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临床试验/NCT04643964
NCT04643964已完成不适用

Building Mental Health Resilience in the COVID-19 Pandemic.

Ohio State University2 个研究点 分布在 1 个国家目标入组 655 人开始时间: 2020年11月17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
655
试验地点
2
主要终点
Change in the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR)

研究概览

简要总结

In this study, we test brief video interventions for those with elevated depressive symptoms. We randomize participants to one of three conditions. (1) An entrée condition involving in-depth coverage a set of cognitive behavioral therapy (CBT) skills. (2) A sampler condition which introduces three sets of CBT skills. (3) A control condition involving no skills. Among those in the entrée condition, participants are further randomized to one of three CBT skills. We plan on two sets of primary comparisons. First, we will compare the effects of each form of video intervention (i.e., entrée and sampler) to the control condition. Second, we will compare the entrée and sampler conditions. We will recruit participants from Amazon's Mechanical Turk program (MTurk). In the intervention conditions, participants will be asked to watch several videos and practice skills using worksheets. They will also be asked to practice skills introduced in the videos in the week following the intervention. In the control condition, participants will not watch videos. One week after the intervention, all participants will respond to a follow-up assessment.

详细描述

Access to the study will be provided via the MTurk website. Study measures and interventions will be provided via Qualtrics. To determine eligibility, participants will be asked to fill out a pre-screening measure of depressive symptoms, the Personal Health Questionnaire-9 (PHQ-9). Those who score 10 or higher will be eligible. After consenting to participate, participants will fill out baseline measures, be randomly assigned to a condition, participate in any condition related procedures, and then respond to a follow-up assessment one week later.

Each brief intervention consists of watching a series of videos. After each video, participants in the intervention conditions will be prompted to answer a series of questions to practice the skills explained in the videos. For the entrée and sampler conditions, watching all videos and filling out any worksheets that are part of the initial intervention is expected to take approximately 30 minutes.

Participants in the entrée and sampler conditions will be asked to work on a coping skills worksheet over the next seven days (estimated to involve about 10 minutes of work). Participants will receive an email seven days after participating in the brief intervention, asking them to take part in the following portion of the study. Before beginning the follow-up activity, participants in the intervention conditions will be asked to upload the coping skills worksheet they worked on. All participants will be asked to respond to follow-up assessment measures at this point.

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
None

盲法说明

Participants are told they may or may not be asked to watch videos and fill out worksheets. More detailed descriptions of the interventions being tested are not provided.

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

  • Score above 10 on the Patient Health Questionnaire-9
  • Are 18 years of age or older

排除标准

  • 未提供

结局指标

主要结局

Change in the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR)

时间窗: Baseline, 1-2 weeks after baseline

The Quick Inventory of Depressive Symptoms-Self Report is a 16-item self-report scale that measures depressive symptom severity. Scores range from 0 to 27, with higher scores indicating greater depressive symptoms.

次要结局

  • Change in the Styles of Emotion Response Questionnaire (SERQ)(Baseline, 1-2 weeks after baseline)
  • Change in the Ways of Responding Questionnaire (WOR)(Baseline, 1-2 weeks after baseline)
  • Change in the University of California, Los Angeles (UCLA) Loneliness Scale, Version 3(Baseline, 1-2 weeks after baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel R. Strunk

Professor

Ohio State University

研究点 (2)

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