An Integrated Online Intervention Addressing Mental Health and Substance Use in University Students: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,489
- 试验地点
- 2
- 主要终点
- Change in Depressive symptomology from Baseline to Follow-up at 30 days
研究概览
简要总结
The purpose of this study is to assess the effectiveness of mobile app containing a range of evidence based tools to improve the mental health and substance use outcomes of university students.
详细描述
There is a need for scalable interventions to support the mental health and substance use challenges experienced by university students. One means of addressing this need is through the use of e-mental health tools that facilitate self-management and connect students to in-person supports as needed. This is a randomized controlled trial of a mobile app designed to help university students manage their mental health and substance use via a set of evidence-based tools that have been integrated into a single mobile app. The recruitment of approximately 1500 students will occur through social media, promotion by faculty members and administrators, and other in-person recruitment methods. Assessments will be conducted using self-report web surveys at baseline, 14 days (interim assessment) and 30 days (follow-up assessment). The goal of the trial is to assess the effectiveness of the app in improving a range of mental health and substance use outcomes of university students from baseline to follow-up.
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 (Investigator)
盲法说明
Single blinded in that only the investigators (including the statistician) will be blinded to the treatment group assignment when examining the primary hypotheses.
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be currently enrolled at participating university
- •Must be 17 years or older
- •Must have access to and be able to use a smart phone with Wi-Fi and/or mobile data
- •Must be English speaking
排除标准
- •Any participants that self-identify as currently having a suicidal plan at the time of study enrollment
结局指标
主要结局
Change in Depressive symptomology from Baseline to Follow-up at 30 days
时间窗: The PHQ-9 will be administered to both the intervention and control group at baseline and 30 days.
Assessed by the Patient Health Questionnaire 9-item (PHQ-9) scale. Changes in depressive symptomology from baseline to follow-up at 30 days will be based on total scores on the PHQ-9 in both the intervention and control groups. Total scores range from 0 to 29 with higher scores indicating a worse outcome (i.e., a greater frequency of depression symptoms).
Change in General anxiety symptomology from Baseline to Follow-up at 30 days
时间窗: The GAD-7 will be administered to both the intervention and control groups at baseline and 30 days.
Assessed by the General Anxiety Disorder 7-Item (GAD-7) scale. Changes in anxiety symptomology from baseline to follow-up at 30 days will be based on total scores on the GAD-7 in both the intervention and control groups. Total scores range from 0 to 21 with higher scores indicating a worse outcome (i.e, a greater frequency of anxiety symptoms).
Change in Alcohol consumption risk from Baseline to Follow-up at 30 days
时间窗: The USAUDIT-C will be administered to the intervention and control groups at baseline and 30 days.
Assessed by the alcohol consumption questions of the Alcohol Use Disorders Identification Test, Adapted for Use in the United States (USAUDIT-C). Changes in alcohol consumption risk from baseline to follow-up at 30 days will be based on total scores on the USAUDIT-C in both the intervention and control groups. Total scores range from 0 to 18 with higher scores indicating a worse outcome (i.e., a higher level of risky drinking).
次要结局
- Frequency of binge drinking(Frequency of binge drinking will be assessed in the intervention and control groups at baseline and at 30 days.)
- Frequency of alcohol use(Frequency of alcohol use will be assessed in the intervention and control groups at baseline and at 30 days.)
- Frequency of cannabis consumption(Frequency of cannabis consumption will be assessed in the intervention and control groups at baseline and at 30 days.)
- Readiness to change(Readiness to change will be assessed in the intervention and control groups at baseline and at 30 days.)
- Self-efficacy related to the management of substance use.(Substance use self-efficacy will be assessed in the intervention and control groups at baseline and at 30 days.)
- Self-efficacy related to the management of mental health.(Mental health self-efficacy will be assessed in the intervention and control groups at baseline and at 30 days.)
- Frequency of non-medical stimulant use(Frequency of non-medical stimulant use will be assessed in the intervention and control groups at baseline and at 30 days.)
- Frequency of opioid use(Frequency of opioid use will be assessed in the intervention and control groups at baseline and at 30 days.)
- Mental Well-being(The Short Warwick-Edinburgh Mental Wellbeing Scale will be administered in the intervention and control groups at baseline and at 30 days.)
- Self-reported use of mental health services and supports(Use of mental health services and supports will be assessed in the intervention and control groups at baseline and at 30 days.)
研究者
Daniel Vigo
Assistant Professor
University of British Columbia