Suicidal Thoughts and BehaviorsNCT06809348
Development of PRECISE: A Data Driven Personalized Suicide Prevention Intervention
A study testing PRECISE in people with Suicidal Thoughts and Behaviors, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicidal Thoughts and Behaviors
- What is being tested?
- PRECISE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2025to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
8980 Villa La Jolla Drive
San Diego, California, 92037
Kevin S Kuehn, Ph.D., (619) 543-5221, kskuehn@health.ucsd.edu
About this study
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.
- Conditions
- Suicidal Thoughts and Behaviors
- Being tested
- PRECISE
- Keywords
- personalized interventions, intensive longitudinal data, emotion regulation, coping, coping skills, dialectical behavior therapy, cognitive behavior therapy, ecological momentary assessment, personalized feedback, technology, coaching
- Medical subject headings
- Suicidal Ideation, Behavior, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRECISEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity | Experimental | 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. Receives: Behavioral: PRECISE |
| Low-Intensity | Experimental | 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. Receives: Behavioral: PRECISE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the follow-up assessment at 6-months.
Secondary outcomes (2)
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.
Measured: 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.
Measured: From enrollment to the end of the follow-up assessment at 6-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start14 Nov 2025
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal Thoughts and BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Kuehn, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809348
- Sponsor's protocol ID
- 811796
- Status last verified
- Apr 2026
- First submitted
- 24 Jan 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of PRECISE: A Data Driven Personalized Suicide Prevention Intervention
- ClinicalTrials.gov ID
- NCT06809348
- Acronym / sponsor ID
- 811796
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Intensity | Experimental | Behavioral: PRECISEIn 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. |
| Low-Intensity | Experimental | Behavioral: PRECISEIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRECISEPRECISE 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. | Behavioural | High-Intensity, Low-Intensity |
Primary outcome
Scale for Suicide Ideation
Time frame: 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.
2 secondary outcomes
Emotion Reactivity Scale
Time frame: From enrollment to the end of the follow-up assessment at 6-months.
Cognitive Emotion Regulation Questionnaire
Time frame: From enrollment to the end of the follow-up assessment at 6-months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRECISE in people with Suicidal Thoughts and Behaviors, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin S Kuehn, Ph.D. ((619) 543-5221, kskuehn@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale for Suicide Ideation (time frame: From enrollment to the end of the follow-up assessment at 6-months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.