Digital Therapy for Suicide Prevention

Overseen By Michelle Wine, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Memphis

Disqualifiers: Active psychosis, Mania, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital therapy app called Aviva, designed to assist servicemembers who have recently considered or attempted suicide. The researchers aim to determine if Aviva can more effectively reduce suicidal thoughts compared to usual care, which involves creating a safety plan and receiving standard mental health support. Suitable candidates for this trial include those who have experienced suicidal thoughts in the past week or a suicide attempt in the past month and possess a compatible smartphone. Participants will use the app, which includes therapy sessions, over 8 weeks and will have follow-ups for up to a year. The trial seeks to enhance access to effective suicide prevention strategies through technology. As an unphased trial, this study offers participants the chance to contribute to innovative research that could transform mental health care for servicemembers.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications, so it's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this digital therapy is safe for suicide prevention?

Research has shown that Aviva, a digital therapy using brief cognitive behavioral therapy (BCBT), has shown promise in earlier studies. Previous patients found it safe and easy to use. In a study where all participants knew they were receiving Aviva, they completed therapy sessions over eight weeks, and follow-ups confirmed its safety and practicality.

Aviva is based on BCBT, which earlier research has proven to significantly reduce suicide attempts. In fact, BCBT has been more effective in preventing suicide attempts and deaths compared to other treatments.

While Aviva is still being tested, the therapy it is based on has a strong safety record. If Aviva aligns with BCBT, it should be well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for suicide prevention, which often involve in-person therapy sessions or medication, Aviva offers a unique digital therapeutic approach. Aviva delivers Brief Cognitive Behavioral Therapy (BCBT) via a digital app, allowing for flexible and accessible mental health support anytime, anywhere. Researchers are excited about Aviva because this digital delivery method can increase accessibility for individuals who may have barriers to traditional therapy, such as geographic location or scheduling constraints. By providing therapy through an app, Aviva has the potential to offer immediate support and intervention, which could be crucial in preventing suicidal behavior.

What evidence suggests that Aviva might be an effective treatment for suicide prevention?

Research has shown that Brief Cognitive Behavioral Therapy (BCBT), delivered through a digital platform like Aviva, can effectively reduce suicide attempts. In this trial, some participants will receive BCBT via the digital therapeutic app Aviva. One study found that people receiving BCBT had fewer suicide attempts compared to those in other types of therapy. Another source suggests that BCBT could prevent 23 to 25 more suicide attempts and 1 to 3 more deaths per 100 patients. Early trials of Aviva indicated it is safe and may be effective, with improvements enhancing its delivery. The digital format allows users to access therapy anytime, potentially increasing its accessibility and impact. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for Servicemembers with recent suicidal thoughts or attempts, who are seen in primary care clinics. They must have indicated a risk of suicide on specific assessments like the PHQ-9 and CSSRS Screener. Participants should be comfortable using smartphones but cannot join if they don't meet the clinic's criteria for suicide risk or can't follow the study procedures.

Inclusion Criteria

Suicidal ideation within the past week and/or a suicide attempt within the past 30 days

Ownership of either an Apple iPhone iOS 11 or higher or an Android smartphone OS 8.1 or higher

I can understand and agree to the study's consent form.

Exclusion Criteria

Experiencing active psychosis or mania requiring hospitalization

Inability to use a smartphone.

I am able to understand and consent to the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BCBT via the Aviva digital platform over 8 weeks

8 weeks

Weekly check-ins with research clinicians

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Assessments at 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Aviva

Trial Overview The trial tests Aviva, a digital version of Brief Cognitive Behavioral Therapy (BCBT), against standard safety planning and mental health care. Aviva aims to reduce suicidal ideation through an app over 8 weeks with features allowing revisiting treatment modules. Engagement with the app will also be analyzed for its impact on reducing suicidal thinking.

How Is the Trial Designed?

Group I: Digital Therapeutic Experimental Treatment 1 Intervention

BCBT Delivery via digital app

Group II: Treatment as Usual Active Control 1 Intervention

Aviva is already approved in United States for the following indications:

Approved in United States as Aviva for:

• Suicidal ideation
• Suicide prevention

Who Is Running the Clinical Trial?

University of Memphis

Lead Sponsor

Trials

73

Recruited

12,000+

Published Research Related to This Trial

A brief intervention and contact (BIC) program significantly reduced completed suicides among 680 suicide attempters, with an odds ratio of 35.4, indicating a strong protective effect.

The BIC program also lowered the rate of subsequent suicide attempts, with an odds ratio of 17.3, suggesting that this low-cost intervention could be an effective suicide prevention strategy in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention for suicide attempters: A randomized controlled study. Vijayakumar, L., Umamaheswari, C., Shujaath Ali, ZS., et al.[2021]

Brief cognitive behavioral therapy (BCBT) is projected to prevent 23 to 25 more suicide attempts and 1 to 3 more suicide deaths per 100 patients compared to standard treatment for suicidal US Army soldiers, indicating its efficacy in reducing suicide risk.

BCBT is estimated to save the Department of Defense between $15,000 to $16,630 per patient compared to usual treatment, suggesting it may be a cost-effective intervention for addressing suicide risk among active-duty soldiers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic Evaluation of Brief Cognitive Behavioral Therapy vs Treatment as Usual for Suicidal US Army Soldiers. Bernecker, SL., Zuromski, KL., Curry, JC., et al.[2022]

In a study of 484 patients receiving internet-delivered cognitive behavioral therapy (iCBT) for depression, suicidal ideation significantly decreased from 50% at baseline to 27% after treatment, indicating that iCBT can effectively reduce thoughts of suicide.

Major depression also showed a significant reduction, with prevalence dropping from 70% to 30%, suggesting that iCBT not only helps with suicidal thoughts but also improves overall depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behaviour therapy via the internet for depression: a useful strategy to reduce suicidal ideation. Mewton, L., Andrews, G.[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]

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]

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]

A digital mental health program providing internet-based cognitive behavioral therapy (iCBT) was successfully implemented in primary care, with 2,228 patients prescribed the program and nearly 49% enrolling, indicating good acceptance among patients.

Patients who engaged with the iCBT program showed significant clinical improvements, with a 23% reduction in depression scores (PHQ-9) and a 26% reduction in anxiety scores (GAD-7), demonstrating the efficacy of digital tools in treating mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing depression and behavioral health needs through a digital program at scale. Sharif-Sidi, Z., Shen, C., Wong, W., et al.[2021]

Self-guided internet-based cognitive behavioral therapy (iCBT) significantly reduces depressive symptoms compared to control groups, with a moderate effect size indicating its efficacy as a treatment option.

The study analyzed data from 3876 participants across 13 trials, showing that adherence to iCBT is linked to better treatment outcomes, suggesting that engagement with the program is crucial for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Self-guided Internet-Based Cognitive Behavioral Therapy in the Treatment of Depressive Symptoms: A Meta-analysis of Individual Participant Data. Karyotaki, E., Riper, H., Twisk, J., et al.[2022]

Internet-based cognitive behavioral therapy (iCBT) has been found to significantly reduce suicidal ideation among individuals, based on a review of four studies involving 1225 participants.

While iCBT shows promise in addressing suicidal thoughts, there is currently insufficient evidence to confirm its effectiveness in reducing actual suicide attempts or deaths, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based cognitive behavioral therapy for suicide: a systematic review and meta-analysis of RCTs. Yu, T., Hu, D., Teng, F., et al.[2022]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2826055

Telehealth Brief Cognitive Behavioral Therapy for Suicide ... The findings of this randomized clinical trial suggest that BCBT delivered via video telehealth is effective for reducing suicide attempts.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39531231/

Telehealth Brief Cognitive Behavioral Therapy for Suicide ... Participants randomized to BCBT made significantly fewer suicide attempts than participants randomized to PCT (mean [range], 0.70 [0.00-8.00] ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06318962

Study Details | NCT06318962 | Examining the Efficacy of a ... The primary aim of the project is to test the efficacy of BCBT delivered via a digital platform (i.e., smartphone) to Servicemembers with recent suicidal ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0005789425001145

Massed brief cognitive behavioral therapy (mBCBT) for ... Two (6.7%) mBCBT patients made a suicide attempt (1 actual attempt and 1 interrupted attempt) within 1 month of completing treatment; the actual ...

5. withpower.com withpower.com/trial/phase-suicide-suicidal-ideation-1-2024-f7940?condition=&query=AVAVA&overallStatus=Recruiting&hasNoPlacebo=false

Digital Therapy for Suicide Prevention Brief cognitive behavioral therapy (BCBT) is projected to prevent 23 to 25 more suicide attempts and 1 to 3 more suicide deaths per 100 patients compared to ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2837367

A Digital Therapeutic Intervention for Inpatients With ... Suicide-focused cognitive behavior therapies (CBTs) have been shown to reduce suicidal behaviors by approximately 20% on average compared with ...