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Enrolling by Invitation

NCT Number: NCT05746767

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

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.

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Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Payson Christian Clinic, Payson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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).

  2. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SUPERA

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 28, 2023
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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