Development of PRECISE: a Data Driven Personalized Suicide Prevention Intervention

Not Applicable

Not yet recruiting

• Conditions: Suicidal Thoughts and Behaviors

• Registration Number: NCT06809348
• Lead Sponsor: University of California, San Diego

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-01-29
• Last Update Submitted: 2025-01-29
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Study Start: 2025-09-01
• Primary Completion: 2030-03
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Scale for Suicide Ideation	From enrollment to the end of the follow-up assessment at 6-months.	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.

Secondary Outcome Measures

Name	Time	Method
Emotion Reactivity Scale	From enrollment to the end of the follow-up assessment at 6-months.	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.
Cognitive Emotion Regulation Questionnaire	From enrollment to the end of the follow-up assessment at 6-months.	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.

Trial Locations

Locations (1)

8980 Villa La Jolla Drive; 🇺🇸 San Diego, California, United States