跳至主要内容
临床试验/NCT04367922
NCT04367922已完成不适用

A Positive Affect Regulation sKills Intervention to Decrease Stress During a Pandemic: A Single Arm, Non-Randomized Trial of a Public Platform

Northwestern University2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年4月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
2
主要终点
Change in anxiety

研究概览

简要总结

The Positive Affect Regulation sKills (PARK) Course is an online program containing a series of positive emotion skills for individuals experiencing stress and distress as a result of COVID-19 and the return to "normal." The study specifically targets positive emotion, and offers an array of skills in a self-guided online delivery platform, making the program accessible and convenient in confusing and stressful times.

Our main aims are:

Aim 1: To explore the effects of PARK on anxiety, depression, feelings of social isolation, positive affect, and a sense of meaning and purpose.

Aim 2: To test whether age or gender moderate the effects of the program.

详细描述

The goal of the proposed program, PARK, is to reduce feelings of anxiety, depression, and social isolation, as well as increase well-being and a sense of meaning and purpose through the practice of positive emotion skills via a self-guided online platform. We will compare baseline scores on PROMIS measures of Anxiety, Depression, Social Isolation, Meaning and Purpose, and Positive Emotion to scores after completing the online course (approximately 8 weeks later), and again at 6 months post-baseline.

Research will be based in Northwestern's Feinberg School of Medicine through the Department of Medical Social Sciences (MSS), with all study procedures conducted online. Eligibility screening, consent, and assessments will be conducted on REDCap. For the positive skills course (including weekly lessons and daily skills practice) and daily emotion check-ins, consenting participants will receive access to the online PARK platform, hosted by BrightOutcome.

The skills will be delivered over approximately 6 weeks, and individuals can participate from any device and location with internet access.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 18 years of age
  • Speaks and reads English
  • Able to access the online platform through their phone, a public device (i.e., at the library) or at home.
  • Lives in US

排除标准

  • Inability to communicate in English
  • Lives outside the US
  • Under 18 years of age

结局指标

主要结局

Change in anxiety

时间窗: Baseline, 6 weeks, 6 months

Assessed using PROMIS Anxiety (CAT)

Change in depression

时间窗: Baseline, 6 weeks, 6 months

Assessed using PROMIS Depression (CAT)

Change in positive affect

时间窗: Baseline, 6 weeks, 6 months

Assessed using PROMIS Positive Affect (CAT)

Change in feelings of social isolation

时间窗: Baseline, 6 weeks, 6 months

Assessed using PROMIS Social Isolation (CAT)

Change in sense of meaning and purpose

时间窗: Baseline, 6 weeks, 6 months

Assessed using PROMIS Meaning and Purpose (CAT)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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