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:
Rutgers, The State University of New Jersey
Organization:
Study Overview
Official Title:
Behavioral Mechanisms and Health Outcomes of Positive Psychological Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if engaging in a multi-activity positive psychology intervention increases emotional well-being
The main aims of this project are to:
1. Test the efficacy of a multi-activity positive psychology intervention for increasing emotional well-being in a racial-ethnically and socioeconomically diverse sample.
2. Identify physical and social behavioral mechanisms driving positive psychology intervention effects on emotional well-being change and the durability of these effects over time.
3. Examine physical health outcomes stemming from emotional well-being gains.
Participants will:
Visit the laboratory three times to complete survey measures and physical assessments.
Complete 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.
The main aims of this project are to:
1. Test the efficacy of a multi-activity positive psychology intervention for increasing emotional well-being in a racial-ethnically and socioeconomically diverse sample.
2. Identify physical and social behavioral mechanisms driving positive psychology intervention effects on emotional well-being change and the durability of these effects over time.
3. Examine physical health outcomes stemming from emotional well-being gains.
Participants will:
Visit the laboratory three times to complete survey measures and physical assessments.
Complete 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.
Detailed Description:
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.
Lab 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.
Pre-Intervention Monitoring (weeks 1 \& 2): For two weeks, participants will compete three very brief experience sampling surveys per day.
Random 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.
Lab 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.
Post-Intervention Monitoring (weeks 7\&8): After the treatment phase, two weeks of post-intervention experience sampling survey monitoring will begin.
Waiting Period: Participants will not engage in any formal study activities from weeks 9 to 19.
Follow-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.
Lab 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.
Lab 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.
Pre-Intervention Monitoring (weeks 1 \& 2): For two weeks, participants will compete three very brief experience sampling surveys per day.
Random 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.
Lab 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.
Post-Intervention Monitoring (weeks 7\&8): After the treatment phase, two weeks of post-intervention experience sampling survey monitoring will begin.
Waiting Period: Participants will not engage in any formal study activities from weeks 9 to 19.
Follow-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.
Lab 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: