Depression, Anxiety
Conditions
Keywords
Digital Health Intervention, Mobile Health, Digital Cognitive-Behavioral Therapy, Peer Supporter
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 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
BEHAVIORALSupported 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.
BEHAVIORALUnsupported 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.
Sponsors
University of California, Irvine
National Institute of Mental Health (NIMH)
University of California, Berkeley
University of California, San Francisco
University of California, Riverside
University of New Mexico
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Comparing peer-supported delivery vs. unsupported delivery of dCBT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStephen M Schueller, PhD
University of California, Irvine
PRINCIPAL_INVESTIGATORAdrian Aguilera, PhD
University of California, Berkeley
Outcome results
None listed