SUpport From PEeRs to Expand Access Study - Community
ConditionDepression, Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of California, Berkeley
About this trial
Investigators will evaluate the implementation of an evidence-based, Spanish-language, digital, cognitive-behavioral therapy (dCBT) intervention (SilverCloud) in the Mission community for Latino patients with depression and/or anxiety. 213 participants will be enrolled in a one-armed trial comparing self-guided vs. supported dCBT (SilverCloud).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Behavioral: Supported dCBT
DeviceIn 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.
Behavioral: Unsupported dCBT
DeviceUnsupported 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.
Treatment groups
213 Participants
are divided into 2 treatment groupsGroup A: Peer-SupportExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Depression at 8 Weeks
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).
Time frame
Change from Baseline to Week 82
Change in Anxiety at 8 Weeks
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).
Time frame
Change from Baseline to Week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Berkeley
Lead sponsor
University of California, Irvine
Collaborator
University of California, San Francisco
Collaborator
Source ClinicalTrials.gov