Clinical trial NCT06809348: Development of PRECISE: a Data Driven Personalized Suicide Prevention Intervention
Official title: Development of PRECISE: a Data Driven Personalized Suicide Prevention Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicidal Thoughts and Behaviors
Keywords: personalized interventions
intensive longitudinal data
emotion regulation
coping
coping skills
dialectical behavior therapy
cognitive behavior therapy
ecological momentary assessment
personalized feedback
technology
coaching
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Scale for Suicide Ideation
timeFrame: From enrollment to the end of the follow-up assessment at 6-months.
Secondary outcomes:
measure: Emotion Reactivity Scale
timeFrame: From enrollment to the end of the follow-up assessment at 6-months.
measure: Cognitive Emotion Regulation Questionnaire
timeFrame: From enrollment to the end of the follow-up assessment at 6-months.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: 8980 Villa La Jolla Drive
state: California
Study officials:
References: