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.
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 patient-level randomization. The implementation comparison will evaluate a non-randomized comparison between outreach (using the clinic patient registry) with inreach (traditional provider referral). The effectiveness comparison will include randomization at the patient-level to two modes of delivery of the dCBT platform - supported and unsupported will be compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
426
In the supported dCBT condition, each patient will receive complete access to the SilverCloud platform. In addition, patients will be assigned a supporter who will provide regular support based on an established coaching support protocol. Supporters will conduct a brief engagement call (30-40 minutes) to provide an overview of SilverCloud, identify goals, and set expectations, introduce themselves, and orient the participant to the role of the peer supporter. Supporters will then provide weekly check-ins through phone calls or messaging. Participants will be able to communicate with the supporters through the platform through messaging or sharing activities for additional discussion. The major goal of the support is to promote use of the platform.
Unsupported dCBT provides all features of the SilverCloud platform with the exception of support features (structured interactions with supporter and share features). Patients will be provided complete access to SilverCloud and instructed to use it for 8-weeks. Patients will receive weekly automated messages to encourage engagement.
Payson Christian Clinic
Payson, Arizona, United States
Family and Community Medicine Mobile Health Clinic
Tucson, Arizona, United States
University of California
Berkeley, California, United States
University of California
Irvine, California, United States
Zuckerberg San Francisco General
San Francisco, California, United States
Castro-Mission Health Center
San Francisco, California, United States
Silver Avenue Family Health Center
San Francisco, California, United States
UNMH North Valley Clinic
Albuquerque, New Mexico, United States
Truman Health Clinic
Albuquerque, New Mexico, United States
UNM Southeast Heights Clinic
Albuquerque, New Mexico, United States
...and 1 more locations
Change in Depression at 8 Weeks
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).
Time frame: Change from Baseline to Week 8
Change in Anxiety at 8 Weeks
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).
Time frame: Change from Baseline to Week 8
Change in Functioning at 8 Weeks
Functioning will be assessed with the World Health Organization Disability Assessment Schedule (WHODAS) a 36-item self-report measure that assesses disability across six domains, including understanding and communicating, getting around, self-care, getting along with people, life activities (i.e., household, work, and/or school activities), and participation in society. Scores on this measure range from 1 (none) to 5 (extreme).
Time frame: Change from Baseline to Week 8
Platform Usage
Platform usage will be defined as time spent on the platform. Platform usage will vary from 0 minutes to the highest number of minutes any participants spends on the platform.
Time frame: Total platform usage from baseline to Week 8
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