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

May 15, 2026 updated by: Stephen Matthew Schueller, University of California, Irvine

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

426

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Payson, Arizona, United States, 85541
        • Payson Christian Clinic
      • Tucson, Arizona, United States, 85711
        • Family and Community Medicine Mobile Health Clinic
    • California
      • Berkeley, California, United States, 94720
        • University of California
      • Irvine, California, United States, 92697
        • University of California
      • San Francisco, California, United States, 94110
        • Zuckerberg San Francisco General
      • San Francisco, California, United States, 94114
        • Castro-Mission Health Center
      • San Francisco, California, United States, 94134
        • Silver Avenue Family Health Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87017
        • UNMH North Valley Clinic
      • Albuquerque, New Mexico, United States, 87102
        • Truman Health Clinic
      • Albuquerque, New Mexico, United States, 87108
        • UNM Southeast Heights Clinic
      • Rio Rancho, New Mexico, United States, 87144
        • Sandoval Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  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.

Exclusion Criteria:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Supported dCBT
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.
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.
Behavioral: Unsupported dCBT
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression at 8 Weeks
Time Frame: Change from Baseline to Week 8
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
Time Frame: Change from Baseline to Week 8
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platform Usage
Time Frame: Total platform usage from baseline to Week 8
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.
Total platform usage from baseline to Week 8
Change in Functioning at 8 Weeks
Time Frame: Change from Baseline to Week 8
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).
Change from Baseline to Week 8

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Frequency of Applying CBT-Based Skills at 8 Weeks
Time Frame: Change from Baseline to Week 8
Frequency of Actions and Thoughts Scale (FATS). A 12-item measure that will be used to assess how frequently the participants apply CBT-based skills. Higher score means that the respondent has higher frequency of applying the CBT-based skills they learned.
Change from Baseline to Week 8
Change in Knowledge of CBT at 8 Weeks
Time Frame: Change from Baseline to Week 8
Knowledge Gain in CBT. A 16-item survey that will be used to assess changes in knowledge about CBT therapy. Higher score means that the respondent has higher knowledge of CBT skills.
Change from Baseline to Week 8
Change in Psychological Well-Being
Time Frame: Change from Baseline to Week 8
Psychological Well-Being will be assessed with the Brief Inventory of Thriving (BIT) a 10-item self-report measure. Scores on this measure range from 5 (low level of thriving) to 50 (high level of thriving).
Change from Baseline to Week 8
Change in Stress at 8 Weeks
Time Frame: Change from Baseline to Week 8
Stress will be assessed with the Perceived Stress Scale (PSS-4) a 4-item self-report measure that assesses feelings and thoughts that people are experiencing related to their experience of stress. Scores on this measure range from 0 (no perceived stress) to 16 (high perceived stress).
Change from Baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

National Institute of Mental Health (NIMH)
University of California, Berkeley
University of California, San Francisco
University of Arizona
University of New Mexico
University of California, Riverside

Investigators

  • Principal Investigator: Adrian Aguilera, PhD, University of California, Berkeley
  • Principal Investigator: Stephen M Schueller, PhD, University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Actual)

February 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1856
  • R01MH126664 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual Participant Data will be deposited in a NIH data repository the NIMH Data Archive

IPD Sharing Time Frame

Descriptive data will be submitted every six months. Analyzed datasets on study outcomes will be deposited in the repository as soon as possible but no later than within one year of the completion of the project. No end date on data availability.

IPD Sharing Access Criteria

Anyone who wishes to access the data and adheres to the NIMH Data Archive policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression, Anxiety

Clinical Trials on Supported dCBT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe