Behavioral Mechanisms and Health Outcomes of Positive Psychological Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 主要终点
- Meaning in Life
研究概览
简要总结
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:
- Test the efficacy of a multi-activity positive psychology intervention for increasing emotional well-being in a racial-ethnically and socioeconomically diverse sample.
- Identify physical and social behavioral mechanisms driving positive psychology intervention effects on emotional well-being change and the durability of these effects over time.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fluent or native English speaker capable of completing survey questionnaires in English
排除标准
- •Major depressive disorder (PHQ-9 > or = 15)
结局指标
主要结局
Meaning in Life
时间窗: baseline, immediate post-treatment, 14-week post-treatment follow-up
Meaning in Life Questionnaire, 1-7 scale, higher scores better
Negative Affect
时间窗: baseline, immediate post-treatment, 14-week post-treatment follow-up
Scale of Positive and Negative Affect, 1-5 scale, lower scores better
Positive Affect
时间窗: baseline, immediate post-treatment, 14-week post-treatment follow-up
Scale of Positive and Negative Affect, 1-5 scale, higher scores better
Optimism
时间窗: baseline, immediate post-treatment, 14-week post-treatment follow-up
Life Orientation Test-Revised, 1-5 scale, higher scores better
Heart Rate
时间窗: 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
时间窗: 3x daily; weeks 1-8, 19, 20
Daily Meaning Scale, 1-7, higher scores better
Life Satisfaction
时间窗: baseline, immediate post-treatment, 14-week post-treatment follow-up
Satisfaction with Life Scale, 1-7 scale, higher scores better
Blood Pressure
时间窗: 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
时间窗: baseline, immediate post-treatment, 14-week post-treatment follow-up
In-lab measurement with Jamar Plus+ Digital Hand Dynamometer
Perceived General Health
时间窗: 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
时间窗: 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
时间窗: baseline, immediate post-treatment, 14-week post-treatment follow-up
In-lab measurement with EasyOne Air Spirometer
次要结局
- Joy(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Awe(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Contentment(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Compassion(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Pride(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Vitality(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Love(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Sleep Quality(1x daily; weeks 1-8, 19, 20)
- Tobacco Use (non-cigarette products)(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Alcohol Use(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Role Functioning--Emotional(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Momentary physical activity(3x daily; weeks 1-8, 19, 20)
- Amusement(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Depression(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Anxiety(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Social Connectedness(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Social Support(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Walking(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Momentary tobacco use(3x daily; weeks 1-8, 19, 20)
- Momentary eating(3x daily; weeks 1-8, 19, 20)
- Hope(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Loneliness(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Cigarette Use(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Moderate Activity Level(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Physical Functioning(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Social Functioning(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Momentary connective Behaviors(3x daily; weeks 1-8, 19, 20)
- Momentary Perceived General Health(3x daily; weeks 1-8, 19, 20)
- Sleep Duration(1x daily; weeks 1-8, 19, 20)
- Momentary Depression(3x daily; weeks 1-8, 19, 20)
- Perceived Stress(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Vigorous Activity Level(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Role Functioning--Physical(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Bodily Pain(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Momentary alcohol use(3x daily; weeks 1-8, 19, 20)
- Common Symptoms Checklist(1x daily; weeks 1-8, 19, 20)
- Sitting(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- General Mental Health(baseline, immediate post-treatment, 14-week post-treatment follow-up)
- Momentary Stress(3x daily; weeks 1-8, 19, 20)
- Momentary Anxiety(3x daily; weeks 1-8, 19, 20)
- Momentary Loneliness(3x daily; weeks 1-8, 19, 20)
研究者
Samantha J. Heintzelman, PhD
Assistant Professor
Rutgers, The State University of New Jersey