A Randomised Controlled Trial of Online Group CBT for Symptoms of Depression and Anxiety Among University Students in South Africa
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Change from baseline scores in the mean symptoms of depression as measured by the PHQ-9 at 3-months.
研究概览
简要总结
The aim is to assess the effectiveness of online group CBT for reducing symptoms of depression and anxiety among university students. The investigators will conduct a four-arm randomised control trial comparing a 10-session online group CBT intervention to three mental health apps (namely SilverCloud guided, SilverCloud unguided, and Mood Flow).
详细描述
Email invitations and information about the study will be sent to random samples of students inviting those with symptoms of depression, anxiety, or stress to join the trial.
Students who express interest will be asked to complete an online consent form (providing more detailed information about the study and explaining potential risks and benefits of participation), following which they will complete a baseline assessment. Students who meet inclusion criteria will then be randomly allocated to one of four interventions. Follow-up assessments will be done at 3-, 6- and 12-months post intervention.
The baseline assessment will include measures of depression and anxiety, as well as factors that could potentially predict treatment responses (such as gender, age, substance use, self-harm, adverse childhood experiences, and physical health). Follow-up assessments will include measures of depression and anxiety, as well as substance use, self-harm, and treatment seeking.
The primary outcomes will be symptoms of depression and anxiety as measured by the GAD-7 and PHQ-9.
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 (Participant)
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
- •Aged 18 or older years.
- •Enrolled as a student at Stellenbosch University.
- •Provide Informed Consent.
- •Access to internet to join the online group.
排除标准
- •No internet availability.
- •Did not provide Informed Consent
结局指标
主要结局
Change from baseline scores in the mean symptoms of depression as measured by the PHQ-9 at 3-months.
时间窗: Baseline and 3-month follow up assessment for experiment and control interventions groups.
Determine if a 10-week online group CBT (GCBT) intervention effectively reduces mean scores of depression, between baseline and 3-month follow up, among university students when compared with three control group interventions (i.e., Mood Flow, SilverCloud guided, and SilverCloud unguided).
Change from baseline scores in the mean symptoms of anxiety as measured by the GAD-7 at 3-months.
时间窗: Baseline and 3-month follow up assessment for experiment and control interventions groups.
Determine if a 10-week online group CBT (GCBT) intervention effectively reduces mean scores of anxiety, between baseline and 3-month follow up, among university students when compared with three control group interventions (i.e., Mood Flow, SilverCloud guided, and SilverCloud unguided).
次要结局
未报告次要终点
研究者
Jason Bantjes
Professor
University of Stellenbosch