SUpport From PEeRs to Expand Access Study - Community

NCT07186816 | Recruiting DMC

• 1 other identifier: 22-36825
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Change from Baseline to Week 8

Study Arms (2)

Peer-Support

EXPERIMENTAL

Device: Behavioral: Supported dCBT

Control

ACTIVE COMPARATOR

Device: Behavioral: Unsupported dCBT

Interventions

Behavioral: Supported dCBT DEVICE

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.

Peer-Support

Behavioral: Unsupported dCBT DEVICE

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.

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Berkeley: lead
• University of California, Irvine: collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

Zuckerberg San Francisco General

San Francisco, California, 94110, United States

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 22, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

US (1)