Peer support to expand access to Spanish digital cognitive behavioral therapy in the Mission community

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The project will enroll 213 Spanish-preferring adults in San Francisco's Mission community with elevated depression (PHQ-9 ≥10) or anxiety (GAD-7 ≥8). Participants will use SilverCloud, a Spanish-language digital cognitive behavioral therapy program, with assignment to supported (peer-assisted) or unsupported (self-guided) delivery within a one-armed implementation design. The intervention is delivered online and requires smartphone or home internet access and basic tech literacy, with brief training offered if needed; participants currently in psychotherapy are excluded and antidepressant use is allowed if dose is stable. Outcomes will include changes in symptom scores and measures of program engagement and implementation to inform broader community rollout.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. PHQ-9 ≥ 10 or GAD-7 ≥ 8
2. 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
3. ≥18 years of age
4. Preference for receiving medical care in Spanish
5. Not in concurrent psychotherapy
6. 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:

1. 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
2. Visual, hearing, voice, or motor impairment or illiteracy that would prevent completion of study procedures
3. Diagnosis of a psychotic disorder, bipolar disorder, dissociative disorder, or substance use disorder
4. 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's running

• Zuckerberg San Francisco General
  San Francisco, California, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.