Mobile Intervention for Suicidal Thoughts

Recruiting at 1 trial location

Overseen By Laurie Evans, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Psychotic disorders, Dementia, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 9

115 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called WellPATH-PREVENT to determine if it can help middle-aged and older adults manage emotions better and reduce suicide risk. Participants recently hospitalized for suicidal thoughts or attempts will use this app, which aims to teach cognitive reappraisal—a skill to change thinking about emotional situations. The study includes a control group receiving usual care for comparison. It suits individuals aged 50-90 who have recently been hospitalized for suicidal thoughts or attempts, but it excludes those with conditions like psychosis or dementia. As an unphased trial, this study offers a unique opportunity to contribute to innovative mental health solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does include patients who are on psychotropic medications and receiving community psychotherapy.

What prior data suggests that the WellPATH-PREVENT intervention is safe for middle-aged and older adults?

Previous studies have shown that WellPATH-PREVENT can reduce suicide risk in adults. This mobile app helps users change their thinking about difficult situations. Research has shown that similar programs have been well-received by participants, with no major reports of negative effects. This suggests that using the WellPATH-PREVENT app is generally safe for most participants. Those considering joining may find this information reassuring regarding its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the WellPATH-PREVENT treatments because they represent a new approach to managing suicidal thoughts using mobile technology. Unlike traditional methods that often rely on medication or in-person therapy, WellPATH-PREVENT is delivered via a mobile platform, allowing for continuous support and intervention. The Optimized WellPATH-PREVENT version enhances this by refining the intervention based on user feedback and data, potentially increasing its effectiveness. This accessibility and adaptability could make it a game-changer in providing timely help for those struggling with suicidal thoughts, fitting seamlessly into their daily lives.

What evidence suggests that WellPATH-PREVENT is effective for reducing suicide risk?

Research has shown that the WellPATH-PREVENT mobile app, one of the treatments studied in this trial, may help lower the risk of suicide by improving emotion management. It uses a method called cognitive reappraisal, which involves changing thoughts about situations to improve feelings. Studies have found that this approach can help people control their emotions more effectively, which is crucial for those at high risk of suicide. Specifically, users of WellPATH-PREVENT demonstrated better emotion management, a key factor in reducing suicidal thoughts. The app allows users to practice these techniques outside regular therapy sessions, providing support when needed most. ^{1 5 6 7 8}

Who Is on the Research Team?

Dimitris Kiosses, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for middle-aged and older adults aged 50-90 who have been hospitalized due to suicidal thoughts or attempts. Participants must be able to understand English, not suffer from severe cognitive impairments (MMSE > 24), psychotic disorders, dementia, or acute medical illnesses.

Inclusion Criteria

Patients on psychotropics and on after-care community psychotherapy

Recent hospitalization for suicidal ideation or suicide attempt with Columbia Suicide Severity Rating Scale (CSSR-S) ≥ 2, 'Non-specific Active Suicidal Thoughts'

Diagnosis based on a modified SCID-5 Clinical Trials Version to assess DSM-5 diagnoses, excluding current diagnosis of Psychotic Disorder and diagnosis of Dementia

Exclusion Criteria

I have been diagnosed with a psychotic disorder.

I have not had a severe illness or major surgery in the last 3 months.

I have been diagnosed with dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

R61 Treatment

Participants receive WellPATH-PREVENT intervention for 12 weeks, including training on cognitive reappraisal techniques and use of a tablet

12 weeks

4 assessments (in-person): Study entry, discharge, Week 6, Week 12

R33 Treatment

Participants are randomized to an optimized version of WellPATH-PREVENT or Attention Control-Usual Care, with assessments at multiple time points

24 weeks

5 assessments (in-person): Study entry, discharge, Week 6, Week 12, Week 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Optimized WellPATH-PREVENT
• WellPATH-PREVENT

Trial Overview The study tests WellPATH-PREVENT, a mobile psychosocial intervention aimed at improving emotion regulation and reducing suicide risk in participants recently discharged after hospitalization for suicide-related issues.

How Is the Trial Designed?

Group I: Proof-of-Concept WellPATH-PREVENT (R61) Experimental Treatment 1 Intervention

Group II: Optimized WellPATH-PREVENT (R33) Experimental Treatment 1 Intervention

Group III: Attention Control Usual Care (R33) Active Control 1 Intervention

The AC-UC group will parallel the delivery of the WellPATH-PREVENT intervention and will also include: a) meetings during hospitalization: a non-clinical member of the team will present the control tablet and explain its use; b) scheduled or requested meetings through zoom: to parallel the delivery of WellPATH-PREVENT. The tablet will still have a link to schedule a meeting with a non-clinician member of the team. The meetings will focus on issues that the patient may have in using the tablet. There will not be any therapeutic or psychological interaction between participants in the control group and the team. The experimental and the control group will also be under usual outpatient care, which is arranged during the hospitalization by the inpatient treatment team.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The study analyzed responses from 49 patients regarding helpful aspects of their treatment for suicidal risk, leading to the development of a reliable coding system to identify major themes in their experiences.

Insights gained from 52 patients on what they learned from their clinical care can inform future suicide-specific treatments, highlighting the importance of patient feedback in improving therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Treatment of Suicidal Risk. Schembari, BC., Jobes, DA., Horgan, RJ.[2022]

The pilot phase of the SmartCrisis 2.0 trial demonstrated that a smartphone-based safety plan for patients with recent suicidal behavior is feasible and well-accepted, with a participation rate of 77% and high satisfaction ratings (overall satisfaction score of 9.6 out of 10).

Patients found the safety plan useful (7.4/10) and easy to use (8.9/10), with common coping strategies including walking and exercise, indicating that the app could be a valuable tool in clinical practice for supporting mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based safety plan for suicidal crisis: The SmartCrisis 2.0 pilot study. Porras-Segovia, A., De Granda-Beltrán, AM., Gallardo, C., et al.[2023]

The Safety Planning Intervention (SPI) is effective in reducing suicidal ideation and behavior, as well as improving depression and treatment engagement among adults experiencing suicide-related distress, based on a systematic review of 26 studies.

The SPI is adaptable and can be delivered in various formats (in-person or online) and as a standalone or combined intervention, making it a flexible tool in suicide prevention practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. Ferguson, M., Rhodes, K., Loughhead, M., et al.[2022]

The pilot study involving 62 college students at risk of suicide demonstrated that an adaptive treatment strategy, using a Sequential Multiple Assignment Randomized Trial (SMART) design, is feasible and acceptable for this population.

Participants reported high satisfaction with the treatment, and counselors effectively delivered the suicide-focused interventions, indicating that this approach could be a promising method for addressing suicidal risk among college students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing Adaptive Treatment Strategies to Address Suicidal Risk in College Students: A Pilot Sequential, Multiple Assignment, Randomized Trial (SMART). Pistorello, J., Jobes, DA., Compton, SN., et al.[2023]

Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) is a new psychosocial intervention designed specifically for middle-aged and older adults recently hospitalized for suicidal ideation or attempts, addressing the high suicide risk during the critical post-hospitalization period.

CRISP focuses on identifying personalized emotional triggers and using cognitive reappraisal techniques to help individuals manage negative emotions, potentially reducing suicidal thoughts and improving overall suicide prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) for Middle-Aged and Older Adults Hospitalized for Suicidality. Kiosses, DN., Alexopoulos, GS., Hajcak, G., et al.[2022]

A review of 20 randomized clinical trials found that certain psychosocial interventions and one pharmacotherapy were effective in reducing suicide attempts compared to standard treatments or placebo.

The effectiveness of psychosocial interventions was notably higher when targeting high-risk suicidal individuals, suggesting that these treatments are most beneficial for those with greater immediate risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral treatments of suicidal behaviors. Definitional obfuscation and treatment outcomes. Linehan, MM.[2022]

In a randomized controlled trial with 148 U.S. Army Soldiers, the Collaborative Assessment and Management of Suicidality (CAMS) was found to significantly reduce suicidal ideation (SI) compared to enhanced care as usual (E-CAU) by 3 months, with a strong effect size (Cohen's d = 0.93).

Both CAMS and E-CAU led to improvements in various behavioral health outcomes, but CAMS showed a notable advantage in reducing suicidal thoughts, highlighting its potential as an effective intervention for Soldiers with significant suicidal ideation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of the Collaborative Assessment and Management of Suicidality versus Enhanced Care as Usual With Suicidal Soldiers. Jobes, DA., Comtois, KA., Gutierrez, PM., et al.[2019]

Digital interventions, such as apps, showed a reduction in suicidal ideation scores among 3,356 participants across 14 studies, suggesting they may be more effective than simply waiting for treatment.

However, there was no evidence that these interventions reduced self-harm or suicide attempts, and many studies had design biases, indicating that more research is needed to confirm their safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of online and mobile telephone applications ('apps') for the self-management of suicidal ideation and self-harm: a systematic review and meta-analysis. Witt, K., Spittal, MJ., Carter, G., et al.[2022]

A review of 7 studies on mobile health (mHealth) apps for suicide prevention showed some positive effects, such as reduced depression and increased coping self-efficacy, but none significantly decreased suicidal ideation compared to control groups.

The review highlights the need for more rigorous research and standardized outcome measures in evaluating mHealth interventions, as current studies exhibit methodological limitations that affect their generalizability and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Technology Interventions for Suicide Prevention: Systematic Review. Melia, R., Francis, K., Hickey, E., et al.[2022]

The mobile app developed as part of the SERO suicide prevention program aims to reduce suicides and suicide attempts by enhancing self-management for individuals at risk, incorporating strategies like safety planning and mood tracking.

The app's design was informed by collaboration among health professionals, individuals at risk, and their families, ensuring it addresses real needs and integrates essential suicide prevention strategies effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SERO - A New Mobile App for Suicide Prevention. Meier, L., Gurtner, C., Nuessli, S., et al.[2022]

The WellPATH app, used during a 12-week psychotherapy intervention for middle-aged and older adults after suicide-related hospitalization, showed high feasibility and acceptability, with participants and therapists expressing satisfaction with the app.

Case studies indicated that using WellPATH helped patients reduce negative emotions and improve their ability to regulate emotions, suggesting potential benefits for suicide prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Emotion Regulation Tablet App for Middle-Aged and Older Adults at High Suicide Risk: Feasibility, Acceptability, and Two Case Studies. Kiosses, DN., Monkovic, J., Stern, A., et al.[2022]

Citations

1. trial.medpath.com trial.medpath.com/clinical-trial/311484973e573bfa/nct05183230-wellpath-prevent-mobile-intervention

WellPATH-PREVENT: A Mobile Intervention for Middle-Aged ... The goal of this project is to test whether WellPATH-PREVENT (a novel, mobile psychosocial intervention) improves a specific aspect of emotion regulation, ...

2. researchgate.net researchgate.net/publication/354452947_An_Emotion_Regulation_Tablet_App_for_Middle-Aged_and_Older_Adults_at_High_Suicide_Risk_Feasibility_Acceptability_and_Two_Case_Studies

An Emotion Regulation Tablet App for Middle-Aged and ... In this article, we present feasibility and acceptability data as well as two case studies demonstrating the use of WellPATH, a tablet app that ...

3. peearz.com peearz.com/trialsindex?nctid=NCT05183230

A Mobile Intervention for Middle-Aged and Older Adults ... The goal of this project is to test whether WellPATH-PREVENT (a novel, mobile psychosocial intervention) improves a specific aspect of emotion regulation, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5860974/

Cognitive Reappraisal Intervention for Suicide Prevention ... WellPATH adds to CRISP's clinical utility by helping the patient use the CRISP techniques outside of the office when the patient needs or wants to reduce ...

5. nimh.nih.gov nimh.nih.gov/health/trials/suicide-prevention

Suicide Prevention - National Institute of Mental Health (NIMH) The study will adapt and collect preliminary effectiveness data on a digital suicide prevention intervention that can be delivered in pediatric primary care ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03026127

A Novel Cognitive Reappraisal Intervention for Suicide ... The goal of this trial is to refine and test a novel emotion-regulation based psychosocial intervention designed to reduce suicide risk in middle-aged and ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1064748117305444

Cognitive Reappraisal Intervention for Suicide Prevention ... So, cognitive reappraisal intervention for suicide prevention (CRISP) that targets cognitive reappraisal may be useful to decrease suicidal risk (Kiosses et al.

8. reporter.nih.gov reporter.nih.gov/search/15EEC10D4C8DC5D37598B8961CAA4A01A2FFCEB861BF/project-details/10950388

A Mobile Intervention for Suicide Prevention For Middle ... ABSTRACT The goal of this project is to refine and test WellPATH-PREVENT, a novel, mobile, principally stand-alone psychosocial intervention designed to ...