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

Trial Summary

What is the purpose of this trial?

This trial tests WellPATH-PREVENT, a tablet-based program, to help adults aged 50-90 manage emotions and reduce suicide risk. The program teaches recognizing emotional triggers and changing negative thoughts into positive ones.

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 data supports the effectiveness of the treatment Optimized WellPATH-PREVENT, WellPATH, WellPATH-PREVENT, Cognitive Reappraisal Intervention for Suicide Prevention (CRISP), WellPATH-PREVENT, WellPATH, Cognitive Reappraisal Intervention for Suicide Prevention (CRISP)?

Research shows that the WellPATH app, part of the CRISP treatment, is feasible and acceptable for helping suicidal patients manage their emotions outside of therapy. Additionally, the Safety Planning Intervention (SPI), which shares similar goals of reducing suicidal thoughts and behaviors, has been shown to improve outcomes like reducing depression and hospitalizations. ^{1 2 3 4 5}

Is the mobile intervention for suicidal thoughts safe for humans?

The WellPATH app, part of the CRISP intervention, has been tested for feasibility and acceptability in middle-aged and older adults at high suicide risk, suggesting it is generally safe for use in humans. ^{1 3 4 6 7}

What makes the WellPATH-PREVENT treatment unique for preventing suicidal thoughts?

WellPATH-PREVENT is unique because it uses a mobile app to help people manage their emotions and thoughts outside of therapy sessions, making it more accessible and personalized. This digital approach allows for real-time support and intervention, which can be crucial for individuals at high risk of suicide. ^{1 8 9 10 11}

Research Team

Dimitris Kiosses, PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

Aphasia, sensory problems, and/or inability to speak English

I have been diagnosed with a psychotic disorder.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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]

References

1. England 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. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Successful Treatment of Suicidal Risk. [2022]

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

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. [2022]

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

Developing Adaptive Treatment Strategies to Address Suicidal Risk in College Students: A Pilot Sequential, Multiple Assignment, Randomized Trial (SMART). [2023]

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

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

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

Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) for Middle-Aged and Older Adults Hospitalized for Suicidality. [2022]

7. United States 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. [2019]

8. England 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. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Mobile Health Technology Interventions for Suicide Prevention: Systematic Review. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

SERO - A New Mobile App for Suicide Prevention. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Smartphone-based safety plan for suicidal crisis: The SmartCrisis 2.0 pilot study. [2023]