SUPERA: Supporting Peer Interactions to Expand Access to Digital Cognitive Behavioral Therapy for Spanish-speaking in the San Francisco Mission Community
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 213
- 试验地点
- 2
- 主要终点
- Change in Depression at 8 Weeks
研究概览
简要总结
Investigators will evaluate the implementation of an evidence-based, Spanish-language, digital, cognitive-behavioral therapy (dCBT) intervention (SilverCloud) in the Mission community for Latino patients with depression and/or anxiety. 213 participants will be enrolled in a one-armed trial comparing self-guided vs. supported dCBT (SilverCloud).
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PHQ-9 ≥ 10 or GAD-7 ≥ 8
- •Has access to the Internet via smartphone and/or broadband at home, and basic level of technological literacy or willingness to undergo a brief technology use training
- •≥18 years of age
- •Preference for receiving medical care in Spanish
- •Not in concurrent psychotherapy
- •If currently taking an antidepressant medication, patient must have been on a stable dose for at least 6 weeks, and have no plans to change the dose. We will permit patients on antidepressants to enter the study, as this will increase generalizability. Antidepressant status will be monitored at each assessment to control for those effects, if necessary.
排除标准
- •Currently receiving psychotherapy, as this treatment will be offered as a frontline treatment for depression and anxiety, however, patients are allowed to be referred to treatment while participating in this study and initiation of treatment will be monitored and considered in analyses
- •Visual, hearing, voice, or motor impairment or illiteracy that would prevent completion of study procedures
- •Diagnosis of a psychotic disorder, bipolar disorder, dissociative disorder, or substance use disorder
- •Severe suicidality (as assessed by expressing suicidal ideation, plan, and intent). Although procedures with back-up plans are in place for patients who develop suicidality (see Human Subjects Section), patients assessed with severe suicidality will be referred to more-intensive treatment resources.
结局指标
主要结局
Change in Depression at 8 Weeks
时间窗: Change from Baseline to Week 8
The primary outcome of symptoms of depression will be measured with the self-report Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report measure of depression. Scores on this measure range from 0 (Not At All) to 3 (Nearly Every Day).
Change in Anxiety at 8 Weeks
时间窗: Change from Baseline to Week 8
The primary outcome of symptoms of depression will be measured with the self-report General Anxiety Disorder-7 (GAD-7). The GAD-7 is a 7-item self-report measure of anxiety. Scores on this measure range from 0 (Not At All) to 3 (Nearly Every Day).
次要结局
未报告次要终点