Clinical trial NCT05746767: Supporting Peer Interactions to Expand Access to Digital Cognitive Behavioral Therapy for Spanish-speaking Patients
Official title: SUPERA: Supporting Peer Interactions to Expand Access to Digital Cognitive Behavioral Therapy for Spanish-speaking Safety-Net Patients in Primary Care
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression, Anxiety
Keywords: Digital Health Intervention
Mobile Health
Digital Cognitive-Behavioral Therapy
Peer Supporter
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of California, Berkeley
name: University of California, San Francisco
name: University of California, Riverside
name: University of New Mexico
name: University of Arizona
First posted: 2023-02-28
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparing peer-supported delivery vs. unsupported delivery of dCBT
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Depression at 8 Weeks
timeFrame: Change from Baseline to Week 8
measure: Change in Anxiety at 8 Weeks
timeFrame: Change from Baseline to Week 8
Secondary outcomes:
measure: Change in Functioning at 8 Weeks
timeFrame: Change from Baseline to Week 8
measure: Platform Usage
timeFrame: Total platform usage from baseline to Week 8
Other outcomes:
measure: Change in Frequency of Applying CBT-Based Skills at 8 Weeks
timeFrame: Change from Baseline to Week 8
measure: Change in Knowledge of CBT at 8 Weeks
timeFrame: Change from Baseline to Week 8
measure: Change in Psychological Well-Being
timeFrame: Change from Baseline to Week 8
measure: Change in Stress at 8 Weeks
timeFrame: Change from Baseline to Week 8
Locations:
city: Tucson
country: United States
facility: Payson Christian Clinic
state: Arizona
city: Berkeley
country: United States
facility: University of California
state: California
city: Irvine
country: United States
facility: University of California
state: California
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General
state: California
city: Albuquerque
country: United States
facility: Truman Health Services
state: New Mexico
city: Rio Rancho
country: United States
facility: Sandoval Regional Medical Center
state: New Mexico
Study officials:
affiliation: University of California, Irvine
name: Stephen M Schueller, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Berkeley
name: Adrian Aguilera, PhD
role: PRINCIPAL_INVESTIGATOR
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