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Enrolling By InvitationNCT05746767

Supporting Peer Interactions to Expand Access to Digital Cognitive Behavioral Therapy for Spanish-speaking Patients

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

Status
Enrolling By Invitation
Phase
N/A
Study type
Interventional
Enrollment
426 (estimated)
Sponsor
University of California, Irvine · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSupported dCBTIn 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.
BEHAVIORALUnsupported dCBTUnsupported 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.

Timeline

Start date
2024-03-14
Primary completion
2027-03-01
Completion
2027-03-01
First posted
2023-02-28
Last updated
2026-01-23

Locations

11 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT05746767. Inclusion in this directory is not an endorsement.