A Randomized Controlled Trial of an Online Well-Being Intervention (The ENHANCE Program) for Improving Individuals Health and Well-Being During the COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Perceived Stress Scale (PSS)
研究概览
简要总结
This study is a randomized controlled trial of an online, evidenced-based intervention (the ENHANCE program) that was modified to address the health and well-being challenges of COVID-19. Eligible participants will be randomized into the ENHANCE or Wait-List Control group over a 12-week period. ENHANCE participants will be introduced, and asked to practice, 10 evidenced-based principles and skills of happiness and well-being. Participants will complete an online survey about their health and well-being at baseline, midway (or 6 weeks), post-assessment (or at the end of the 12-week study), and 3-months following the end of the study.
详细描述
The study is designed as a 12-week, two-armed, randomized controlled trail to assess the efficacy of a COVID-19-modified version of the Enduring Happiness and Continued Self-Enhancement (ENHANCE) program. The ENHANCE program represents a 12-week multi-construct, evidenced-based intervention for improving overall happiness and subjective well-being. The ENHANCE program was modified specifically to address the known health and well-being challenges of the COVID-19 pandemic.
Eligible participants will be randomized into either the ENHANCE program or Wait-List Control (WLC) group. ENHANCE participants will be introduced to 10 evidenced-based principles that have been shown to improve health and well-being outcomes. Participants will be further guided to systematically practice these principles in their daily lives using a small-changes approach. WLC participants will be asked to continue life a usual, and provided some additional health and well-being resources that can be accessed online to support current, ongoing distress, if needed.
Participants will be asked to complete an online survey about their emotional, social, and physical well-being at baseline (or at the start of the study), midway (or 6-weeks into the study), and at post-assessment (or at the end of the study period). At the end of the study period, all control participants will also be offered the full ENHANCE program.
Investigators expect that participants receiving the ENHANCE program will show improvements across all negative (e.g., depression, anxiety) and positive (e.g., life satisfaction, quality of life) variables from baseline to post-study. Investigators further expect there to be immediate positive health and economic outcomes linked to active participation in the ENHANCE program (versus the WLC group). Investigators believe the impacts of this research will include (a) mitigating the risk of a severe onset of mental health problems related to anxiety, depression, post-traumatic stress, and suicide, (b) increasing positive mental health and well-being, and (c) increasing physical health in participants across time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who are fluent in English and are 19 years or older.
排除标准
- 未提供
结局指标
主要结局
Perceived Stress Scale (PSS)
时间窗: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Change from baseline stress
Generalized Anxiety Disorder - 7 (GAD-7)
时间窗: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Change from baseline anxiety
Beck Depression Inventory - II (BDI-II)
时间窗: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Change from baseline mood
Patient Health Questionnaire (PHQ-9)
时间窗: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Change from baseline mood
Positive and Negative Affect Scale (PANAS)
时间窗: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Change from baseline affect
Health Anxiety Inventory Short-Form (HAI-SF)
时间窗: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Change from baseline anxiety
Satisfaction With Life Scale (SWLS)
时间窗: Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months)
Change from baseline satisfaction with life
次要结局
- Sleep Disorder Questionnaire (SDQ)(Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months))
- PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5)(Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months))
- Meaning In Life Questionnaire (MLQ)(Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months))
- Paffenbarger Physical Activity Questionnaire (PPAQ)(Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months))
- University of California, Los Angeles Loneliness Scale (UCLA Loneliness Scale)(Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months))
- European Quality of Life Group - 5 Dimensions - 5 Levels (EQ-5D-5L)(Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months))
- World Health Organization Quality of Life (WHOQOL - BREF)(Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months))
- Measure of Attachment Qualities (MAQ)(Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months))
- Insomnia Severity Index (ISI)(Baseline, Mid-assessment (6 weeks), Post-assessment (3 months), Follow-up-assessment (6 months))
研究者
Lesley Lutes
Dr. Lesley Lutes, R.Psych.
University of British Columbia