Depression, AnxietySUPERANCT07186816
SUpport From PEeRs to Expand Access Study - Community
A study testing Behavioral: Supported dCBT and Behavioral: Unsupported dCBT in people with Depression, Anxiety, run by University of California, Berkeley at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Behavioral: Supported dCBT and Behavioral: Unsupported dCBT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Zuckerberg San Francisco General
San Francisco, California, 94110
Aguilera, 650-784-5939, aguila@berkeley.edu
About this study
Official title: SUPERA: Supporting Peer Interactions to Expand Access to Digital Cognitive Behavioral Therapy for Spanish-speaking in the San Francisco Mission Community
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).
- Conditions
- Depression, Anxiety
- Being tested
- Behavioral: Supported dCBT, Behavioral: Unsupported dCBT
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Supported dCBTDevice
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.
Behavioral: Unsupported dCBTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Peer-Support | Experimental | Not described Receives: Device: Behavioral: Supported dCBT |
| Control | Active comparator | Not described Receives: Device: Behavioral: Unsupported dCBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from Baseline to Week 8
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).
Measured: Change from Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start18 Aug 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186816
- Sponsor's protocol ID
- 22-36825
- Acronym
- SUPERA
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUPERA: Supporting Peer Interactions to Expand Access to Digital Cognitive Behavioral Therapy for Spanish-speaking in the San Francisco Mission Community
- ClinicalTrials.gov ID
- NCT07186816
- Acronym / sponsor ID
- SUPERA / 22-36825
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- University of California, Irvine, University of California, San Francisco
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer-Support | Experimental | Device: Behavioral: Supported dCBT |
| Control | Active comparator | Device: Behavioral: Unsupported dCBT |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral: Supported dCBTIn 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. | Device | Peer-Support |
| Behavioral: Unsupported dCBTUnsupported 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. | Device | Control |
Primary outcome
Change in Depression at 8 Weeks
Time frame: 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
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Supported dCBT and Behavioral: Unsupported dCBT in people with Depression, Anxiety, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression at 8 Weeks (time frame: Change from Baseline to Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.