Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Lisa Fortuna, MD
Headshot of Lisa Fortuna
Lisa Fortuna

Description

Summary

Investigators will evaluate the implementation of an evidence-based, Spanish-language, digital, cognitive-behavioral therapy intervention (SilverCloud) in primary care settings for Latino patients with depression and/or anxiety. 426 participants will be enrolled in a two-armed trial comparing self-guided vs. supported dCBT (SilverCloud). At the provider level, investigators will compare the efficacy of provider referrals with the use of a clinic patient registry to identify candidates who could benefit from a digital mental health intervention.

Official Title

SUPERA: Supporting Peer Interactions to Expand Access to Digital Cognitive Behavioral Therapy for Spanish-speaking Safety-Net Patients in Primary Care

Details

The investigators will evaluate the implementation of an evidence-based, Spanish language, digital cognitive-behavioral therapy (dCBT) intervention (SilverCloud) in safety-net primary care clinics for Limited English Proficiency (LEP) Latinx patients with depression and/or anxiety. An effectiveness-implementation hybrid trial (Type 2) design with both provider and patient-level randomization will be conducted. At the provider-level the investigators will compare outreach (using the clinic patient registry) with inreach (traditional provider referral), at the patient-level two modes of delivery of the dCBT platform - supported and unsupported will be compared.

Keywords

Depression, Anxiety, Digital Health Intervention, Mobile Health, Digital Cognitive-Behavioral Therapy, Peer Supporter, Depression, Supported dCBT, Unsupported dCBT

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • Zuckerberg San Francisco General
    San Francisco California 94110 United States
  • University of California
    Berkeley California 94720 United States
  • University of California
    Irvine California 92697 United States

Lead Scientist at UCSF

  • Lisa Fortuna, MD
    Lisa Fortuna, MD, MPH is Professor of Psychiatry and Executive Vice-Chair in the Department of Psychiatry and Behavioral Sciences at UCSF and Chief of Psychiatry at Zuckerberg San Francisco General Hospital. She has been an investigator on several National Institutes of Health and foundation-funded studies of Latinx and immigrant mental health, integrated care, and access to care.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT05746767
Study Type
Interventional
Participants
Expecting 426 study participants
Last Updated