better outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness', 'Sleep quality', 'Well-being'], 'conditions': ['Stress', 'Burnout']}, 'descriptionModule': {'briefSummary': '90% of Asian workers report high levels of stress in an "always-on" culture. Stress and burnout are risk factors that account for 10-20% of health expenditure and threaten work longevity in the world\'s fastest growing economies. Traditional face-to-face sources of mental care such as counseling and psychotherapy are effective as a countermeasure to stress, but not always accessible or acceptable for those with busy lifestyles. Because of this, there is an urgent need for on-demand, scalable interventions to reduce stress and improve mental and physical well being. Technology-based solutions are increasingly being proposed to fill this need.\n\nMindFi is a smartphone app that uses mindfulness exercises to help users cope with work stress and increase productivity. Since 2017, it has been featured by Apple, BBC, and Bloomberg and is being used at corporates such as Bain, Bloomberg, Cigna, and Zendesk. MindFi users contribute behavioral and self-report data, which are then used to generate individual recommendations for relevant, evidence-based exercises. These include mental care techniques such as mindfulness meditation, therapeutic journaling, psychosocial support and educational wellbeing quizzes.\n\nIn this study, the investigators will recruit 200 participants in a randomized controlled design, with 100 receiving access to content of the MindFi app, and 100 receiving access to a version containing music tracks for relaxation. Each intervention will last 4 weeks. Participants will use these apps for a period of 5 weeks (for a minimum of 10 minutes per day). Pre- and post-intervention, the investigators will measure self-reported ratings on a number of psychological variables, and will track sleep quality objectively for a one-week period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Currently in full-time employment\n2. Fluent in English\n3. DASS-21 scores of at least 10 on the Stress subscale\n\nExclusion Criteria:\n\n1. Current diagnosis of a chronic psychological disorder, or sleep disorder\n2. Regularly practising meditation'}, 'identificationModule': {'nctId': 'NCT05085132', 'briefTitle': 'An Efficacy Trial of the MindFi App for Stress, Well-being, and Sleep Quality in Working Adults', 'organization': {'class': 'OTHER', 'fullName': 'National University of Singapore'}, 'officialTitle': 'An Efficacy Trial of the MindFi App for Stress, Well-being, and Sleep Quality in Working Adults', 'orgStudyIdInfo': {'id': 'MINDFI01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MindFi app: Standard content', 'description': 'Participants will receive full access to the MindFi app, containing learning tracks, practice tracks, and assessments. Participants will be instructed to use a practice track for a minimum of 10 minutes a day, and may use other exercises or tracks if desired. The intervention will last 4 weeks.', 'interventionNames': ['Behavioral: MindFi app: Standard content']}, {'type': 'SHAM_COMPARATOR', 'label': 'Mindfi app: Standard content without practice', 'description': 'Participants will receive full access to the MindFi app, containing learning tracks, music tracks, and assessments. Participants will be instructed to use a music track for a minimum of 10 minutes a day, and may use other exercises or tracks if desired. The intervention will last 4 weeks.', 'interventionNames': ['Behavioral: Mindfi app: Standard content without practice']}], 'interventions': [{'name': 'MindFi app: Standard content', 'type': 'BEHAVIORAL', 'description': 'Digital wellness training in this study will be delivered via the MindFi app, designed by Jaedye Labs. Content includes learning, assesesment, and practice tracks A core component of the exercises in this app is mindfulness training; however, the app also incorporates other exercises drawn from positive psychology such as journaling and diaphragmatic breathing. The app goes beyond traditional guided meditation through content that reinforces the principles and attitudes taught during in-person training, and also seeks to maximize user experience by using interactive tasks and progress charts.', 'armGroupLabels': ['MindFi app: Standard content']}, {'name': 'Mindfi app: Standard content without practice', 'type': 'BEHAVIORAL', 'description': 'In this condition, participants will receive a version of the MindFi app that does NOT contain the practice tracks, only the learning and assessment tracks.', 'armGroupLabels': ['Mindfi app: Standard content without practice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119077', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Julian Lim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University of Singapore'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ICF', 'ANALYTIC_CODE'], 'timeFrame': 'The data will become available after publication into perpetuity.', 'ipdSharing': 'YES', 'description': 'De-identified IPD will be shared with other researchers upon reasonable request, and after publication of the study results,', 'accessCriteria': 'Researchers with a reasonable re-analysis plan will be eligible for data sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Singapore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jaedye Labs', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Julian Lim', 'investigatorAffiliation': 'National University of Singapore'}}}}