Effectiveness and Acceptability of Internet-delivered Treatment for Depression, Anxiety and Stress in University Students: Protocol for an Open Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in Stress sub-scale of Depression Anxiety and Stress Scale-21 (DASS-21)
研究概览
简要总结
The aims of this study are to test the effectiveness and acceptability of internet-delivered treatment for depression, anxiety and stress in university students. These data will inform the methods for a future randomized controlled trial.
The trial will establish an initial estimate of the effectiveness of these online interventions for students in terms of within-group effect sizes associated with changes in depression, anxiety and stress from pre to post-intervention and follow-up. These data will be used to estimate the sample size for a future trial to ensure that the study is sufficiently powered. A conservative estimate using the 90% upper confidence limit will be used to inform the sample size calculation of the definitive RCT.
Acceptability of the intervention to participants will be assessed using data on usage and engagement with the intervention (e.g. percentage of participants completing each module, average number of log ins, average time spent per session and total time spent on the program). These data are acquired through the online SilverCloud system. Satisfaction with will be assessed through the use of a post-intervention questionnaire on satisfaction with accessing and using an online delivery format for treatment.
详细描述
Depression, anxiety and stress are among the primary causes of disease rates worldwide and are the most prevalent mental health problems in the U.S. Each is associated with significant economic, personal, intrapersonal and societal losses including lower quality of life and increased mortality.
Depression, Anxiety and Stress in Students:
Depression and anxiety are also the most prevalent mental health problems among the student population. In the 2010 American College Health Survey, 48% of college and university students reported feeling overwhelming anxiety at least once in the previous year. Thirty-one percent reported feeling so depressed it was difficult to function at least once in the previous 12 months. More recently, University counseling and mental health services have reported an increase in the number of clients seeking services and in yearly visits.
The college years can be a highly stressful time in students' lives. This is particularly true of the period of transition to college as students are learning to cope with increased academic pressures. Students are at a developmental stage when newfound stressors can promote the onset of mental health difficulties. In addition to academic stress, international students can experience significant sociocultural adjustment demands.
Young adults between 17 and 25 years of age are reported to be at greater risk of developing a serious mental illness than individuals in other age groups. Although early diagnosis of mental disorders can be difficult, delayed diagnosis can often lead to treatment resistance and poorer longer-term outcomes. In addition, underachievement or failure at this point in life can cause long-term setbacks to individuals' self-esteem and future progress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Participants must be at least 18 years of age. Participants must have self-reported mild to severe symptoms of depression (5-27+) according to PHQ-9, self-reported mild to severe symptoms of anxiety (5-21+) according to GAD-7, or self-reported mild to severe symptoms of stress (15-34+) according to the stress sub-scale of DASS-21.
排除标准
- •Students who currently are in face-to-face therapy at UCCS or BHS will be excluded. Students who score in the "red zone" in terms of risk of self-harm on the screening questions routinely used at UCCS will not be referred to the study. Students who score greater than 0 on the PHQ-9 self-harm item during the initial screening phase will be automatically directed to be further evaluated and alerted that a counselor will try to reach them. Based on this further evaluation, they may be recommended to seek help from their health/counseling service and may/may not be eligible to participate in the study. They will be telephoned within 1 working day and contacted by email if they cannot be reached by phone.
研究组 & 干预措施
Depression Condition
Participants in this group will be offered the Space from Depression programme to be completed over an 8 week period. The programme is delivered through the online SilverCloud platform.
干预措施: Space from Depression (Other)
Anxiety Condition
Participants in this group will be offered the Space from Anxiety programme to be completed over an 8 week period. The programme is delivered through the online SilverCloud platform.
干预措施: Space from Anxiety (Other)
Stress Condition
Participants in this group will be offered the Space from Stress programme to be completed over an 8 week period. The programme is delivered through the online SilverCloud platform.
干预措施: Space from Stress (Other)
结局指标
主要结局
Change in Stress sub-scale of Depression Anxiety and Stress Scale-21 (DASS-21)
时间窗: Baseline, postintervention at 8 weeks and 3 month follow-up
Composed of 7-item sub-scale measuring symptoms of stress.
Change in Patient Health Questionnaire-9 (PHQ-9)
时间窗: Baseline, postintervention at 8 weeks and 3 month follow-up
A self-report measure of depression that has been widely used in screening, primary care, and research.
Change in Generalized Anxiety Disorder-7 (GAD-7)
时间窗: Baseline, postintervention at 8 weeks and 3 month follow-up
Comprises 7 items measuring symptoms and severity of GAD based on the DSM-IV diagnostic criteria for GAD.
次要结局
未报告次要终点
