Web-Based Intervention for Suicidal Thoughts

(REST-V Trial)

Overseen By Joseph W Boffa, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Active psychosis, Unmedicated bipolar, Substance use, others

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

Compensation: Varies

Number of Visits: 5

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based program called "Re-Evaluating Suicidal Thoughts," designed to help Veterans manage suicidal thoughts by teaching useful coping skills. Researchers aim to determine if this online tool can reduce suicidal thoughts and behaviors more effectively than regular health care visits alone. Veterans who have experienced suicidal thoughts in the past two weeks might be suitable candidates for this study. The goal is to make help for these thoughts more accessible for Veterans. As an unphased study, this trial provides Veterans with a unique opportunity to access innovative support tools that could significantly enhance their mental health.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude those with unmedicated bipolar disorder, which suggests that staying on certain medications might be necessary.

What prior data suggests that this web-based intervention is safe for Veterans?

Research has shown that online programs for managing suicidal thoughts are generally safe and well-received. These programs help reduce suicidal thoughts by teaching coping skills. One study found that internet-based cognitive behavioral therapy (iCBT) significantly reduced suicidal thoughts compared to not using the program.

Another review of digital programs found they can effectively reduce suicidal behaviors in adults. These programs often include stories from people who have successfully managed their suicidal thoughts, which can be comforting and motivating.

These studies have reported no major negative side effects, suggesting that online programs are a safe option for those dealing with suicidal thoughts. The trial is labeled "Not Applicable," indicating the treatment is considered safe enough to test without early-phase safety trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Web-Based Intervention for Suicidal Thoughts trial because it explores a new approach to addressing suicidal ideation through an online program called REST (Re-Evaluating Suicidal Thoughts). Unlike traditional treatments such as therapy sessions or medication, this web-based intervention offers a flexible and accessible way for veterans to manage their thoughts while continuing their standard care. By integrating technology, REST could potentially reach a larger audience and provide immediate support, which is crucial for individuals in crisis. The hope is that this method will enhance existing care and offer a more personalized and immediate resource for those struggling with suicidal thoughts.

What evidence suggests that this web-based intervention is effective for reducing suicidal thoughts?

Research has shown that teaching coping skills can help reduce suicidal thoughts. Methods like Cognitive Behavioral Therapy (CBT) and Dialectical Behavior Therapy (DBT) focus on these skills and have proven effective in preventing suicidal behavior. Programs that boost self-esteem also help reduce suicidal actions. One study found that short, focused interventions can decrease both suicidal thoughts and emotional distress. In this trial, the Re-Evaluating Suicidal Thoughts (REST) intervention, which teaches similar coping strategies, will be tested to determine its effectiveness in reducing suicidal thoughts among Veterans. Participants in this trial may receive the REST intervention alongside their standard health care, or they may continue with their standard health care alone. ^{1 6 7 8 9}

Who Is on the Research Team?

Joseph W Boffa, PhD

Principal Investigator

Southeast Louisiana Veterans Health Care System, New Orleans, LA

Are You a Good Fit for This Trial?

This trial is for Veterans aged 18 or older who have had suicidal thoughts in the past two weeks. It's not suitable for those with active psychosis, unmedicated bipolar disorder, or severe substance use disorders requiring detox before other treatments.

Inclusion Criteria

Veteran

Past two-week suicidal ideation as indicated by positive reply to C-SSRS questions ('Have you had any actual thoughts of killing yourself,' or, 'Have you been thinking about how you might do this?')

Exclusion Criteria

Instances in which a substance use disorder would indicate inpatient detoxification prior to engaging in other outpatient mental health interventions

Active psychosis

I have bipolar disorder and am not taking medication for it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants complete the REST intervention and baseline assessments

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in suicidal ideation and behaviors

1 month

4 visits (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Re-Evaluating Suicidal Thoughts

Trial Overview The study compares a web-based suicide prevention program teaching coping skills to ease emotional distress against standard healthcare visits. The goal is to see if this intervention better reduces suicidal thoughts and behaviors over one month.

How Is the Trial Designed?

Group I: TAU Experimental Treatment 1 Intervention

Veterans in this condition will be expected to engage in their standard course of heath care.

Group II: REST + TAU Experimental Treatment 1 Intervention

Veterans in this condition will complete the REST intervention and be expected to remain engaged in their standard course of health care as described in the TAU condition.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

The telehealth suicide safety planning intervention (SPI) was found to be highly acceptable and feasible among high-risk Veterans, with participants rating it positively on acceptability (M=17.50), appropriateness (M=17.25), and feasibility (M=18) on a scale of 1 to 20.

Participants reported enhanced suicidal disclosure and improved management of urges, indicating that the SPI effectively supported their mental health needs while also addressing barriers like privacy and technology issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Study of Telehealth Delivery of Suicide-Specific Group Treatment "Project Life Force". Patel, SR., Sullivan, SR., Mitchell, EL., et al.[2023]

An unguided online self-help intervention significantly reduced suicidal thoughts in 236 adults with mild to moderate suicidal ideation, particularly benefiting those with a history of repeated suicide attempts, with a small effect size of d=0.28.

The intervention also led to a notable reduction in worry (d=0.33), suggesting that while the overall effects were modest, the online format could effectively reach and support many individuals in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of online self-help for suicidal thoughts: results of a randomised controlled trial. van Spijker, BA., van Straten, A., Kerkhof, AJ.[2022]

An automated, self-guided Internet-based safety plan (IBSP) was developed and evaluated by 150 participants who reported suicidality, showing moderate perceived utility among users.

Participants generally believed the IBSP could be more helpful for others than for themselves, indicating a potential gap in personal recognition of its benefits, and males were less likely to complete the safety plan steps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived Utility of the Internet-Based Safety Plan in a Sample of Internet Users Screening Positive for Suicidality. Spangler, DA., Muñoz, RF., Chu, J., et al.[2022]

In a study of 299 primary care patients prescribed an internet cognitive behavior therapy (iCBT) course for depression, suicidal ideation decreased from 54% to 30% after treatment, indicating the effectiveness of iCBT in reducing suicidal thoughts.

The reduction in suicidal ideation occurred despite minimal clinician contact and without a specific focus on suicidal thoughts, suggesting that iCBT can be beneficial for patients with significant suicidal ideation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical audit of changes in suicide ideas with internet treatment for depression. Watts, S., Newby, JM., Mewton, L., et al.[2021]

A randomized controlled trial involving 724 participants in Belgium showed that a web-based intervention significantly reduced suicidal ideation, depression, hopelessness, worrying, and anxiety compared to a waitlist control group.

The online self-help intervention proved effective in addressing suicidal thoughts in individuals who faced barriers to traditional face-to-face treatment, although the study noted a high dropout rate in the intervention group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The online treatment of suicidal ideation: A randomised controlled trial of an unguided web-based intervention. De Jaegere, E., van Landschoot, R., van Heeringen, K., et al.[2020]

A study involving 459 participants found that while most individuals preferred face-to-face treatment for suicidal thoughts, those with higher levels of suicide ideation were more likely to prefer online help methods.

The findings suggest that the Internet could serve as an important alternative platform for delivering interventions to individuals at risk of suicide, especially for those who may avoid traditional treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide Ideation and Acceptability Toward Online Help-Seeking. Wilks, CR., Coyle, TN., Krek, M., et al.[2022]

The Virtual Hope Box (VHB) app was found to be more regularly used and preferred by high-risk patients and their clinicians compared to a traditional hope box, indicating its potential effectiveness in helping patients cope with negative thoughts and stress.

Patients reported that the VHB was beneficial, easy to set up, and expressed a strong likelihood of continued use and recommendation to others, suggesting its practicality as a therapeutic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Virtual Hope Box smartphone app as an accessory to therapy: proof-of-concept in a clinical sample of veterans. Bush, NE., Dobscha, SK., Crumpton, R., et al.[2022]

A study involving 155 callers to a helpline found that participants experienced significant reductions in suicidal ideation over 12 months, regardless of whether they received web-based Cognitive Behaviour Therapy (CBT) or other forms of support.

Improvements in depression levels were linked to reductions in suicidal thoughts, suggesting that addressing depression may be crucial in managing suicide ideation, and highlighting the need for further research on targeted interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a web-based depression intervention on suicide ideation: secondary outcome from a randomised controlled trial in a helpline. Christensen, H., Farrer, L., Batterham, PJ., et al.[2022]

The online self-help intervention 'Living with Deadly Thoughts' showed significant reductions in suicidal thinking severity over time, but it was not more effective than the control program 'Living Well' in a study involving 418 suicidal adults.

The study faced limitations such as being underpowered, high dropout rates, and challenges in verifying self-reported suicide attempts, indicating a need for further research to explore the conditions under which the intervention may be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Web-Based Self-Help Program for Suicidal Thinking in an Australian Community Sample: Randomized Controlled Trial. van Spijker, BA., Werner-Seidler, A., Batterham, PJ., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05884476

Randomized Clinical Trial of Re-Evaluating Suicidal ... Suicide prevention interventions may therefore be more effective if they provision adaptive skills for coping with the psychological burden of suicidal ideation ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9092896/

Improving Suicide Prevention Through Evidenced-Based ... CBT and DBT prevent suicidal behavior. Active screening for suicidal ideation or behavior is not proven to be better than just screening for depression.

3. sciencedirect.com sciencedirect.com/science/article/pii/S016517812400088X

The effectiveness of a suicide prevention program in ... A primary care suicide prevention program supported by community public health resources, was effective in reducing suicide rates.

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.925423/full

The Effectiveness of Self-Esteem-Related Interventions in ... The current systematic review and meta-analysis aimed to investigate the effectiveness of self-esteem-related interventions on suicidal behaviors.

5. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.focus.20220083

Brief and Ultra-Brief Suicide-Specific Interventions | Focus In adult populations, CAMS has demonstrated effectiveness in reducing suicidal ideation and overall symptom distress, compared with treatment as ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11283240/

A Scoping Review of Digital-Based Intervention for ... This study aims to describe a digital intervention to reduce the risk of suicidal behavior in adults. The design used in this study was a scoping review.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10877489/

Effectiveness of Online and Remote Interventions ... This study aimed to give an overview of randomized controlled studies examining remote or online interventions for mental health in children, adolescents, and ...

8. sciencedirect.com sciencedirect.com/org/science/article/pii/S143888711900219X

Development and Evaluation of a Web-Based Resource for ... Central to the educative website are first-person stories of successful coping with and recovery from suicidal thoughts and painful emotions ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2765056

Internet-Based Cognitive Behavioral Therapy to Reduce ... These results show that iCBT interventions are associated with significant reductions in suicidal ideation compared with control conditions.