Project HF-COVID: Evaluating Hyper-Brief, Online Materials During the COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change in Generalized Anxiety Disorder-7 (GAD-7) from Baseline to 2-week follow-up
研究概览
简要总结
The goal of this study is to test whether an online, self-administered SSI designed to strengthen perceived control over anxiety in the context of the COVID-19 pandemic (Contain COVID Anxiety) increases perceived control over anxiety more than a placebo, hand-washing-plan SSI (Remain COVID Free) in a weighted-probability sample of the United States (N = 500).
详细描述
Elevations in state anxiety, when moderate and temporary, serve an adaptive function in pandemic contexts, facilitating health behaviors like self-protection and social distancing. However, for some people elevated state anxiety transitions to anxiety disorders, creating undue suffering and impairment. Nearly 33% of both Wuhan residents and Chinese citizens screened positive for generalized anxiety disorder during the COVID-19 pandemic, with uncontrollable, persistent COVID-19-related worries strongly predicting presence of GAD. Similarly, large surveys indicate that levels of anxiety symptoms are rising among United States citizens.
This finding aligns with a large body of literature indicating stronger perceived control over one's own anxiety buffers against a variety of anxiety disorders. Thus, in the context of COVID-19, there is a pressing need for materials that might strengthen perceived control over anxiety, thereby reducing risk for anxiety disorder onset. Ideally, such materials would (1) in no way undermine positive health behaviors, like social distancing, and (2) have capacity for broad-scale, immediate accessibility. Internet-based interventions may particularly valuable during the pandemic stage of COVID-19 due to the need for social distancing, and they have already scaled up to address needs in China. However, drop out from internet-based interventions can be up to 83% and intervention engagement is a frequent issue. Fortunately, single-session experiences (SSEs) can improve mental health related outcomes with similar effect sizes as multi-session therapies, and pilot data from our team suggests they can increase general perceived control (within-group dz = 0.70).
The goal of this project is to test a web-based platform where people can confidentially access and provide feedback on brief activities, called 'single-session experiences' (SSEs), which are about 8 minutes in length, entirely self-administered, and computer-based (Contain COVID Anxiety and Project Remain COVID Free). Previous activities following the same best practices as these experiences have been shown to be safe to complete; predicted significant reductions in psychological distress; and are entirely self-administered. We will recruit a weighted-probability sample of the United States through Prolific's online platform, N = 500. All data collected from the SSEs will be confidential, and the only identifiable information that will be recorded is the participants' Prolific ID to facilitate compensation, which will be deleted from the data after the compensation has been paid. Those that choose to complete the activities have the option to submit their advice to their peers and have it posted anonymously to the web-based platform. This will provide people with an option for an easily accessible activity designed to promote healthy coping skills and resilience in a welcoming environment through which they can learn with others and share experiences.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This randomization of the order will occur using the randomizer within Qualtrics Survey Software, making the randomization process double-blind. To triple-blind our analysis process, the data will be downloaded from Qualtrics and the variable indicating what order the SSIs were presented in will be recoded before the primary analyses are conducted. Therefore, the primary analyses will be conducted without the knowledge of which condition is which.
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
- •Participant's age is 18 years and older
排除标准
- •Participant is younger than 18 years old
研究组 & 干预措施
Contain COVID Anxiety SSI
Participants first receive normalizing scientific information (including neuroscience findings) that help explain why increased anxiety during the COVID-19 is a typical response. They then read testimonials from three other people from the US who have applied a 3-step action plan for coping more effectively with their anxiety. The entire intervention takes approximately 8 minutes and is completely entirely within the Qualtrics survey platform.
干预措施: Contain COVID Anxiety SSI (Behavioral)
Remain COVID Free SSI
This placebo SSI was developed to mirror the structure of the Contain COVID Anxiety SSI, discuss COVID-19 related content, and do so without as many of the potential active ingredients of effective SSIs. Participants will receive scientific information about how soap kills the COVID-19 virus, but no neuroscience information related to behaviors or behavior change.
干预措施: Remain COVID Free SSI (Behavioral)
结局指标
主要结局
Change in Generalized Anxiety Disorder-7 (GAD-7) from Baseline to 2-week follow-up
时间窗: Baseline, 2-week follow-up
The GAD-7 asks participants to rate 7 statements based on how generally anxious they have felt over the past 2 weeks. Participants rate the 7 statements on a 4 point scale ranging from 0 (Not at all) to 3 (Nearly every day). Total score ranges from 0 to 21 with higher scores representing higher generalized anxiety.
Change in Anxiety Control Questionnaire (ACQ) from Baseline to Immediately Post-Intervention
时间窗: Baseline, immediately post-intervention, 2-week follow-up
ACQ is a 30-item questionnaire that measures an individual's level of agreement with a set of beliefs. Each item is scored on a scale from 0 (strongly disagree) to 5 (strongly agree) based on how much the statement is typical of the individual. The questionnaire measures domains of emotion control, threat control, and stress control, but only the emotion control scale (4 questions) will be used for the purposes of this study.
Change in Activity Social Distancing Intentions - 3 item version (SOC-D) from Baseline to immediately post-intervention
时间窗: Baseline, immediately post-intervention
As validated measures for social distancing intentions do not yet exist, the 3 questions used in this measure are derived from the standardized item bank provided by the Center for Disease Control. The three questions ask participants to rate how long they believe others would be willing to engage in social distancing behaviors regarding large events, public spaces, and private gatherings. Participants rate the 3 statements on a 4 point scale ranging from 1 (Less than a Month) to 4 (4 months or more). Total score ranges from 4 to 12, with a higher score indicating greater levels of intention to socially distance.
次要结局
- Activity Hand Washing Intentions - 3 item version (WASH-I)(Baseline, immediately post-intervention)
- COVID-19 Related Questions(Baseline)
- Self Hate Scale (SHS)(Baseline)
- Comprehension Questions(Immediately post-intervention)
- Everyday Discrimination Scale-Short version(Baseline)
- Inventory of Depression and Anxiety Symptoms (IDAS)(Baseline)
- Perceived Changes in generalized anxiety symptoms(2-week follow-up)
研究者
Jessica Schleider
Assistant Professor of Psychology
Stony Brook University
