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临床试验/NCT04287374
NCT04287374已完成不适用

The Effects of Online Single-Session Interventions on College Student Well-being

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 294 人开始时间: 2020年3月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
294
试验地点
2
主要终点
Change in Patient Health Questionnaire-9 (PHQ-9)

研究概览

简要总结

This study seeks to investigate the effects of an online single-session intervention on college student mental health and well-being. Undergraduate students from the University of Pennsylvania and Harvard will be randomized to a 30-minute single-session intervention or a study skills control group. Students' depressive symptoms, anxiety symptoms, positive and negative affect, and subjective well-being will be assessed up to 12 weeks post-intervention.

详细描述

The design of our study is a randomized control trial. After enrollment in the study, participants will randomly assigned to one of two conditions. In each condition, participants will be asked to complete an initial survey of mental health and well-being measures. Following this survey, participants will complete either a well-being skills single-session intervention or control single-session intervention (study skills) depending on which condition they were assigned to. These single-session interventions educate the participant on their focal concept and teach them exercises to improve that skill. Completing the single-session intervention will take approximately 20-30 minutes.

After completing their single-session intervention, all participants will retake the measures of mental health and well-being presented to them at the beginning of the program. Participants will also be asked to complete measures of intervention feasibility, acceptability and appropriateness at this time.

Following this initial intervention, participants will retake the measures of well-being and mental health at 2 weeks, 4 weeks, and 12 weeks after they completed the intervention. This will allow us to fulfill our first objective by determining how long single-session interventions improve undergraduate mental health and well-being.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 22 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Current undergraduate student at select universities
  • •Able to access the internet
  • •Can participate in follow-up surveys for three months post sign-up

排除标准

  • •Unable to access the internet
  • •Will not be able to respond to the follow-up surveys post-intervention

研究组 & 干预措施

Multi-component Well-being Intervention

Experimental

Reading and writing activities based on cognitive restructuring (rephrasing automatic negative thoughts), gratitude (noticing and appreciating good things in life), and behavioral activation (identifying and scheduling positive activities)

干预措施: Multi-component Well-being Intervention (Behavioral)

Study Skills Control

Sham Comparator

Reading and writing activities designed to teach evidence-based study strategies.

干预措施: Study Skills (Behavioral)

结局指标

主要结局

Change in Patient Health Questionnaire-9 (PHQ-9)

时间窗: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up

Depression Questionnaire. The total score ranges from 0 to 27. Lower scores indicate a better outcome.

Change in Generalized Anxiety Disorder Screener-7 (GAD-7)

时间窗: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up

Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome.

Change in The Warwick-Edinburgh Mental Wellbeing Scale

时间窗: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up

Well-being questionnaire. Total score ranges from 14 to 70. Higher values indicate a better outcome.

次要结局

  • Change in Perceived Stress Scale-4(Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up)
  • Acceptability of Intervention Measure(Immediately post-intervention (0 weeks))
  • Feasibility of Intervention Measure(Immediately post-intervention (0 weeks))
  • Intervention Appropriateness Measure(Immediately post-intervention (0 weeks))
  • Change in Gratitude Questionnaire-6(Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up)
  • Change in Beck Hopelessness Scale (4-item version)(Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up)
  • Change in Positive and Negative Affect Schedule(Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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