Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-28 @ 6:40 PM
Study NCT ID:
NCT06986850
Status:
RECRUITING
Last Update Posted:
2025-05-23
First Post:
2025-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FeelSync: Tailoring Ecological Momentary Assessments and Interventions for Emotion Awareness, Regulation, and Mental Health Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007802', 'term': 'Language'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 490}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-05-15', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Stress Scale', 'timeFrame': 'Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)', 'description': 'Self-report questionnaire, Range: 0 - 40 Higher scores: Worse outcome (higher perceived stress)'}, {'measure': 'Beck Depression Inventory II', 'timeFrame': 'Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)', 'description': 'Self-report questionnaire, Range: 0 - 63 Higher scores: Worse outcome (more severe depressive symptoms)'}, {'measure': 'State-Trait Anxiety Inventory', 'timeFrame': 'Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)', 'description': 'Self-report questionnaire, \\[state scale only\\], Range: 20 - 80 Higher scores: Worse outcome (greater state anxiety)'}, {'measure': 'Emotion Regulation Questionnaire', 'timeFrame': 'Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)', 'description': 'Self-report questionnaire, Reappraisal subscale: Range 1 - 7 (mean of 6 items) Higher scores: Better outcome (more frequent use of cognitive reappraisal) Suppression subscale: Range 1 - 7 (mean of 4 items) Higher scores: Worse outcome (more frequent use of suppression)'}, {'measure': 'Cognitive Emotion Regulation Questionnaire', 'timeFrame': 'Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)', 'description': 'Self-report questionnaire, Subscale range: 2 - 10 per strategy\n\nHigher scores:\n\nOn adaptive strategies (e.g., positive reappraisal, putting into perspective): Better outcome On maladaptive strategies (e.g., rumination, catastrophizing): Worse outcome'}, {'measure': 'Toronto Alexithymia Scale', 'timeFrame': 'Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)', 'description': 'Self-report questionnaire, Range: 20 - 100 Higher scores: Worse outcome (greater difficulties in identifying and describing feelings; lower emotional awareness)'}], 'secondaryOutcomes': [{'measure': 'Mobile Agnew Relationship Measure', 'timeFrame': 'Follow-up (post intervention, study day 9)', 'description': 'Self-report questionnaire, Range: 16-112 Higher scores: Better outcome (stronger perceived therapeutic alliance with the app/intervention)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ecological momentary assessment', 'ecological momentary intervention', 'language', 'cognitive reappraisal', 'emotion regulation', 'emotion awareness', 'mental health'], 'conditions': ['Stress']}, 'descriptionModule': {'briefSummary': 'This study investigates how different ways of reflecting on emotions in daily life influence emotional awareness, emotion regulation, and mental health. Using the FeelSync mobile app over the course of seven days, participants are prompted multiple times a day to report on their current emotional state in various formats (e.g., rating scales, multiple choice, or free text). In some groups, participants also receive brief daily exercises designed to help them practice cognitive reappraisal-a strategy that involves reframing stressful situations to reduce their emotional impact. The study aims to assess not only the overall effectiveness of these reappraisal exercises but also whether the type of emotional self-report used before the intervention affects its impact. All participants complete questionnaires before and after the app phase to track changes in mood, stress, emotional awareness, and regulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Owning a smartphone\n* Proficiency in English language\n* Being a student\n* Age between 18 to 30 years old\n\nExclusion Criteria:\n\n\\- Severe mental health disorder'}, 'identificationModule': {'nctId': 'NCT06986850', 'acronym': 'FeelSync', 'briefTitle': 'FeelSync: Tailoring Ecological Momentary Assessments and Interventions for Emotion Awareness, Regulation, and Mental Health Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus University Rotterdam'}, 'officialTitle': 'FeelSync: Tailoring Ecological Momentary Assessments and Interventions for Emotion Awareness, Regulation, and Mental Health Outcomes', 'orgStudyIdInfo': {'id': 'ETH2425-0653'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ecological Momentary Assessment with self-generated emotion description', 'description': "Ecological Momentary Assessment with participant's self-generated emotion description in an open-ended question form, in English, provided five times daily for seven consecutive days", 'interventionNames': ['Device: Ecological Momentary Assessment mobile application']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ecological Momentary Assessment with pre-defined set of emotion items to select', 'description': 'Ecological Momentary Assessment with pre-defined set of emotion items to select in a multiple-choice question form, in English, provided five times daily for seven consecutive days', 'interventionNames': ['Device: Ecological Momentary Assessment mobile application']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ecological Momentary Assessment with pre-defined set of emotion items to rate on a Likert scale', 'description': 'Ecological Momentary Assessment with pre-defined set of emotion items to rate on a seven-point Likert scale, in a slider form, in English, provided five times daily for seven consecutive days', 'interventionNames': ['Device: Ecological Momentary Assessment mobile application']}, {'type': 'EXPERIMENTAL', 'label': 'Ecological Momentary Intervention with self-generated emotion description', 'description': "Ecological Momentary Intervention focused on cognitive reappraisal, with a possibility to choose between distancing and positive reappraisal, provided three times daily and preceded by Ecological Momentary Assessment with participant's self-generated emotion description in an open-ended question form, in English, provided five times daily for seven consecutive days", 'interventionNames': ['Device: FeelSync mobile application']}, {'type': 'EXPERIMENTAL', 'label': 'Ecological Momentary Intervention with self-generated emotion description in mother tongue', 'description': "Ecological Momentary Intervention focused on cognitive reappraisal, with a possibility to choose between distancing and positive reappraisal, provided three times daily and preceded by Ecological Momentary Assessment with participant's self-generated emotion description in an open-ended question form, in participant's mother tongue, provided five times daily for seven consecutive days", 'interventionNames': ['Device: FeelSync mobile application']}, {'type': 'EXPERIMENTAL', 'label': 'Ecological Momentary Intervention with pre-defined set of emotion items to select', 'description': 'Ecological Momentary Intervention focused on cognitive reappraisal, with a possibility to choose between distancing and positive reappraisal, provided three times daily and preceded by Ecological Momentary Assessment with pre-defined set of emotion items to rate on a seven-point Likert scale, in a slider form, in English, provided five times daily for seven consecutive days', 'interventionNames': ['Device: FeelSync mobile application']}, {'type': 'EXPERIMENTAL', 'label': 'Ecological Momentary Intervention with pre-defined set of emotion items to rate on a Likert scale', 'description': 'Ecological Momentary Intervention focused on cognitive reappraisal, with a possibility to choose between distancing and positive reappraisal, provided three times daily and preceded by Ecological Momentary Assessment with pre-defined set of emotion items to rate on a seven-point Likert scale, in a slider form, in English, provided five times daily for seven consecutive days', 'interventionNames': ['Device: FeelSync mobile application']}], 'interventions': [{'name': 'FeelSync mobile application', 'type': 'DEVICE', 'description': 'Ecological Momentary Intervention focused on cognitive reappraisal for distressing autobiographical memories, with a possibility to choose between distancing and positive reappraisal.', 'armGroupLabels': ['Ecological Momentary Intervention with pre-defined set of emotion items to rate on a Likert scale', 'Ecological Momentary Intervention with pre-defined set of emotion items to select', 'Ecological Momentary Intervention with self-generated emotion description', 'Ecological Momentary Intervention with self-generated emotion description in mother tongue']}, {'name': 'Ecological Momentary Assessment mobile application', 'type': 'DEVICE', 'description': 'Ecological Momentary Assessment used for self-monitoring of emotional states.', 'armGroupLabels': ['Ecological Momentary Assessment with pre-defined set of emotion items to rate on a Likert scale', 'Ecological Momentary Assessment with pre-defined set of emotion items to select', 'Ecological Momentary Assessment with self-generated emotion description']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marta A Marciniak, Dr', 'role': 'CONTACT', 'email': 'marciniak@essb.eur.nl', 'phone': '+31 10 754 5276'}], 'facility': 'Erasmus University Rotterdam', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Marta A Marciniak, Dr', 'role': 'CONTACT', 'email': 'marciniak@essb.eur.nl', 'phone': '+31 10 754 5276'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ANALYTIC_CODE'], 'timeFrame': '09/2025-09/2035', 'ipdSharing': 'YES', 'description': 'Only anonymized data from the self-report questionnaires will be shared via Open Science Framework.', 'accessCriteria': 'Anyone will be able to access anonymized participant data from self-report questionnaires.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marta Marciniak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Marta Marciniak', 'investigatorAffiliation': 'Erasmus University Rotterdam'}}}}