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

Overview

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 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.

Interventions

• 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
• 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.

Primary outcome measures

• Change in Depression at 8 Weeks [Time frame: Change from Baseline to Week 8]
• Change in Anxiety at 8 Weeks [Time frame: Change from Baseline to Week 8]

Secondary outcome measures (2)

• Change in Functioning at 8 Weeks [Time frame: Change from Baseline to Week 8]
• Platform Usage [Time frame: Total platform usage from baseline to Week 8]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 11 centers

• Payson Christian Clinic — Payson
• Family and Community Medicine Mobile Health Clinic — Tucson
• University of California — Berkeley
• University of California — Irvine
• Zuckerberg San Francisco General — San Francisco
• Castro-Mission Health Center — San Francisco
• Silver Avenue Family Health Center — San Francisco
• UNMH North Valley Clinic — Albuquerque
• … and 3 more centers

Publications

• Gonzalez JM, Alegria M, Prihoda TJ, Copeland LA, Zeber JE. How the relationship of attitudes toward mental health treatment and service use differs by age, gender, ethnicity/race and education. Soc Psychiatry Psychiatr Epidemiol. 2011 Jan;46(1):45-57. doi: 10.1007/s00127-009-0168-4. Epub 2009 Nov 17. PMID 19921079
• Falgas I, Ramos Z, Herrera L, Qureshi A, Chavez L, Bonal C, McPeck S, Wang Y, Cook B, Alegria M. Barriers to and Correlates of Retention in Behavioral Health Treatment Among Latinos in 2 Different Host Countries: The United States and Spain. J Public Health Manag Pract. 2017 Jan/Feb;23(1):e20-e27. doi: 10.1097/PHH.0000000000000391. PMID 26910867
• Kim G, Aguado Loi CX, Chiriboga DA, Jang Y, Parmelee P, Allen RS. Limited English proficiency as a barrier to mental health service use: a study of Latino and Asian immigrants with psychiatric disorders. J Psychiatr Res. 2011 Jan;45(1):104-10. doi: 10.1016/j.jpsychires.2010.04.031. Epub 2010 May 26. PMID 20537658
• Sentell T, Shumway M, Snowden L. Access to mental health treatment by English language proficiency and race/ethnicity. J Gen Intern Med. 2007 Nov;22 Suppl 2:289-93. doi: 10.1007/s11606-007-0345-7. Epub 2007 Oct 24. PMID 17957413
• Bauer AM, Chen CN, Alegria M. English language proficiency and mental health service use among Latino and Asian Americans with mental disorders. Med Care. 2010 Dec;48(12):1097-104. doi: 10.1097/MLR.0b013e3181f80749. PMID 21063226
• Kazdin AE, Blase SL. Rebooting Psychotherapy Research and Practice to Reduce the Burden of Mental Illness. Perspect Psychol Sci. 2011 Jan;6(1):21-37. doi: 10.1177/1745691610393527. Epub 2011 Feb 3. PMID 26162113
• Richards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012 Jun;32(4):329-42. doi: 10.1016/j.cpr.2012.02.004. Epub 2012 Feb 28. PMID 22466510
• National Collaborating Centre for Mental Health (UK). Depression: The Treatment and Management of Depression in Adults (Updated Edition). Leicester (UK): British Psychological Society; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK63748/ PMID 22132433

Identifiers

NCT: NCT05746767 · 1856 · R01MH126664

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗