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

Not Applicable

• Conditions: Depression, Anxiety
• Interventions: Behavioral: Supported dCBT; Behavioral: Unsupported dCBT

• Registration Number: NCT05746767
• Lead Sponsor: University of California, Irvine

Brief 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 both provider and patient-level randomization will be conducted. At the provider-level the investigators will compare outreach (using the clinic patient registry) with inreach (traditional provider referral), at the patient-level two modes of delivery of the dCBT platform - supported and unsupported will be compared.

Study Timeline

• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-28
• Study Start: 2024-03-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09
• Primary Completion: 2027-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 426

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Supported dCBT	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.
Control	Unsupported dCBT	Participants randomly assigned to this condition will be provided all features of the SilverCloud platform with the exception of the peer supporter.

Primary Outcome Measures

Name	Time	Method
Change in Depression at 8 Weeks	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 in Anxiety at 8 Weeks	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 Outcome Measures

Name	Time	Method
Change in Functioning at 8 Weeks	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).
Platform Usage	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.

Trial Locations

Locations (2)

University of California; 🇺🇸 Irvine, California, United States

Zuckerberg San Francisco General; 🇺🇸 San Francisco, California, United States