Supported Digital CBT for Depression and Anxiety

(SUPERA Trial)

Recruiting 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

426 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is digital CBT safe for humans?

Research on digital cognitive behavioral therapy (dCBT) for conditions like depression and insomnia suggests it is generally safe for humans, with no major safety concerns reported in studies. ^{1 2 3 4 5}

How is Supported Digital CBT for Depression and Anxiety different from other treatments?

Supported Digital CBT (dCBT) for depression and anxiety is unique because it combines the accessibility of digital platforms with the structured techniques of cognitive behavioral therapy (CBT), making it more convenient and potentially more engaging for users. Unlike traditional face-to-face therapy, dCBT can be accessed anytime and anywhere, and it often includes multimedia elements to enhance the therapeutic experience. ^{1 4 5 6 7}

What data supports the effectiveness of the treatment dCBT for depression and anxiety?

Research shows that computer-delivered cognitive behavioral therapy (CCBT), which is similar to dCBT, is effective for treating depression and anxiety. Studies have found that with proper guidance, the results of CCBT are comparable to traditional face-to-face therapy, making it a promising option for improving access to mental health care. ^{1 4 5 7 8}

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 prefer to receive medical care in Spanish.

I am not currently in psychotherapy.

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

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]

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) 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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Computerized cognitive behavioural therapy and the therapeutic alliance: a qualitative enquiry. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Digital Delivery of Cognitive Behavioral Therapy for Insomnia. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Patient experience of computerised therapy for depression in primary care. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Computer-delivered cognitive behavioural therapy: effective and getting ready for dissemination. [2021]

5. England 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Computerized cognitive behaviour therapy for depression in people with a chronic physical illness. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Rapid Evidence Review of Digital Cognitive-Behavioral Therapy for Adolescents With Depression. [2022]

8. England 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. [2021]