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

Part of paid clinical trials in Payson, Arizona.

Sponsor
University of California, Irvine
Study ID
NCT05746767
Status
Enrolling By Invitation

Conditions

  • Depression, Anxiety

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Supported dCBT — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Mar 14, 2024
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
426 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Participants randomly assigned to this condition will be provided all features of the SilverCloud platform as well as be assigned a peer-supporter who will provide regular support.
  • Active Comparator: Control
    Participants randomly assigned to this condition will be provided all features of the SilverCloud platform with the exception of the peer supporter.

Primary Outcome Measure

Change in Depression at 8 Weeks [ Time Frame: Change from Baseline to Week 8 ]

Locations (11)

FacilityCityStateZIPSite coordinators
Payson Christian ClinicPaysonArizona85541-
Family and Community Medicine Mobile Health ClinicTucsonArizona85711-
University of CaliforniaBerkeleyCalifornia94720-
University of CaliforniaIrvineCalifornia92697-
Castro-Mission Health CenterSan FranciscoCalifornia94114-
Silver Avenue Family Health CenterSan FranciscoCalifornia94134-
Zuckerberg San Francisco GeneralSan FranciscoCalifornia94110-
Truman Health ClinicAlbuquerqueNew Mexico87102-
UNM Southeast Heights ClinicAlbuquerqueNew Mexico87108-
UNMH North Valley ClinicAlbuquerqueNew Mexico87017-
Sandoval Regional Medical CenterRio RanchoNew Mexico87144-

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