SUpport From PEeRs to Expand Access Study - Community
Recruiting · NCT07186816 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, Berkeley
View the official record on ClinicalTrials.gov →Interventions studied
Behavioral: Supported dCBTBehavioral: Unsupported dCBT
What this trial is about
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).
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
2 locations listed across 1 US state.
- Zuckerberg San Francisco General - San Francisco, California, United States
- Zuckerberg San Francisco General - San Francisco, California, United States