Supported Digital CBT for Depression and Anxiety

(SUPERA Trial)

Enrolling by invitation at 6 trial locations

Overseen By Stephen M Schueller, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Psychotic, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online therapy program, SilverCloud, to determine its effectiveness for Latino patients with depression or anxiety. It compares two groups: one receives regular peer support while using the program, and the other uses the program without additional support. The researchers aim to discover whether provider referrals or patient registries more effectively identify those who could benefit from digital mental health tools like digital Cognitive Behavioral Therapy (dCBT). Participants should be Spanish speakers with stable internet access and not currently in therapy. This trial may suit individuals feeling down or anxious who prefer receiving medical care in Spanish. As an unphased trial, it offers a unique opportunity to contribute to understanding how digital tools can enhance mental health care for the Latino community.

Will I have to stop taking my current medications?

If you are taking an antidepressant, you can continue as long as your dose has been stable for at least 6 weeks and you don't plan to change it. The trial will monitor your medication status during the study.

What prior data suggests that this digital cognitive-behavioral therapy is safe for Latino patients with depression and/or anxiety?

Research has shown that digital cognitive-behavioral therapy (dCBT), such as the SilverCloud platform, is generally safe for treating anxiety and depression. Some studies have found that dCBT can reduce symptoms of anxiety and depression, sometimes more effectively than traditional methods. For instance, one study reported a 20% decrease in anxiety symptoms and a 21% reduction in depression symptoms.

Another study found that dCBT was safe and effective for anxiety compared to no treatment. Importantly, using dCBT did not increase the risk of suicidal thoughts or actions, although these events were very rare.

Overall, dCBT is well-received, showing positive effects on mental health without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Supported Digital CBT for Depression and Anxiety trial because it explores a unique approach to enhancing digital cognitive behavioral therapy (dCBT). Unlike traditional CBT options, which typically involve face-to-face sessions with a therapist, this digital method utilizes the SilverCloud platform, providing patients with access to therapy anytime, anywhere. A standout feature of this trial is the addition of a peer-supporter for some participants, offering regular support and potentially increasing engagement and effectiveness. This peer-support aspect is what sets it apart from existing digital methods, providing a more personalized and supportive experience.

What evidence suggests that this digital CBT is effective for depression and anxiety?

Research has shown that digital cognitive behavioral therapy (dCBT) effectively treats depression and anxiety. Studies have found that digital mental health programs can reduce symptoms of these conditions, offering a convenient and accessible option for many. In this trial, participants will be assigned to different conditions to evaluate the effectiveness of dCBT. One group will receive dCBT with peer-supporter assistance, while the other group will receive dCBT without this additional support. Evidence supports using digital programs with a coach, which can boost participation and improve emotional well-being. Overall, digital CBT is considered a valuable and effective way to manage depression and anxiety. ^{5 6 7 8 9}

Who Is on the Research Team?

Stephen M Schueller, PhD

Principal Investigator

University of California, Irvine

Adrian Aguilera, PhD

Principal Investigator

University of California, Berkeley

Are You a Good Fit for This Trial?

This trial is for Spanish-speaking adults with moderate depression or anxiety, not currently in psychotherapy but possibly on stable antidepressants. They must be over 18, have internet access, and be comfortable with technology or willing to learn. Excluded are those with severe mental health disorders, substance abuse issues, severe suicidality, or impairments that hinder study participation.

Inclusion Criteria

I am not currently in psychotherapy.

I prefer to receive medical care in Spanish.

I have been on the same dose of antidepressant for at least 6 weeks and don't plan to change it.

Exclusion Criteria

I am currently in psychotherapy for depression or anxiety.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive digital cognitive-behavioral therapy (dCBT) intervention using the SilverCloud platform, with or without peer support

8 weeks

Regular virtual check-ins

Follow-up

Participants are monitored for changes in stress, functioning, platform usage, application of CBT skills, knowledge of CBT, psychological well-being, depression, and anxiety

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• dCBT

Trial Overview The study compares two approaches of digital Cognitive Behavioral Therapy (dCBT) for Latino patients: one self-guided and the other supported by healthcare providers. It also examines different referral methods—direct provider referrals versus using a patient registry—to see which is more effective at identifying candidates for dCBT.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 Intervention

Participants randomly assigned to this condition will be provided all features of the SilverCloud platform with the exception of the peer supporter.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

University of California, Riverside

Collaborator

Trials

33

Recruited

14,400+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+

University of Arizona

Collaborator

Trials

545

Recruited

161,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of California, Berkeley

Collaborator

Trials

193

Recruited

716,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

Computerised cognitive behaviour therapy (cCBT) has been shown to effectively reduce depressive symptoms, comparable to face-to-face therapy, and is more effective than waiting lists or standard treatment.

This study will explore how different types of human support (brief vs. extended, expert vs. assistant) impact the effectiveness and acceptability of cCBT, using a sample of 200 adults with non-suicidal depression to ensure robust results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerised therapy for depression with clinician vs. assistant and brief vs. extended phone support: study protocol for a randomised controlled trial. Gega, L., Swift, L., Barton, G., et al.[2021]

Digital cognitive-behavioral therapy (dCBT) showed a slight improvement in depression symptoms immediately after treatment compared to control groups, based on a review of 12 trials involving 1,575 adolescents.

There was no significant increase in suicidal attempts or ideation associated with dCBT, indicating it may be a safe option, although the evidence on safety is limited and further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Evidence Review of Digital Cognitive-Behavioral Therapy for Adolescents With Depression. Ivlev, I., Beil, TL., Haynes, JS., et al.[2022]

Computerized cognitive behavior therapy (cCBT) shows potential as an effective treatment for depression in individuals with chronic physical health problems, based on a systematic review of randomized controlled trials, although only one study specifically focused on diabetes was included.

The single study indicated positive outcomes compared to a waiting-list control, but it also faced challenges such as high participant dropout rates, suggesting that cCBT may not be acceptable to all and highlighting the need for more comprehensive research to confirm its efficacy and feasibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive behaviour therapy for depression in people with a chronic physical illness. Sharp, J., Holly, D., Broomfield, N.[2018]

Digital cognitive behavioral therapy (dCBT) has shown strong evidence for effectively treating insomnia, with significant short-term benefits and lasting effects observed for up to 1.5 years across various populations.

Incorporating personalized guidance into dCBT may enhance its effectiveness, indicating that dCBT is ready for standard healthcare implementation, although further research and innovative methods are needed for optimal application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Delivery of Cognitive Behavioral Therapy for Insomnia. Luik, AI., van der Zweerde, T., van Straten, A., et al.[2020]

In a pilot study involving 82 adults, blended cognitive behavioral therapy (bCBT) showed larger improvements in depressive symptoms compared to standard cognitive behavioral therapy (CBT), although these differences were not statistically significant.

bCBT demonstrated superior outcomes in secondary measures of psychological health and anxiety symptoms, suggesting it may offer additional benefits over traditional CBT, warranting further investigation in larger randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the effectiveness of CBT for patients with unipolar depression by integrating digital interventions into treatment: A pilot randomized controlled trial. Kalde, J., Atik, E., Stricker, J., et al.[2023]

Citations

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

Digital Cognitive Behavior Therapy Intervention for ... Digital mental health interventions offer a scalable solution that reduces barriers to seeking care for clinical depression and anxiety.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40526910/

Effectiveness of Digital Behavioral Activation Interventions for ... Digital BA interventions are effective in reducing depressive symptoms and improving QoL in the short- to midterm.

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

A systematic review of digital and face-to-face cognitive ... Cognitive behavioral therapy (CBT) represents one of the major treatment options for depressive disorders besides pharmacological ...

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

Effects of digital psychotherapy for depression and anxiety Cognitive behavioral therapy is the most widely used digital technology for relieving depression and anxiety symptoms. •. Digital exercise ...

5. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ps.202200045

A Digital Cognitive-Behavioral Intervention for Depression ... The authors evaluated engagement in and effects of a coach-enhanced digital cognitive-behavioral intervention (dCBI; RxWell) targeting emotional distress in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10760511/

Efficacy of an Electronic Cognitive Behavioral Therapy ... Slightly greater reductions of 19.74% in anxiety symptoms and 20.80% in depression symptoms were observed in the intention-to-treat analysis.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32725848/

Efficacy of digital cognitive behavioral therapy for moderate ... Digital CBT (Daylight) appears to be safe and efficacious for symptoms of anxiety, worry, and further measures of mental health compared with waitlist control.

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 ... The use of dCBT did not appear to result in an increased risk for suicidal attempts or ideation; however, the number of events was very small.