Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-05 @ 6:33 PM
Study NCT ID:
NCT06483568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral Mechanisms and Health Outcomes of Positive Psychological Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Participants will not be aware of whether their activities are considered the active or control activities as both will be described as self-improvement activities. The PI and all research staff interacting with participants will not be aware of their condition assignment.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to complete positive psychology intervention activities or procedure-matched activities related to personal organization.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-28', 'studyFirstSubmitDate': '2024-04-26', 'studyFirstSubmitQcDate': '2024-06-28', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Life Satisfaction', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Satisfaction with Life Scale, 1-7 scale, higher scores better'}, {'measure': 'Positive Affect', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Scale of Positive and Negative Affect, 1-5 scale, higher scores better'}, {'measure': 'Negative Affect', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Scale of Positive and Negative Affect, 1-5 scale, lower scores better'}, {'measure': 'Meaning in Life', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Meaning in Life Questionnaire, 1-7 scale, higher scores better'}, {'measure': 'Optimism', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Life Orientation Test-Revised, 1-5 scale, higher scores better'}, {'measure': 'Perceived General Health', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Medical Outcomes Study (MOS) Short Form Health Survey (SF-36), General Health Perceptions Subscale, 1-5, higher scores better'}, {'measure': 'Blood Pressure', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Systolic and Diastolic Blood Pressure In-lab measurement with OMRON 10 Series Wireless Upper Arm Blood Pressure Monitor'}, {'measure': 'Heart Rate', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'In-lab measurement with OMRON 10 Series Wireless Upper Arm Blood Pressure Monitor'}, {'measure': 'Peak Expiratory Flow Rate', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'In-lab measurement with EasyOne Air Spirometer'}, {'measure': 'Grip Strength', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'In-lab measurement with Jamar Plus+ Digital Hand Dynamometer'}, {'measure': 'Momentary Mood', 'timeFrame': '3x daily; weeks 1-8, 19, 20', 'description': 'Rate your current mood. 1 (very bad) to 7 (very good), higher scores better'}, {'measure': 'Momentary Meaning in Life', 'timeFrame': '3x daily; weeks 1-8, 19, 20', 'description': 'Daily Meaning Scale, 1-7, higher scores better'}], 'secondaryOutcomes': [{'measure': 'Amusement', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Dispositional Positive Emotions Scale, 1-7, higher scores better'}, {'measure': 'Awe', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Dispositional Positive Emotions Scale, 1-7, higher scores better'}, {'measure': 'Compassion', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Dispositional Positive Emotions Scale, 1-7, higher scores better'}, {'measure': 'Contentment', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Dispositional Positive Emotions Scale, 1-7, higher scores better'}, {'measure': 'Joy', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Dispositional Positive Emotions Scale, 1-7, higher scores better'}, {'measure': 'Love', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Dispositional Positive Emotions Scale, 1-7, higher scores better'}, {'measure': 'Pride', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Dispositional Positive Emotions Scale, 1-7, higher scores better'}, {'measure': 'Hope', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'State Hope Scale, 1-8, higher scores better'}, {'measure': 'Depression', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Patient Health Questionnaire-9, 0-27, lower scores better'}, {'measure': 'Anxiety', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'State-Trait Anxiety Inventory, 1-4, lower scores better'}, {'measure': 'Perceived Stress', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Perceived Stress Scale, 0-4, lower scores better'}, {'measure': 'Loneliness', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'UCLA Loneliness Scale, 1-4, lower scores better'}, {'measure': 'Social Connectedness', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Comprehensive Inventory of Thriving, 1-5, higher scores better'}, {'measure': 'Social Support', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Perceived Social Support Scale, 1-5, higher scores better'}, {'measure': 'Sleep Quality', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'Pittsburgh Sleep Quality Index, 0-21, lower scores better'}, {'measure': 'Cigarette Use', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'cigarette smoking days/month x cigarettes per average smoking day, lower scores better'}, {'measure': 'Tobacco Use (non-cigarette products)', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'tobacco use days/month x average uses per day of using, lower scores better'}, {'measure': 'Alcohol Use', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'days in last month drinking x average number of drinks/drinking day, lower scores better'}, {'measure': 'Vigorous Activity Level', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'International Physical Activity Questionnaire, days/week x minutes/day, higher scores better'}, {'measure': 'Moderate Activity Level', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'International Physical Activity Questionnaire, days/week x minutes/day, higher scores better'}, {'measure': 'Walking', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'International Physical Activity Questionnaire, days/week x minutes/day, higher scores better'}, {'measure': 'Physical Functioning', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'MOS Short Form Health Survey (SF-36), Physical Functioning Subscale, 1-3, higher scores better'}, {'measure': 'Role Functioning--Physical', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'MOS Short Form Health Survey (SF-36), Physical Role Functioning Subscale, 0-4, lower scores better'}, {'measure': 'Role Functioning--Emotional', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'MOS Short Form Health Survey (SF-36), Emotional Role Functioning Subscale, 0-3, lower scores better'}, {'measure': 'Social Functioning', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'MOS Short Form Health Survey (SF-36), Social Functioning Subscale, 0-5, lower scores better'}, {'measure': 'Sitting', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'International Physical Activity Questionnaire, hours/weekday, lower scores better'}, {'measure': 'Bodily Pain', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'MOS Short Form Health Survey (SF-36), Pain Subscale, 2-11, lower scores better'}, {'measure': 'General Mental Health', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'MOS Short Form Health Survey (SF-36), General Mental Health Subscale, 1-6, higher scores better'}, {'measure': 'Vitality', 'timeFrame': 'baseline, immediate post-treatment, 14-week post-treatment follow-up', 'description': 'MOS Short Form Health Survey (SF-36), Vitality Subscale, 1-6, higher scores better'}, {'measure': 'Momentary physical activity', 'timeFrame': '3x daily; weeks 1-8, 19, 20', 'description': 'Physical activity behaviors checklist, 0-3, higher scores better'}, {'measure': 'Momentary tobacco use', 'timeFrame': '3x daily; weeks 1-8, 19, 20', 'description': 'Have you used a tobacco product in the previous 4 hours? 0 (no)/1(yes), lower scores better'}, {'measure': 'Momentary alcohol use', 'timeFrame': '3x daily; weeks 1-8, 19, 20', 'description': 'Have you consumed alcohol in the previous 4 hours? 0 (no)/1(yes), lower scores better'}, {'measure': 'Momentary eating', 'timeFrame': '3x daily; weeks 1-8, 19, 20', 'description': 'Have you eaten \\[fruit or vegetable/sugary dessert, snack, or beverage\\] in the previous 4 hours? 0-2, higher scores better'}, {'measure': 'Momentary connective Behaviors', 'timeFrame': '3x daily; weeks 1-8, 19, 20', 'description': 'Connective behaviors checklist, 0-5, higher scores better'}, {'measure': 'Momentary Stress', 'timeFrame': '3x daily; weeks 1-8, 19, 20', 'description': 'How stressed do you feel right now? 1(not at all) to 7 (very much), lower scores better'}, {'measure': 'Momentary Depression', 'timeFrame': '3x daily; weeks 1-8, 19, 20', 'description': 'How depressed do you feel right now? 1(not at all) to 7 (very much), lower scores better'}, {'measure': 'Momentary Anxiety', 'timeFrame': '3x daily; weeks 1-8, 19, 20', 'description': 'How anxious do you feel right now? 1(not at all) to 7 (very much), lower scores better'}, {'measure': 'Momentary Loneliness', 'timeFrame': '3x daily; weeks 1-8, 19, 20', 'description': 'How lonely do you feel right now? 1(not at all) to 7 (very much), lower scores better'}, {'measure': 'Momentary Perceived General Health', 'timeFrame': '3x daily; weeks 1-8, 19, 20', 'description': 'How do you feel in terms of your physical health right now? 1 (poor) to 5 (excellent), higher scores better'}, {'measure': 'Sleep Quality', 'timeFrame': '1x daily; weeks 1-8, 19, 20', 'description': 'How would you rate the quality of your sleep last night? 1 (very bad) to 4 (very good), higher scores better'}, {'measure': 'Sleep Duration', 'timeFrame': '1x daily; weeks 1-8, 19, 20', 'description': 'Wake up time - (lights out time + time to fall asleep), higher scores better'}, {'measure': 'Common Symptoms Checklist', 'timeFrame': '1x daily; weeks 1-8, 19, 20', 'description': '1-5, lower scores better'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emotional Well-Being', 'Happiness', 'Gratitude', 'Kindness', 'Self-Compassion', 'Capitalization'], 'conditions': ['Well-Being, Psychological']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if engaging in a multi-activity positive psychology intervention increases emotional well-being\n\nThe main aims of this project are to:\n\n1. Test the efficacy of a multi-activity positive psychology intervention for increasing emotional well-being in a racial-ethnically and socioeconomically diverse sample.\n2. Identify physical and social behavioral mechanisms driving positive psychology intervention effects on emotional well-being change and the durability of these effects over time.\n3. Examine physical health outcomes stemming from emotional well-being gains.\n\nParticipants will:\n\nVisit the laboratory three times to complete survey measures and physical assessments.\n\nComplete brief survey items three times a day for 10 weeks of the study period. Engage with assigned activities weekly for four weeks of the study period.', 'detailedDescription': "Participation will span 20 weeks around a four-week treatment phase. Assessments will involve three lab visits and experience sampling method surveys completed on participants' smart phones in response to short message service (SMS) message alerts.\n\nLab Visit 1 (Baseline): Participants will begin participation with an in-person lab visit held in small groups. This visit will begin with a guided informed consent procedure. Participants will complete baseline self-report measures and physiological assessments and receive procedure instructions.\n\nPre-Intervention Monitoring (weeks 1 \\& 2): For two weeks, participants will compete three very brief experience sampling surveys per day.\n\nRandom Assignment, Treatment and Monitoring (weeks 3,4,5,\\& 6): Participants will be randomly assigned to the online four-week Pathways to Happiness treatment condition or a matched activity control condition. All participants will complete the four weeks of activities (either Pathways to Happiness Positive Psychology Intervention (PPI) or control activities) on the Pathways to Happiness platform. They will complete weekly check-in items on the Pathways to Happiness platform to assess their compliance with the activity instructions and their experiences with the activities. Participants in both conditions will continue completing experience sampling surveys during this time.\n\nLab Visit 2 (Post-Test), after week 6: The second lab visit will occur after week six, following the treatment phase. It will involve identical questionnaires and physiological screenings as in the baseline visit.\n\nPost-Intervention Monitoring (weeks 7\\&8): After the treatment phase, two weeks of post-intervention experience sampling survey monitoring will begin.\n\nWaiting Period: Participants will not engage in any formal study activities from weeks 9 to 19.\n\nFollow-Up Monitoring (weeks 19-20): Follow-up experience sampling monitoring will commence for the final two weeks of the study, 10 weeks after the previous monitoring period.\n\nLab Visit 3 (Follow-Up), after week 20: The final lab visit, identical to the others, will occur after week 20 and will conclude with an exit interview regarding participants' experiences in the study and with each PPI activity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fluent or native English speaker capable of completing survey questionnaires in English\n\nExclusion Criteria:\n\n* Major depressive disorder (PHQ-9 \\> or = 15)'}, 'identificationModule': {'nctId': 'NCT06483568', 'briefTitle': 'Behavioral Mechanisms and Health Outcomes of Positive Psychological Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Behavioral Mechanisms and Health Outcomes of Positive Psychological Intervention', 'orgStudyIdInfo': {'id': 'Pro2023002402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Positive Psychology Intervention Activities', 'description': 'Four week intervention with four weekly activities including gratitude journal, random acts of kindness, self-compassionate letter, and capitalizing on positive events activities.', 'interventionNames': ['Behavioral: Pathways to Happiness Intervention']}, {'type': 'SHAM_COMPARATOR', 'label': 'Personal Organization Activities', 'description': 'Control participants will complete procedure-matched activities related to personal organization, including writing in a completed tasks journal, completing a weekly task burst, productivity letter, and talking to others about tasks activities.', 'interventionNames': ['Behavioral: Personal Organization Activities']}], 'interventions': [{'name': 'Pathways to Happiness Intervention', 'type': 'BEHAVIORAL', 'description': 'Four weeks of activities including a gratitude journal, random acts of kindness, self-compassionate letter, and capitalizing on positive events activities.', 'armGroupLabels': ['Positive Psychology Intervention Activities']}, {'name': 'Personal Organization Activities', 'type': 'BEHAVIORAL', 'description': 'Four weeks of activities including a completed tasks journal, weekly "task burst," productivity letter, and talking to others about task activities.', 'armGroupLabels': ['Personal Organization Activities']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data and materials will be shared concurrent with publication and will be available indefinitely on the Open Science Framework.', 'ipdSharing': 'YES', 'description': 'Individual participant data collected during the trial, after deidentification, and the study protocol materials will be shared on the Open Science Framework.', 'accessCriteria': 'Anyone who wishes to access the data will be able to do so'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Samantha J. Heintzelman, PhD', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}