Comparing Two Ways to Mitigate the Impact of the COVID-19 Pandemic on Mental Health Among Adults From Underserved and Racial Minority Communities
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Changes in Worry from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
研究概览
简要总结
The purpose of this study is to examine the comparative effectiveness of two technology-based Mindfulness Based Stress Reduction (MBSR) programs (one via video/teleconference and one via a smartphone app) for reducing worry, anxiety and/or related mental health effects of stress in members of identified underserved communities, which were highly impacted by the COVID-19 pandemic.
详细描述
The purpose of this randomized controlled study is to examine the comparative effectiveness of two technology-based Mindfulness Based Stress Reduction (MBSR) programs (one via video/teleconference and one via a smartphone app) for reducing worry, anxiety, and/or related mental health effects of stress in members of identified underserved communities, which were highly impacted by the COVID-19 pandemic. Participants will be randomly assigned to a teleconference MBSR program, a MBSR smartphone app program, or a waitlist control group. Each intervention includes participation in a 9-week (8 sessions plus an introduction) mindfulness intervention that consists of instruction and daily practice. Questionnaires and semi-structured interviews will be administered at mid-intervention, post-intervention, and one-month and three-month follow-up points. It is hypothesized that participants in the two intervention groups will show measurable and sustained improvement in the primary outcome, worry, as well as in the secondary outcomes, anxiety and related mental health effects. It is further hypothesized that the smartphone app mindfulness intervention will show similar effectiveness to the teleconference mindfulness intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •18 years and older
- •Significant worry as per the Penn State Worry Questionnaire-Abbreviated [PSWQ-A]
- •Fluent in English
- •Reside in one of the local city zip codes, identified as underserved, and primarily African American, communities
排除标准
- •Severe depression as per Patient Health Questionnaire [PHQ-9]
- •Active suicidal intent as per PHQ-9 question 9
- •Diagnosis of psychosis, or bipolar disorder, or moderate or severe substance use disorder in the past month as per self report
- •Cognitive impairment as per (modified) Short Portable Mental Status Questionnaire [SPMSQ]
- •Currently receiving psychotherapy or behavioral counseling, including MBSR
- •Change in psychotropic medications within the last month as per self report
- •Unable to communicate in a way that would allow for participation in screenings or sessions
结局指标
主要结局
Changes in Worry from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
时间窗: 21 Weeks: Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
A total score on the Penn State Worry Questionnaire \[PSWQ\], a scaled measure with total scores ranging from 16 to 80, in which higher scores indicate greater severity of worry
次要结局
- Changes in Depression from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention(Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention)
- Changes in Sleep Quality from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention(21 weeks Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention)
- Changes in Psychological Well-being from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention(21 Weeks Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention)
- Changes in Loneliness from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention(21 Weeks Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention)
- Changes in Social Disconnectedness from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention(21 Weeks Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention)
- Quality of life, satisfaction with(21 Weeks Change from Baseline score to score at mid-intervention, end of intervention, and follow-up scores at one month and three months past end of intervention)
- Changes in Anxiety from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention(21 Weeks: Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention)
- Changes in Perceived Stress from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention(21 Weeks: Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention)
- Changes in Mindfulness from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention(21 weeks Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention)
研究者
Yu-Ping Chang
Principal Investigator, Professor and Associate Dean for Research and Scholarship
State University of New York at Buffalo