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Behavioral Mechanisms and Health Outcomes of Positive Psychological Intervention

Behavioral Mechanisms and Health Outcomes of Positive Psychological Intervention

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06483568
Enrollment
250
Registered
2024-07-03
Start date
2024-07-15
Completion date
2025-07-01
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Well-Being, Psychological

Keywords

Emotional Well-Being, Happiness, Gratitude, Kindness, Self-Compassion, Capitalization

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.

Interventions

BEHAVIORALPathways to Happiness Intervention

Four weeks of activities including a gratitude journal, random acts of kindness, self-compassionate letter, and capitalizing on positive events activities.

BEHAVIORALPersonal Organization Activities

Four weeks of activities including a completed tasks journal, weekly task burst, productivity letter, and talking to others about task activities.

Sponsors

Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Masking description

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.

Intervention model description

Participants will be randomly assigned to complete positive psychology intervention activities or procedure-matched activities related to personal organization.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Fluent or native English speaker capable of completing survey questionnaires in English

Exclusion criteria

* Major depressive disorder (PHQ-9 \> or = 15)

Design outcomes

Primary

MeasureTime frameDescription
Life Satisfactionbaseline, immediate post-treatment, 14-week post-treatment follow-upSatisfaction with Life Scale, 1-7 scale, higher scores better
Positive Affectbaseline, immediate post-treatment, 14-week post-treatment follow-upScale of Positive and Negative Affect, 1-5 scale, higher scores better
Negative Affectbaseline, immediate post-treatment, 14-week post-treatment follow-upScale of Positive and Negative Affect, 1-5 scale, lower scores better
Meaning in Lifebaseline, immediate post-treatment, 14-week post-treatment follow-upMeaning in Life Questionnaire, 1-7 scale, higher scores better
Optimismbaseline, immediate post-treatment, 14-week post-treatment follow-upLife Orientation Test-Revised, 1-5 scale, higher scores better
Perceived General Healthbaseline, immediate post-treatment, 14-week post-treatment follow-upMedical Outcomes Study (MOS) Short Form Health Survey (SF-36), General Health Perceptions Subscale, 1-5, higher scores better
Blood Pressurebaseline, immediate post-treatment, 14-week post-treatment follow-upSystolic and Diastolic Blood Pressure In-lab measurement with OMRON 10 Series Wireless Upper Arm Blood Pressure Monitor
Heart Ratebaseline, immediate post-treatment, 14-week post-treatment follow-upIn-lab measurement with OMRON 10 Series Wireless Upper Arm Blood Pressure Monitor
Peak Expiratory Flow Ratebaseline, immediate post-treatment, 14-week post-treatment follow-upIn-lab measurement with EasyOne Air Spirometer
Grip Strengthbaseline, immediate post-treatment, 14-week post-treatment follow-upIn-lab measurement with Jamar Plus+ Digital Hand Dynamometer
Momentary Mood3x daily; weeks 1-8, 19, 20Rate your current mood. 1 (very bad) to 7 (very good), higher scores better
Momentary Meaning in Life3x daily; weeks 1-8, 19, 20Daily Meaning Scale, 1-7, higher scores better

Secondary

MeasureTime frameDescription
Social Connectednessbaseline, immediate post-treatment, 14-week post-treatment follow-upComprehensive Inventory of Thriving, 1-5, higher scores better
Social Supportbaseline, immediate post-treatment, 14-week post-treatment follow-upPerceived Social Support Scale, 1-5, higher scores better
Sleep Qualitybaseline, immediate post-treatment, 14-week post-treatment follow-upPittsburgh Sleep Quality Index, 0-21, lower scores better
Cigarette Usebaseline, immediate post-treatment, 14-week post-treatment follow-upcigarette smoking days/month x cigarettes per average smoking day, lower scores better
Tobacco Use (non-cigarette products)baseline, immediate post-treatment, 14-week post-treatment follow-uptobacco use days/month x average uses per day of using, lower scores better
Alcohol Usebaseline, immediate post-treatment, 14-week post-treatment follow-updays in last month drinking x average number of drinks/drinking day, lower scores better
Vigorous Activity Levelbaseline, immediate post-treatment, 14-week post-treatment follow-upInternational Physical Activity Questionnaire, days/week x minutes/day, higher scores better
Moderate Activity Levelbaseline, immediate post-treatment, 14-week post-treatment follow-upInternational Physical Activity Questionnaire, days/week x minutes/day, higher scores better
Walkingbaseline, immediate post-treatment, 14-week post-treatment follow-upInternational Physical Activity Questionnaire, days/week x minutes/day, higher scores better
Physical Functioningbaseline, immediate post-treatment, 14-week post-treatment follow-upMOS Short Form Health Survey (SF-36), Physical Functioning Subscale, 1-3, higher scores better
Role Functioning--Physicalbaseline, immediate post-treatment, 14-week post-treatment follow-upMOS Short Form Health Survey (SF-36), Physical Role Functioning Subscale, 0-4, lower scores better
Role Functioning--Emotionalbaseline, immediate post-treatment, 14-week post-treatment follow-upMOS Short Form Health Survey (SF-36), Emotional Role Functioning Subscale, 0-3, lower scores better
Social Functioningbaseline, immediate post-treatment, 14-week post-treatment follow-upMOS Short Form Health Survey (SF-36), Social Functioning Subscale, 0-5, lower scores better
Sittingbaseline, immediate post-treatment, 14-week post-treatment follow-upInternational Physical Activity Questionnaire, hours/weekday, lower scores better
Bodily Painbaseline, immediate post-treatment, 14-week post-treatment follow-upMOS Short Form Health Survey (SF-36), Pain Subscale, 2-11, lower scores better
General Mental Healthbaseline, immediate post-treatment, 14-week post-treatment follow-upMOS Short Form Health Survey (SF-36), General Mental Health Subscale, 1-6, higher scores better
Vitalitybaseline, immediate post-treatment, 14-week post-treatment follow-upMOS Short Form Health Survey (SF-36), Vitality Subscale, 1-6, higher scores better
Momentary physical activity3x daily; weeks 1-8, 19, 20Physical activity behaviors checklist, 0-3, higher scores better
Momentary tobacco use3x daily; weeks 1-8, 19, 20Have you used a tobacco product in the previous 4 hours? 0 (no)/1(yes), lower scores better
Momentary alcohol use3x daily; weeks 1-8, 19, 20Have you consumed alcohol in the previous 4 hours? 0 (no)/1(yes), lower scores better
Joybaseline, immediate post-treatment, 14-week post-treatment follow-upDispositional Positive Emotions Scale, 1-7, higher scores better
Momentary connective Behaviors3x daily; weeks 1-8, 19, 20Connective behaviors checklist, 0-5, higher scores better
Momentary Stress3x daily; weeks 1-8, 19, 20How stressed do you feel right now? 1(not at all) to 7 (very much), lower scores better
Momentary Depression3x daily; weeks 1-8, 19, 20How depressed do you feel right now? 1(not at all) to 7 (very much), lower scores better
Momentary Anxiety3x daily; weeks 1-8, 19, 20How anxious do you feel right now? 1(not at all) to 7 (very much), lower scores better
Momentary Loneliness3x daily; weeks 1-8, 19, 20How lonely do you feel right now? 1(not at all) to 7 (very much), lower scores better
Momentary Perceived General Health3x daily; weeks 1-8, 19, 20How do you feel in terms of your physical health right now? 1 (poor) to 5 (excellent), higher scores better
Sleep Duration1x daily; weeks 1-8, 19, 20Wake up time - (lights out time + time to fall asleep), higher scores better
Common Symptoms Checklist1x daily; weeks 1-8, 19, 201-5, lower scores better
Momentary eating3x daily; weeks 1-8, 19, 20Have you eaten \[fruit or vegetable/sugary dessert, snack, or beverage\] in the previous 4 hours? 0-2, higher scores better
Amusementbaseline, immediate post-treatment, 14-week post-treatment follow-upDispositional Positive Emotions Scale, 1-7, higher scores better
Awebaseline, immediate post-treatment, 14-week post-treatment follow-upDispositional Positive Emotions Scale, 1-7, higher scores better
Compassionbaseline, immediate post-treatment, 14-week post-treatment follow-upDispositional Positive Emotions Scale, 1-7, higher scores better
Contentmentbaseline, immediate post-treatment, 14-week post-treatment follow-upDispositional Positive Emotions Scale, 1-7, higher scores better
Lovebaseline, immediate post-treatment, 14-week post-treatment follow-upDispositional Positive Emotions Scale, 1-7, higher scores better
Pridebaseline, immediate post-treatment, 14-week post-treatment follow-upDispositional Positive Emotions Scale, 1-7, higher scores better
Hopebaseline, immediate post-treatment, 14-week post-treatment follow-upState Hope Scale, 1-8, higher scores better
Depressionbaseline, immediate post-treatment, 14-week post-treatment follow-upPatient Health Questionnaire-9, 0-27, lower scores better
Anxietybaseline, immediate post-treatment, 14-week post-treatment follow-upState-Trait Anxiety Inventory, 1-4, lower scores better
Perceived Stressbaseline, immediate post-treatment, 14-week post-treatment follow-upPerceived Stress Scale, 0-4, lower scores better
Lonelinessbaseline, immediate post-treatment, 14-week post-treatment follow-upUCLA Loneliness Scale, 1-4, lower scores better

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026