Depression, AnxietySUPERANCT05746767
Supporting Peer Interactions to Expand Access to Digital Cognitive Behavioral Therapy for Spanish-speaking Patients
A study testing Supported dCBT and Unsupported dCBT in people with Depression, Anxiety, run by University of California, Irvine at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Supported dCBT and Unsupported dCBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 11 sitesUnited States
- Study dates
- 14 Mar 2024to 31 Mar 2028
- 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 years and older
- 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
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites
UNMH North Valley Clinic
Albuquerque, New Mexico, 87017
Truman Health Clinic
Albuquerque, New Mexico, 87102
UNM Southeast Heights Clinic
Albuquerque, New Mexico, 87108
University of California
Berkeley, California, 94720
University of California
Irvine, California, 92697
Payson Christian Clinic
Payson, Arizona, 85541
Sandoval Regional Medical Center
Rio Rancho, New Mexico, 87144
Zuckerberg San Francisco General
San Francisco, California, 94110
Castro-Mission Health Center
San Francisco, California, 94114
Silver Avenue Family Health Center
San Francisco, California, 94134
Family and Community Medicine Mobile Health Clinic
Tucson, Arizona, 85711
About this study
Official title: SUPERA: Supporting Peer Interactions to Expand Access to Digital Cognitive Behavioral Therapy for Spanish-speaking Safety-Net Patients in Primary Care
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.
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- Supported dCBT, Unsupported dCBT
- Keywords
- Digital Health Intervention, Mobile Health, Digital Cognitive-Behavioral Therapy, Peer Supporter
- 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.
Supported dCBTBehavioural
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.
Unsupported dCBTBehavioural
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 |
|---|---|---|
| Treatment | Experimental | Participants randomly assigned to this condition will be provided all features of the SilverCloud platform as well as be assigned a peer-supporter who will provide regular support. Receives: Behavioral: Supported dCBT |
| Control | Active comparator | Participants randomly assigned to this condition will be provided all features of the SilverCloud platform with the exception of the peer supporter. Receives: 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
Secondary outcomes (2)
Change in Functioning at 8 Weeks
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).
Measured: Change from Baseline to Week 8
Platform Usage
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.
Measured: Total platform usage 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 posted28 Feb 2023
- Study start14 Mar 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (111)Papers the sponsor has linked to this study.
- 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
- Model description
- Comparing peer-supported delivery vs. unsupported delivery of dCBT
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 426 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Stephen Matthew Schueller, University of California, Irvine
- Investigators
- Stephen M Schueller, PhD, Principal investigator, University of California, IrvineAdrian Aguilera, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746767
- Sponsor's protocol ID
- 1856
- Other IDs
- R01MH126664
- Acronym
- SUPERA
- Status last verified
- May 2026
- First submitted
- 16 Feb 2023
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data will be deposited in a NIH data repository the NIMH Data Archive
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.
PubMed 19921079Falgas 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.
PubMed 26910867Kim 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.
PubMed 20537658Sentell 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(Suppl 2):289-93. doi: 10.1007/s11606-007-0345-7. Epub 2007 Oct 24.
PubMed 17957413Bauer 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.
PubMed 21063226Kazdin 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.
PubMed 26162113Richards 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.
PubMed 22466510National 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/
PubMed 22132433Gilbody S, Littlewood E, Hewitt C, Brierley G, Tharmanathan P, Araya R, Barkham M, Bower P, Cooper C, Gask L, Kessler D, Lester H, Lovell K, Parry G, Richards DA, Andersen P, Brabyn S, Knowles S, Shepherd C, Tallon D, White D; REEACT Team. Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial): large scale pragmatic randomised controlled trial. BMJ. 2015 Nov 11;351:h5627. doi: 10.1136/bmj.h5627.
PubMed 26559241Graham AK, Lattie EG, Powell BJ, Lyon AR, Smith JD, Schueller SM, Stadnick NA, Brown CH, Mohr DC. Implementation strategies for digital mental health interventions in health care settings. Am Psychol. 2020 Nov;75(8):1080-1092. doi: 10.1037/amp0000686.
PubMed 33252946Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
PubMed 22310560Vilsaint CL, NeMoyer A, Fillbrunn M, Sadikova E, Kessler RC, Sampson NA, Alvarez K, Green JG, McLaughlin KA, Chen R, Williams DR, Jackson JS, Alegria M. Racial/ethnic differences in 12-month prevalence and persistence of mood, anxiety, and substance use disorders: Variation by nativity and socioeconomic status. Compr Psychiatry. 2019 Feb;89:52-60. doi: 10.1016/j.comppsych.2018.12.008. Epub 2018 Dec 19.
PubMed 30594752Escovar EL, Craske M, Roy-Byrne P, Stein MB, Sullivan G, Sherbourne CD, Bystritsky A, Chavira DA. Cultural influences on mental health symptoms in a primary care sample of Latinx patients. J Anxiety Disord. 2018 Apr;55:39-47. doi: 10.1016/j.janxdis.2018.03.005. Epub 2018 Mar 12.
PubMed 29576380Wells K, Klap R, Koike A, Sherbourne C. Ethnic disparities in unmet need for alcoholism, drug abuse, and mental health care. Am J Psychiatry. 2001 Dec;158(12):2027-32. doi: 10.1176/appi.ajp.158.12.2027.
PubMed 11729020Brody DS, Khaliq AA, Thompson TL 2nd. Patients' perspectives on the management of emotional distress in primary care settings. J Gen Intern Med. 1997 Jul;12(7):403-6. doi: 10.1046/j.1525-1497.1997.00070.x.
PubMed 9229277
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. 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 Safety-Net Patients in Primary Care
- ClinicalTrials.gov ID
- NCT05746767
- Acronym / sponsor ID
- SUPERA / 1856
- Conditions
- Depression, Anxiety
- Keywords
- Digital Health Intervention, Mobile Health, Digital Cognitive-Behavioral Therapy, Peer Supporter
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 426 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- 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 start
- 14 Mar 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 28 Feb 2023 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparing peer-supported delivery vs. unsupported delivery of dCBT
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Supported dCBTParticipants randomly assigned to this condition will be provided all features of the SilverCloud platform as well as be assigned a peer-supporter who will provide regular support. |
| Control | Active comparator | Behavioral: Unsupported dCBTParticipants randomly assigned to this condition will be provided all features of the SilverCloud platform with the exception of the peer supporter. |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| 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. | Behavioural | Treatment |
| 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. | Behavioural | 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).
2 secondary outcomes
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
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 19 May 2026.
- Background: PubMed 19921079Gonzalez 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.
- Background: PubMed 26910867Falgas 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.
- Background: PubMed 20537658Kim 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.
- Background: PubMed 17957413Sentell 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(Suppl 2):289-93. doi: 10.1007/s11606-007-0345-7. Epub 2007 Oct 24.
- Background: PubMed 21063226Bauer 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.
- Background: PubMed 26162113Kazdin 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.
- Background: PubMed 22466510Richards 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.
- Background: PubMed 22132433National 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/
- Background: PubMed 26559241Gilbody S, Littlewood E, Hewitt C, Brierley G, Tharmanathan P, Araya R, Barkham M, Bower P, Cooper C, Gask L, Kessler D, Lester H, Lovell K, Parry G, Richards DA, Andersen P, Brabyn S, Knowles S, Shepherd C, Tallon D, White D; REEACT Team. Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial): large scale pragmatic randomised controlled trial. BMJ. 2015 Nov 11;351:h5627. doi: 10.1136/bmj.h5627.
- Background: PubMed 33252946Graham AK, Lattie EG, Powell BJ, Lyon AR, Smith JD, Schueller SM, Stadnick NA, Brown CH, Mohr DC. Implementation strategies for digital mental health interventions in health care settings. Am Psychol. 2020 Nov;75(8):1080-1092. doi: 10.1037/amp0000686.
- Background: PubMed 22310560Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
- Background: PubMed 30594752Vilsaint CL, NeMoyer A, Fillbrunn M, Sadikova E, Kessler RC, Sampson NA, Alvarez K, Green JG, McLaughlin KA, Chen R, Williams DR, Jackson JS, Alegria M. Racial/ethnic differences in 12-month prevalence and persistence of mood, anxiety, and substance use disorders: Variation by nativity and socioeconomic status. Compr Psychiatry. 2019 Feb;89:52-60. doi: 10.1016/j.comppsych.2018.12.008. Epub 2018 Dec 19.
- Individual participant dataSharing planned: Yes. Individual Participant Data will be deposited in a NIH data repository the NIMH Data Archive
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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.
Stephen M Schueller, PhD principal investigator
University of California, Irvine
Adrian Aguilera, PhD principal investigator
University of California, Berkeley
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supported dCBT and Unsupported dCBT in people with Depression, Anxiety, run by University of California, Irvine at 11 sites 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: enrolling by invitation, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
On the ClinicalTrials.gov record for NCT05746767, which also lists 111 linked publications.
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 19 May 2026.