Development of PRECISE: A Data Driven Personalized Suicide Prevention Intervention

Individuals at high-risk of suicide vary substantially from one another. Over time, risk factors for suicide may change within the same individual. Despite these differences, most treatments for suicidal thoughts assume that the same intervention works equally well for all individuals at high-risk of suicide. Intensive longitudinal data combined with network science, integrated with coaching, could be used to personalize suicide prevention interventions to make them more effective and efficient. This K23 Career Development application involves refining and testing a novel personalized treatment for individuals at high-risk called PeRsonalizEd Clinical Intervention for Suicidal Events or PRECISE. PRECISE leverages idiographic statistical techniques adopted from network science applied to ecological momentary assessment data to inform the tailoring of Safety Planning and skills from Dialectical Behavior Therapy, two existing evidence-based treatments for suicide. In Aim 1, a user-centered design approach will be used to refine PRECISE. Following the refinement of the intervention, informed by data from a case series in Aim 1, the investigators will then conduct a randomized controlled trial comparing two different intensities of personalization. In the low-intensity arm, the 8-week treatment will be tailored based on an initial two-week burst of ecological momentary assessment and one idiographic model. In the high-intensity arm, participants complete eight weeks of ecological momentary assessment and idiographic models are generated between each session. Coaches use the idiographic models to identify an individuals' drivers of suicidal thoughts and conduct behavioral chain analyses to tailor specific skills to then teach, shape, and reinforce in their individual clients. Assessments are completed pre-treatment, 8-weeks post-enrollment, and 16-weeks enrollment. The investigators hypothesize that both arms will demonstrate clinically significant reductions in suicidal ideation, but the high-intensity arm will be superior to the low-intensity arm in reducing ideation. Furthermore, the investigators anticipate that increases in effective emotion regulation skills and reductions in negative affect will account for the decrease in suicidal ideation. As individuals learn more effective emotion regulation strategies, they will experience less distress and thereby lower levels of suicidal ideation. This project is responsive to Objective 3.2 of the NIMH Strategic Plan and is integrated with a mentored research training plan focused on 1) suicide specific rigorous clinical trials, 2) user centered design in digital health, and 3) applications of network science to intensive longitudinal data. The project and training goal will support the Candidate's overarching goal to become a clinician-scientist engaged in independent research on personalized, impactful, rapid acting suicide prevention interventions for at risk adults.

Study Overview

• Status: Recruiting
• Conditions: Suicidal Thoughts and Behaviors
• Intervention / Treatment: Behavioral: PRECISE

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kevin S Kuehn, Ph.D.; Phone Number: (619) 543-5221; Email: kskuehn@health.ucsd.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • Recruiting
      • 8980 Villa La Jolla Drive
      • Contact: Kevin S Kuehn, Ph.D.; Phone Number: (619) 543-5221; Email: kskuehn@health.ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-65 years old
• 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)
• English fluency
• 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
• Lack of capacity to consent to research and/or under conservatorship.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-Intensity; 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.	Behavioral: PRECISE; PRECISE includes aspects of several evidence-based approaches, such as Safety Planning and DBT to manage and reduce suicide risk. During the initial visit, staff train participants how to complete EMAs. Participants then complete two weeks of five-times per day EMAs regarding their emotions, emotion regulation strategies as well as SITBs. Following an initial "learning period", participant data is analyzed via GIMME to determine the within-person correlates of SITBs. Data is processed through a real-time pre-programmed data cleaning and analysis script. Coaches then teach a selection of skills in collaboration with the client.
Experimental: Low-Intensity; 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.	Behavioral: PRECISE; PRECISE includes aspects of several evidence-based approaches, such as Safety Planning and DBT to manage and reduce suicide risk. During the initial visit, staff train participants how to complete EMAs. Participants then complete two weeks of five-times per day EMAs regarding their emotions, emotion regulation strategies as well as SITBs. Following an initial "learning period", participant data is analyzed via GIMME to determine the within-person correlates of SITBs. Data is processed through a real-time pre-programmed data cleaning and analysis script. Coaches then teach a selection of skills in collaboration with the client.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scale for Suicide Ideation	The Beck Scale for Suicide Ideation (SSI) is a 21-item self-report scale that measure the intensity of suicidal thoughts. The MSSI ranges from 0 [min] to 63 [max] with higher scores suggesting more severe suicidal ideation.	From enrollment to the end of the follow-up assessment at 6-months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotion Reactivity Scale	The ERS is a 21-item self-report measure developed to measure an individuals' emotion reactivity. The ERS ranges from 0 [min] to 84 [max] with higher scores suggesting more emotional intensity.	From enrollment to the end of the follow-up assessment at 6-months.
Cognitive Emotion Regulation Questionnaire	The Cognitive Emotion Regulation Questionnaire (CERQ) is a 36-item, self-report, multidimensional questionnaire constructed in order to identify the cognitive emotion regulation strategies (or cognitive coping strategies) someone uses after having experienced negative events or situations. Participants rate the 36 items using a 5-point Likert style scale (1 = Almost Never; 2 = Sometimes; 3 = Frequently; 4 = Often; 5 = Almost Always). There are 9 sub scales of the CERQ; 1) self-blame 2) acceptance; 3) rumination; 4) positive refocusing; 5) refocus planning; 6) positive reappraisal; 7) putting things into perspective; 8) catastrophizing; and 9) blaming others. Sub scales are calculated by summing across the items and dividing by the number of items within each sub scale (4). Higher scores indicate more frequent use of the strategy.	From enrollment to the end of the follow-up assessment at 6-months.

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: January 24, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: cognitive behavior therapy; coping; technology; emotion regulation; ecological momentary assessment; coping skills; coaching; dialectical behavior therapy; personalized feedback; personalized interventions; intensive longitudinal data
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Social Behavior; Self-Control; Suicidal Ideation; Behavior; Emotional Regulation
• Other Study ID Numbers: 811796

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study data manager will ensure all data is uploaded to the NIMH National Data Archive in accordance with existing guidelines and upload timelines (also see Resource Sharing). Anonymous data may also be uploaded to public repositories (e.g., Open Science Framework, Github) to facilitate data sharing with other researchers and ensure accuracy in reporting results.
• IPD Sharing Time Frame: Data will be uploaded to the Open Science Framework by 03/31/2030 and will be shared indefinitely.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No