PRECISE for Suicide Prevention

Overseen By Kevin S Kuehn, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Substance use disorder, Dementia, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a personalized treatment called PRECISE for individuals at high risk of suicide. The goal is to determine if tailoring interventions to individuals' unique needs can more effectively reduce suicidal thoughts. Participants will receive either high or low-intensity personalized care, with ongoing assessments to adapt the treatment. Suitable candidates are adults who have recently experienced suicidal thoughts or attempts and are willing to share contact information for safety planning. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to more effective suicide prevention strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that safety planning interventions, part of the PRECISE treatment, effectively reduce thoughts and behaviors related to suicide. Some studies reported a 42% drop in suicide events with these interventions compared to standard care. This suggests the approach is both helpful and safe for individuals at high risk of suicide.

PRECISE also incorporates techniques from Dialectical Behavior Therapy (DBT), a well-known and generally accepted treatment for managing emotions. While no specific negative effects have been reported for PRECISE, using proven methods like safety planning and DBT techniques enhances its safety. Overall, existing research supports the safety of PRECISE's elements for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PRECISE approach for suicide prevention because it offers a tailored, dynamic method of intervention. Unlike traditional treatments that often follow a one-size-fits-all protocol, PRECISE uses personalized idiographic models to adapt the treatment plan based on each session's outcomes. This iterative process allows for a more responsive and patient-centered strategy, potentially enhancing the effectiveness of suicide prevention efforts. Additionally, the high-intensity arm involves comprehensive engagement over eight weeks, while the low-intensity arm provides a focused initial burst of support, both aiming to optimize treatment based on individual needs. This adaptability and personalization are what make PRECISE stand out from existing options.

What evidence suggests that this trial's treatments could be effective for suicide prevention?

Research has shown that personalized approaches, such as PRECISE, can enhance efforts to prevent suicide. Studies indicate that tailoring treatments to individual needs effectively lowers suicide rates. Comprehensive methods with multiple components have succeeded in various settings. In this trial, participants will join either a high-intensity or low-intensity arm of the PRECISE method. PRECISE uses data to customize safety plans and specific skills training, both proven to reduce suicidal thoughts. By focusing on personal triggers and emotions, PRECISE aims to help individuals manage their emotions better, leading to less distress and fewer thoughts of suicide. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults at high risk of suicide who may benefit from a personalized intervention. Participants should be experiencing suicidal thoughts or depression and are willing to engage in an intensive study involving regular self-assessments and coaching sessions.

Inclusion Criteria

English fluency

Endorsement of active suicidal ideation on the Columbia Suicide Severity Rating Scale (>2 or past month thoughts of killing self or attempt in past month)

Willingness to provide contact information for a key information to be contacted as part of our risk and safety plan.

Exclusion Criteria

Past year exposure to DBT

Moderate/severe substance use disorder within the past thirty days

Dementia, mild cognitive impairment and/or traumatic brain injury

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive personalized suicide prevention interventions using ecological momentary assessment and idiographic models

8 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Assessments at 8 and 16 weeks post-enrollment

Long-term follow-up

Participants are assessed for long-term outcomes and changes in suicidal ideation and emotion regulation

6 months

What Are the Treatments Tested in This Trial?

Interventions

• PRECISE

Trial Overview

PRECISE, a novel treatment, is being tested. It uses data from frequent personal assessments to tailor suicide prevention strategies for each individual. The trial compares two versions: one with initial assessment-based tailoring and another with ongoing, more intense customization over eight weeks.

How Is the Trial Designed?

Group I: Low-Intensity Experimental Treatment 1 Intervention

In the low intensity arm, participants will complete only an initial two weeks burst of EMA and GIMME will be run following an initial burst. A treatment plan for the next eight weeks will be generated based on the output.

Group II: High-Intensity Experimental Treatment 1 Intervention

In the high intensity arm, participants will complete all eight weeks of EMA with idiographic models generated between each session. Coaches then shape selection of skills in collaboration with the patient and a treatment plan for the next session will be generated.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

A pharmacovigilance analysis of over 85,000 cases from the FDA's Adverse Event Reporting System identified specific drug combinations and indications that may increase the risk of suicide, highlighting the complexity of suicide risk factors.

The study suggests that certain demographic groups may be more affected by these drug combinations, indicating a need for further research to validate these findings and improve suicide prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mining Drugs and Indications for Suicide-Related Adverse Events. Ding, T., Chen, ES.[2020]

In the ED-SAFE study, structured telephone follow-up assessments were crucial for identifying adverse events (AEs), detecting 45% of total AEs that were missed by chart reviews alone.

The detection of suicide attempts varied significantly by method, with structured follow-ups identifying 59% of attempts compared to only 18% through chart reviews, highlighting the importance of using multiple detection methods in suicide research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using structured telephone follow-up assessments to improve suicide-related adverse event detection. Arias, SA., Zhang, Z., Hillerns, C., et al.[2021]

The study presents a consensus framework for assessing the risk of treatment-related suicidal ideation and behavior (SIB) during drug development, addressing a growing concern among health authorities.

This framework considers various factors, including the chemical and pharmacological properties of drugs, patient populations, and regulatory precedents, to better identify and manage SIB risks in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated risk assessment of suicidal ideation and behavior in drug development. Muller, PY., Dambach, D., Gemzik, B., et al.[2022]

The study analyzed adverse events related to suicidality in 9 randomized placebo-controlled trials of duloxetine, revealing that while suicides were clearly identifiable, suicidal ideation and preparatory behaviors were often obscured due to the limitations of the medical coding dictionaries used, particularly COSTART.

The findings suggest that adverse event data in clinical study reports may not fully represent patient experiences, highlighting the importance of using detailed narratives and individual patient listings to capture a more accurate picture of potential harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study. Maund, E., Tendal, B., Hróbjartsson, A., et al.[2023]

Emphasizing early intervention and ongoing low-intensity contact with individuals at risk of suicide can be more effective than solely focusing on those deemed 'highest risk', suggesting a shift in treatment strategy.

The use of advanced interactive computer programs can enhance screening and training for healthcare providers, improving access to mental health services and continuity of care for suicidal individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide prevention in a treatment setting. Litman, RE.[2022]

In a study of 104 psychiatric inpatients, those receiving the Collaborative Assessment and Management of Suicidality (CAMS) intervention showed significantly greater improvements in depression, suicidal ideation, and overall well-being compared to those receiving standard treatment.

While all patients improved during their stay, the benefits of CAMS were not maintained at the 6-month follow-up, indicating that ongoing support may be necessary to sustain the advantages of specialized interventions for suicidal patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled comparison trial of the Collaborative Assessment and Management of Suicidality (CAMS) in an inpatient setting: Outcomes at discharge and six-month follow-up. Ellis, TE., Rufino, KA., Allen, JG.[2019]

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 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]

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