Examining the Effectiveness of Wysa's Computerized Cognitive Behavioral Therapy Program (a Digital Mental Health Intervention) in Reducing Symptoms of Anxiety: Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Wysa
- 入组人数
- 500
- 主要终点
- Change in scores of Generalized Anxiety Disorder Scale (GAD-7)
研究概览
简要总结
The goal of this randomized controlled trial is to test for the effectiveness of Wysa's Worry computerized cognitive behaviour therapy (cCBT) program (a digital mental health intervention) in comparison to a digital app that offers psychoeducation to patients who have mild to moderate symptoms of anxiety.
详细描述
People dealing with worry can receive augmented support from digital mental health interventions. The intervention being tested in this study is Wysa's Worry cCBT program. Its outcomes will be compared to a randomized, controlled arm that offers psychoeducation.
For the purpose of this study participants will be recruited through different online channels and will be randomly assigned to either the intervention or control group. Regardless of their assignment they will be completing weekly standardized assessments examining their symptoms of anxiety and depression, and examining any improvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •The inclusion criteria for the study is as follows:
- •Patients who are at least 18 years of age.
- •Patients who have mild to moderate symptoms of anxiety (scores: 5-15, according to GAD-7).
- •Patients who are not already engaged in psychological therapy and not intending to start psychological therapy in the next eight weeks.
- •Patients who haven't used any DMHI (Digital Mental Health Interventions) in the last 6 months.
- •Patients without risk of suicidal ideation and behaviour.
- •Patients who are capable of reading and understanding English and have provided written or verbal informed consent to participate.
- •Patients who own and use a smartphone with functional audio.
排除标准
- •Patients who are at an increased risk of suicide.
- •Patients with diagnosis of or receiving treatment for alcohol/substance use disorder.
- •Patients who've had their psychiatric medication or dose changed in the last 1 month.
- •Patients who suffer from severe anxiety
- •Patients with diagnosis of or receiving treatment for an active state of psychosis.
结局指标
主要结局
Change in scores of Generalized Anxiety Disorder Scale (GAD-7)
时间窗: Baseline, Weekly assessments for 7 weeks, Post intervention assessment (one month after the participant finishes the intervention)
GAD-7 is a 7 item assessment that screens for anxiety and assesses the severity of anxiety symptoms.
次要结局
- Change in scores of Patient Health Questionnaire-9 (PHQ-9)(Baseline, Weekly assessments for 7 weeks, Post intervention assessment (one month after the participant finishes the intervention))