Digital CBT for Depression and Anxiety

(SUPERA Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Berkeley

Disqualifiers: Psychotic disorder, Bipolar, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

213 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a Spanish-language digital cognitive-behavioral therapy (dCBT) program called SilverCloud. It will explore whether self-guided or peer-supported dCBT works better for Latino patients dealing with depression or anxiety. Individuals with depression or anxiety who prefer receiving medical care in Spanish and aren't currently in therapy might be a good fit. Participants need internet access and should be comfortable using technology or willing to learn.

As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research tailored to their language and cultural needs.

Will I have to stop taking my current medications?

If you're taking an antidepressant, you can continue as long as you've been on a stable dose for at least 6 weeks and don't plan to change it. The trial doesn't specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that digital cognitive-behavioral therapy (dCBT) is generally safe for treating depression and anxiety. In past studies, dCBT improved depression symptoms, even for individuals with long-term physical health issues, indicating it is well-tolerated. For instance, a study with 1,512 participants found that digital CBT improved depression symptoms without causing serious side effects.

Other research has demonstrated that digital treatments for insomnia also reduced depression and anxiety symptoms. This suggests that dCBT can be safely used for various mental health problems. Participants in these studies reported feeling better without significant negative effects.

Overall, dCBT, whether guided by peers or done independently, appears safe based on these findings. Participants usually experience improved mood and quality of life, with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about digital CBT (dCBT) for depression and anxiety because it offers a flexible and accessible way to manage mental health. Unlike traditional therapy, which often involves in-person sessions that can be costly and time-consuming, dCBT can be accessed online, allowing people to engage with therapy from the comfort of their own home. This digital approach can be either supported, with guidance from a therapist or peer, or unsupported, allowing individuals to navigate the program independently. This versatility makes mental health support more attainable for those with busy schedules or limited access to mental health professionals.

What evidence suggests that this trial's treatments could be effective for depression and anxiety?

This trial will compare two forms of digital cognitive behavioral therapy (dCBT) for depression and anxiety: Supported dCBT and Unsupported dCBT. Studies have shown that dCBT can effectively reduce symptoms of these conditions. Research indicates that therapist-supported dCBT helps patients achieve lasting and meaningful improvements. Multiple studies highlight that guided digital therapy can significantly reduce anxiety and depression symptoms. For dCBT without therapist support, findings suggest it improves accessibility and engagement while remaining effective. Overall, both supported and unsupported dCBT show promise in helping individuals with depression and anxiety. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for Latino patients in the Mission community who are experiencing depression and/or anxiety. Participants will use a Spanish-language digital cognitive-behavioral therapy program called SilverCloud.

Inclusion Criteria

I am 18 years old or older.

I prefer to receive medical care in Spanish.

I am not currently in psychotherapy.

Exclusion Criteria

I have not expressed severe thoughts or plans about suicide.

I am currently undergoing psychotherapy.

Visual, hearing, voice, or motor impairment or illiteracy that would prevent completion of study procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in digital cognitive-behavioral therapy (dCBT) using SilverCloud, with options for self-guided or peer-supported formats

8 weeks

Follow-up

Participants are monitored for changes in depression and anxiety symptoms after the treatment phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Supported dCBT
• Unsupported dCBT

Trial Overview The study is examining how effective SilverCloud, a digital cognitive-behavioral therapy tool, is when used with support from peers versus without support. All 213 participants will try both self-guided and supported versions of dCBT.

How Is the Trial Designed?

Group I: Peer-Support Experimental Treatment 1 Intervention

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, Berkeley

Lead Sponsor

Trials

193

Recruited

716,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7481876/

Digital Cognitive Behavior Therapy Intervention for ... The results suggest that digital interventions can support sustained and clinically meaningful improvements in depression and anxiety.

2. medrxiv.org medrxiv.org/content/10.1101/2025.08.08.25333326v1.full.pdf

Digital Cognitive Behavioral Therapy in Anxiety Disorders Results: Multiple RCTs and meta-analyses have demonstrated that dCBT is signiCicantly effective in reducing generalized anxiety disorder (GAD), ...

3. nature.com nature.com/articles/s41746-022-00677-8

A systematic review of digital and face-to-face cognitive ... A number of studies suggest that CBT can effectively reduce depressive symptoms, anxiety or psychosocial functioning6,7,8,9,10,11,12,13. In line ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032723008236

Effects of digital psychotherapy for depression and anxiety For baseline-to-12-month dimensional outcomes, guided i-CBT produced greater reductions in anxiety, depressive, post-traumatic stress disorder ...

5. icr-heart.com icr-heart.com/article/effectiveness-of-digital-cognitive-behavioral-therapy-in-managing-adolescent-depression-a-randomized-controlled-trial-2428/

Effectiveness of Digital Cognitive Behavioral Therapy in ... These findings suggest that digital CBT significantly reduces depressive and anxiety symptoms and improves quality of life compared to standard ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11943665/

Next-Generation Cognitive-Behavioral Therapy for Depression A digital CBT intervention improved depression outcomes in a population with chronic physical conditions. Total: 1512, -Structured digital lessons ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1551714423003452

Effectiveness-implementation hybrid trial of Spanish ... We hypothesize that peer-supported dCBT will result in greater improvement in mental health symptoms and higher patient engagement compared to ...

8. nature.com nature.com/articles/s41746-023-00800-3

Digital cognitive behavioral therapy for insomnia on ... The results demonstrated that digital intervention for insomnia yielded significant effects on alleviating depressive and anxiety symptoms as well as insomnia ...

9. jahonline.org jahonline.org/article/S1054-139X(22)00279-8/fulltext

Rapid Evidence Review of Digital Cognitive-Behavioral ... A limited body of evidence suggests that dCBT programs might outperform control interventions for reducing depressive symptoms immediately post-intervention.