Behavioral Mechanisms and Health Outcomes of Positive Psychological Intervention
- Conditions
- Well-Being, Psychological
- Interventions
- Behavioral: Pathways to Happiness InterventionBehavioral: Personal Organization Activities
- Registration Number
- NCT06483568
- Lead Sponsor
- Rutgers, The State University of New Jersey
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 250
- Fluent or native English speaker capable of completing survey questionnaires in English
- Major depressive disorder (PHQ-9 > or = 15)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Positive Psychology Intervention Activities Pathways to Happiness Intervention Four week intervention with four weekly activities including gratitude journal, random acts of kindness, self-compassionate letter, and capitalizing on positive events activities. Personal Organization Activities Personal Organization Activities 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.
- Primary Outcome Measures
Name Time Method Meaning in Life baseline, immediate post-treatment, 14-week post-treatment follow-up Meaning in Life Questionnaire, 1-7 scale, higher scores better
Negative Affect baseline, immediate post-treatment, 14-week post-treatment follow-up Scale of Positive and Negative Affect, 1-5 scale, lower scores better
Positive Affect baseline, immediate post-treatment, 14-week post-treatment follow-up Scale of Positive and Negative Affect, 1-5 scale, higher scores better
Optimism baseline, immediate post-treatment, 14-week post-treatment follow-up Life Orientation Test-Revised, 1-5 scale, higher scores better
Heart Rate baseline, immediate post-treatment, 14-week post-treatment follow-up In-lab measurement with OMRON 10 Series Wireless Upper Arm Blood Pressure Monitor
Momentary Meaning in Life 3x daily; weeks 1-8, 19, 20 Daily Meaning Scale, 1-7, higher scores better
Life Satisfaction baseline, immediate post-treatment, 14-week post-treatment follow-up Satisfaction with Life Scale, 1-7 scale, higher scores better
Blood Pressure baseline, immediate post-treatment, 14-week post-treatment follow-up Systolic and Diastolic Blood Pressure In-lab measurement with OMRON 10 Series Wireless Upper Arm Blood Pressure Monitor
Grip Strength baseline, immediate post-treatment, 14-week post-treatment follow-up In-lab measurement with Jamar Plus+ Digital Hand Dynamometer
Perceived General Health baseline, immediate post-treatment, 14-week post-treatment follow-up Medical Outcomes Study (MOS) Short Form Health Survey (SF-36), General Health Perceptions Subscale, 1-5, higher scores better
Momentary Mood 3x daily; weeks 1-8, 19, 20 Rate your current mood. 1 (very bad) to 7 (very good), higher scores better
Peak Expiratory Flow Rate baseline, immediate post-treatment, 14-week post-treatment follow-up In-lab measurement with EasyOne Air Spirometer
- Secondary Outcome Measures
Name Time Method Joy baseline, immediate post-treatment, 14-week post-treatment follow-up Dispositional Positive Emotions Scale, 1-7, higher scores better
Awe baseline, immediate post-treatment, 14-week post-treatment follow-up Dispositional Positive Emotions Scale, 1-7, higher scores better
Contentment baseline, immediate post-treatment, 14-week post-treatment follow-up Dispositional Positive Emotions Scale, 1-7, higher scores better
Compassion baseline, immediate post-treatment, 14-week post-treatment follow-up Dispositional Positive Emotions Scale, 1-7, higher scores better
Pride baseline, immediate post-treatment, 14-week post-treatment follow-up Dispositional Positive Emotions Scale, 1-7, higher scores better
Love baseline, immediate post-treatment, 14-week post-treatment follow-up Dispositional Positive Emotions Scale, 1-7, higher scores better
Sleep Quality 1x daily; weeks 1-8, 19, 20 How would you rate the quality of your sleep last night? 1 (very bad) to 4 (very good), higher scores better
Tobacco Use (non-cigarette products) baseline, immediate post-treatment, 14-week post-treatment follow-up tobacco use days/month x average uses per day of using, lower scores better
Alcohol Use baseline, immediate post-treatment, 14-week post-treatment follow-up days in last month drinking x average number of drinks/drinking day, lower scores better
Role Functioning--Emotional baseline, immediate post-treatment, 14-week post-treatment follow-up MOS Short Form Health Survey (SF-36), Emotional Role Functioning Subscale, 0-3, lower scores better
Vitality baseline, immediate post-treatment, 14-week post-treatment follow-up MOS Short Form Health Survey (SF-36), Vitality Subscale, 1-6, higher scores better
Momentary physical activity 3x daily; weeks 1-8, 19, 20 Physical activity behaviors checklist, 0-3, higher scores better
Amusement baseline, immediate post-treatment, 14-week post-treatment follow-up Dispositional Positive Emotions Scale, 1-7, higher scores better
Depression baseline, immediate post-treatment, 14-week post-treatment follow-up Patient Health Questionnaire-9, 0-27, lower scores better
Anxiety baseline, immediate post-treatment, 14-week post-treatment follow-up State-Trait Anxiety Inventory, 1-4, lower scores better
Social Connectedness baseline, immediate post-treatment, 14-week post-treatment follow-up Comprehensive Inventory of Thriving, 1-5, higher scores better
Social Support baseline, immediate post-treatment, 14-week post-treatment follow-up Perceived Social Support Scale, 1-5, higher scores better
Walking baseline, immediate post-treatment, 14-week post-treatment follow-up International Physical Activity Questionnaire, days/week x minutes/day, higher scores better
Momentary tobacco use 3x daily; weeks 1-8, 19, 20 Have you used a tobacco product in the previous 4 hours? 0 (no)/1(yes), lower scores better
Momentary eating 3x daily; weeks 1-8, 19, 20 Have you eaten \[fruit or vegetable/sugary dessert, snack, or beverage\] in the previous 4 hours? 0-2, higher scores better
Hope baseline, immediate post-treatment, 14-week post-treatment follow-up State Hope Scale, 1-8, higher scores better
Loneliness baseline, immediate post-treatment, 14-week post-treatment follow-up UCLA Loneliness Scale, 1-4, lower scores better
Cigarette Use baseline, immediate post-treatment, 14-week post-treatment follow-up cigarette smoking days/month x cigarettes per average smoking day, lower scores better
Moderate Activity Level baseline, immediate post-treatment, 14-week post-treatment follow-up International Physical Activity Questionnaire, days/week x minutes/day, higher scores better
Physical Functioning baseline, immediate post-treatment, 14-week post-treatment follow-up MOS Short Form Health Survey (SF-36), Physical Functioning Subscale, 1-3, higher scores better
Social Functioning baseline, immediate post-treatment, 14-week post-treatment follow-up MOS Short Form Health Survey (SF-36), Social Functioning Subscale, 0-5, lower scores better
Momentary connective Behaviors 3x daily; weeks 1-8, 19, 20 Connective behaviors checklist, 0-5, higher scores better
Momentary Perceived General Health 3x daily; weeks 1-8, 19, 20 How do you feel in terms of your physical health right now? 1 (poor) to 5 (excellent), higher scores better
Sleep Duration 1x daily; weeks 1-8, 19, 20 Wake up time - (lights out time + time to fall asleep), higher scores better
Momentary Loneliness 3x daily; weeks 1-8, 19, 20 How lonely do you feel right now? 1(not at all) to 7 (very much), lower scores better
Perceived Stress baseline, immediate post-treatment, 14-week post-treatment follow-up Perceived Stress Scale, 0-4, lower scores better
Vigorous Activity Level baseline, immediate post-treatment, 14-week post-treatment follow-up International Physical Activity Questionnaire, days/week x minutes/day, higher scores better
Role Functioning--Physical baseline, immediate post-treatment, 14-week post-treatment follow-up MOS Short Form Health Survey (SF-36), Physical Role Functioning Subscale, 0-4, lower scores better
Bodily Pain baseline, immediate post-treatment, 14-week post-treatment follow-up MOS Short Form Health Survey (SF-36), Pain Subscale, 2-11, lower scores better
Momentary alcohol use 3x daily; weeks 1-8, 19, 20 Have you consumed alcohol in the previous 4 hours? 0 (no)/1(yes), lower scores better
Sitting baseline, immediate post-treatment, 14-week post-treatment follow-up International Physical Activity Questionnaire, hours/weekday, lower scores better
General Mental Health baseline, immediate post-treatment, 14-week post-treatment follow-up MOS Short Form Health Survey (SF-36), General Mental Health Subscale, 1-6, higher scores better
Momentary Depression 3x daily; weeks 1-8, 19, 20 How depressed do you feel right now? 1(not at all) to 7 (very much), lower scores better
Common Symptoms Checklist 1x daily; weeks 1-8, 19, 20 1-5, lower scores better
Momentary Stress 3x daily; weeks 1-8, 19, 20 How stressed do you feel right now? 1(not at all) to 7 (very much), lower scores better
Momentary Anxiety 3x daily; weeks 1-8, 19, 20 How anxious do you feel right now? 1(not at all) to 7 (very much), lower scores better