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

Trial Summary

What is the purpose of this trial?

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 ideation and/or suicide attempts presenting to primary care clinics. Given existing challenges of scaling empirically-supported treatments/interventions for suicidality with fidelity, this project could lead to markedly expanded access to BCBT, along with improving our understanding about what intervention strategies are most effective and how they can be delivered with meaningful fidelity. Aviva, the digital version of BCBT, was developed for use with patients across the full spectrum of healthcare settings, including primary care. Aviva is not an emergency alert system, rather a digital platform for delivery of the full scope of BCBT treatment components. An open-label single group Phase I clinical trial has demonstrated the safety, tolerability, feasibility, fidelity, and potential efficacy of Aviva, with participants completing modules over 8 weeks, and follow-up assessments at weeks 1, 4, and 8. Subsequent refinements included the addition of technical features that would allow patients to revisit and/or repeat previously completed modules, along with integration of more characters for delivering video vignettes and greater opportunities for skills practice and treatment engagement. These modifications have further enhanced Aviva safety, tolerability, and fidelity, consistent with the original BCBT protocol. Not only is it hypothesized that Aviva will result in significantly larger reductions in severity of suicidal ideation than participants randomized to the control condition, but also that greater app engagement will be negatively correlated with severity of suicidal thinking. Moderators and mediators (i.e. suicidal beliefs, wish to live, impulsive decision-making) of intervention effects will also be examined. The study will be conducted at the primary care clinics at Fort Carson, with a goal of enrolling 720 patients across a two-year timeframe. Participants will be identified using each clinic's existing suicide risk assessment methods, including the PHQ-9 suicide risk item and a score of 1 or higher on the CSSRS Screener (Recent). Participants will be randomly assigned to one of two treatment conditions, Aviva or control (i.e., development of a safety plan consistent with local procedures and policies, along with referral for standard mental health care and suicide risk management in accordance with local policies and procedures). In an effort to address potential performance bias specific to smartphone use, participants in the control condition will download the Suicide Safety Plan app to their smartphones. Those in the Aviva condition will also complete weekly check-ins with Project 2 research clinicians to review treatment adherence, identify and respond to any logistical/operational problems, and respond to any unexpected emergencies and/or participant safety concerns. Participants will have up to five data points: baseline, 3, 6, 9, and 12 months. All data available from all participants and all time points will be included in the analyses, consistent with the intent-to-treat principle. Across our two previous clinical trials and our in-progress RCT, attrition during the first 12 months postbaseline was \<30% and we anticipate similar rates in this trial.

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 data supports the effectiveness of the treatment Aviva, Digital BCBT, Brief Cognitive Behavioral Therapy for Suicide Prevention?

Research shows that Brief Cognitive Behavioral Therapy (BCBT) is effective in reducing suicide attempts among US Army soldiers. Additionally, internet-based cognitive behavioral therapy (iCBT) has been found to reduce suicidal thoughts, which suggests that digital versions of cognitive behavioral therapy can be beneficial for suicide prevention. ^{1 2 3 4 5}

Is digital therapy for suicide prevention safe for humans?

Research on internet-based cognitive behavioral therapy (iCBT) suggests it is generally safe and can help reduce suicidal thoughts, although more studies are needed to confirm its safety specifically for preventing suicide attempts. ^{1 3 4 6 7}

How is the treatment Aviva for suicide prevention different from other treatments?

Aviva is unique because it combines digital tools with brief cognitive behavioral therapy (BCBT) to help prevent suicide, offering a potentially more accessible and resource-efficient option compared to traditional face-to-face therapy. ^{1 5 6 8 9}

Eligibility Criteria

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

I am 18 years old or older.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Economic Evaluation of Brief Cognitive Behavioral Therapy vs Treatment as Usual for Suicidal US Army Soldiers. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Intervention for suicide attempters: A randomized controlled study. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive behaviour therapy via the internet for depression: a useful strategy to reduce suicidal ideation. [2018]

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

Effectiveness of internet-based cognitive behavioral therapy for suicide: a systematic review and meta-analysis of RCTs. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Addressing depression and behavioral health needs through a digital program at scale. [2021]

6. 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]

7. United States 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. [2022]

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

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

9. England pubmed.ncbi.nlm.nih.gov

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