Clinical trial NCT06483568: Behavioral Mechanisms and Health Outcomes of Positive Psychological Intervention
Official title: Behavioral Mechanisms and Health Outcomes of Positive Psychological Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Well-Being, Psychological
Keywords: Emotional Well-Being
Happiness
Gratitude
Kindness
Self-Compassion
Capitalization
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to complete positive psychology intervention activities or procedure-matched activities related to personal organization.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Life Satisfaction
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Positive Affect
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Negative Affect
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Meaning in Life
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Optimism
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Perceived General Health
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Blood Pressure
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Heart Rate
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Peak Expiratory Flow Rate
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Grip Strength
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Momentary Mood
timeFrame: 3x daily; weeks 1-8, 19, 20
measure: Momentary Meaning in Life
timeFrame: 3x daily; weeks 1-8, 19, 20
Secondary outcomes:
measure: Amusement
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Awe
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Compassion
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Contentment
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Joy
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Love
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Pride
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Hope
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Depression
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Anxiety
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Perceived Stress
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Loneliness
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Social Connectedness
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Social Support
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Sleep Quality
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Cigarette Use
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Tobacco Use (non-cigarette products)
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Alcohol Use
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Vigorous Activity Level
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Moderate Activity Level
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Walking
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Physical Functioning
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Role Functioning--Physical
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Role Functioning--Emotional
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Social Functioning
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Sitting
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Bodily Pain
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: General Mental Health
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Vitality
timeFrame: baseline, immediate post-treatment, 14-week post-treatment follow-up
measure: Momentary physical activity
timeFrame: 3x daily; weeks 1-8, 19, 20
measure: Momentary tobacco use
timeFrame: 3x daily; weeks 1-8, 19, 20
measure: Momentary alcohol use
timeFrame: 3x daily; weeks 1-8, 19, 20
measure: Momentary eating
timeFrame: 3x daily; weeks 1-8, 19, 20
measure: Momentary connective Behaviors
timeFrame: 3x daily; weeks 1-8, 19, 20
measure: Momentary Stress
timeFrame: 3x daily; weeks 1-8, 19, 20
measure: Momentary Depression
timeFrame: 3x daily; weeks 1-8, 19, 20
measure: Momentary Anxiety
timeFrame: 3x daily; weeks 1-8, 19, 20
measure: Momentary Loneliness
timeFrame: 3x daily; weeks 1-8, 19, 20
measure: Momentary Perceived General Health
timeFrame: 3x daily; weeks 1-8, 19, 20
measure: Sleep Quality
timeFrame: 1x daily; weeks 1-8, 19, 20
measure: Sleep Duration
timeFrame: 1x daily; weeks 1-8, 19, 20
measure: Common Symptoms Checklist
timeFrame: 1x daily; weeks 1-8, 19, 20
Other outcomes:
Locations:
Study officials:
References: