Developing and Testing a Brief, Personalized Intervention for Suicidal Thoughts and Behaviors (AFSP_PRECISE)

August 20, 2026 updated by: Kevin Kuehn, University of California, San Diego
Suicide is a leading cause of death in the United States and around the world. Individuals at high-risk for suicide are heterogenous. Despite this heterogeneity, interventions are often developed and tested assuming that suicidal thoughts and behaviors are caused by common factors. The proposed research uses person-specific idiographic quantitative techniques to inform intervention development. In the first aim (N = 5), the investigators will refine a brief, personalized, and adjunctive intervention to help reduce emotional distress, increase effective emotion regulation strategies, and decrease suicidal thoughts. Participants will be recruited from the university counseling center. Participants will then complete six weeks of surveys delivered to their smartphones (5x/day), answering questions about their emotional states, emotion regulation, and suicidal thoughts and behaviors. After the first 14 days, individual participant data will then be analyzed using idiographic techniques (n=1) to identify person-specific correlates of suicidal thoughts. Participants will meet with a coach to complete a risk assessment, review idiographic data, learn personally tailored skills from dialectical behavior therapy, and finish a personalized safety plan. Participants will be offered up to six sessions. Between sessions, participants will continue to complete surveys to measure progress and update idiographic models. The investigators will obtain feedback from these initial participants and refine the intervention. The investigators will then pilot test the intervention in an open-label non-randomized trial (N = 30), again recruiting students from the university counseling center. The investigators anticipate the intervention will be feasible and acceptable, and that participants' emotional distress will decrease, effective emotion regulation strategies increase, and suicidal thoughts decrease by the end of the six-week intervention. The investigators hope to test this intervention in a sequential multiple-assignment randomized trial. The proposed research marks an initial attempt at developing personalized interventions based on person-specific correlates of suicidal thoughts.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Suicide is a public health emergency: an estimated 45,979 people in the United States died by suicide in 2020, and approximately 20% of U.S. youth report having seriously contemplated suicide in the past year. Most interventions for suicidal thoughts and behaviors (STBs) are developed and tested using group-level (nomothetic) approaches, which assume that all individuals experience suicidal ideation for similar reasons and respond similarly to treatment. However, individuals at high risk for suicide are highly heterogeneous, and prior idiographic (person-specific) research has shown substantial between-person variability in the daily associations between suicidal thoughts and coping strategies. This suggests that personalized interventions, tailored to an individual's unique pattern of risk and coping, may be more effective than one-size-fits-all approaches.

Dialectical behavior therapy (DBT) is an evidence-based treatment for self-injurious behavior, but standard DBT is resource-intensive, creating barriers to access. Brief, adjunctive interventions show promise for reducing mental health symptoms and increasing engagement with more intensive services, but existing brief options (e.g., crisis lines) are underused. There is a need for a brief intervention that retains DBT's active ingredients while being personalized and more accessible than standard care.

This study will develop and pilot test PRECISE, a brief, personalized, EMA-informed adjunctive intervention for suicidal thoughts and behaviors, delivered via secure videoconferencing by trained coaches. PRECISE integrates components of DBT with idiographic statistical modeling of each participant's own ecological momentary assessment (EMA) data to identify individualized correlates of suicidal thoughts, which then guide functional analysis, safety planning, and targeted skills coaching across up to six sessions.

Aim 1 (Months 1-12): Refine the PRECISE intervention manual through expert advisory review and initial testing with 5 participants to evaluate feasibility and acceptability.

Aim 2 (Months 13-24): Conduct an open-label, non-randomized pilot trial in 30 participants to evaluate recruitment/retention feasibility, further refine the intervention, and preliminarily examine outcomes.

Eligible participants (ages 18-26, active suicidal ideation, English fluency) complete baseline assessments, then begin smartphone-based EMA surveys for the six-week intervention duration. Each session opens with a suicide risk assessment; at-risk participants complete a structured risk management protocol. Primary outcomes are change in negative emotion intensity and adaptive emotion regulation strategy use, analyzed via mixed-effects models. Secondary outcomes include suicidal ideation, coping self-efficacy, and implementation outcomes (adherence, dropout, satisfaction).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • Stein Clinical Research Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-26 years
  • Endorsement of active suicidal ideation on the Columbia-Suicide Severity Rating Scale (C-SSRS) (score >2, or past-month thoughts of killing self)
  • English fluency
  • Willingness to provide contact information for a key support person to be contacted as part of the study's risk and safety plan

Exclusion Criteria:

  • Unable to read English
  • Diagnosis of a psychotic or severe thought disorder (e.g., schizophrenia, bipolar disorder with psychotic features)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PRECISE
All enrolled participants receive the PRECISE intervention, a brief (up to six sessions over six weeks), personalized, EMA-informed adjunctive intervention for suicidal thoughts and behaviors, delivered via secure videoconferencing by trained coaches. Sessions incorporate idiographic analysis of participants' own ecological momentary assessment (EMA) data to identify personalized correlates of suicidal thoughts, which inform functional analysis, safety planning, and targeted emotion regulation skills coaching. Each session begins with a suicide risk assessment; participants at acute risk complete a structured risk management protocol. Participants also complete smartphone-based EMA surveys multiple times daily throughout the six-week intervention period.
Behavioral: PRECISE
All enrolled participants receive the PRECISE intervention, a brief (up to six sessions over six weeks), personalized, EMA-informed adjunctive intervention for suicidal thoughts and behaviors, delivered via secure videoconferencing by trained coaches. Sessions incorporate idiographic analysis of participants' own ecological momentary assessment (EMA) data to identify personalized correlates of suicidal thoughts, which inform functional analysis, safety planning, and targeted emotion regulation skills coaching. Each session begins with a suicide risk assessment; participants at acute risk complete a structured risk management protocol. Participants also complete smartphone-based EMA surveys multiple times daily throughout the six-week intervention period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Suicidal Thoughts and Behaviors
Time Frame: Baseline, 6-weeks, 12-weeks
Suicidal ideation and behavior assessed via the Columbia-Suicide Severity Rating Scale (C-SSRS), a structured interview administered by a trained assessor. The C-SSRS rates suicidal ideation along a severity continuum (from passive wish to be dead through active ideation with specific plan and intent) and separately captures suicidal behavior (actual, interrupted, and aborted attempts; preparatory acts; and non-suicidal self-injury). Ideation intensity (frequency, duration, controllability, deterrents, reasons for ideation) is also assessed.
Baseline, 6-weeks, 12-weeks
Suicidal Ideation
Time Frame: Baseline, 6-weeks, 12-weeks
Suicidal ideation severity assessed via the Modified Scale for Suicide Ideation (MSSI), a clinician-administered rating scale adapted from Beck's original Scale for Suicide Ideation (SSI). The MSSI extends the original SSI with additional items assessing components such as desire to live, desire to die, deterrents to suicide, and courage/competence to attempt, yielding a broader assessment of ideation severity and risk than the original scale.
Baseline, 6-weeks, 12-weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Negative Emotion Intensity
Time Frame: Baseline through 6-weeks
Change in self-reported negative emotion intensity, assessed via ecological momentary assessment (EMA) surveys completed up to five times daily throughout the intervention period. These items (fear, shame, sadness, anger, guilt), measured on a 0-100 scale, are adapted from Positive Affect Negative Affect Schedule (PANAS) with higher scores indicating greater degree of negative emotions. The Within-person trajectories of negative emotion will be analyzed using mixed-effects models to account for the nested structure of repeated EMA observations.
Baseline through 6-weeks
Change in Adaptive Emotion Regulation Strategy Use
Time Frame: Baseline through 6-weeks
Change in use of adaptive (vs. maladaptive) emotion regulation strategies, calculated as a proportion score reflecting personalized strategies identified for each participant (e.g., problem-solving, cognitive reappraisal, acceptance) relative to strategies targeted for reduction (e.g., rumination, avoidance, suppression). These items are adapted from the Cognitive Emotion Regulation Questionnaire (CERQ), with higher scores indicating greater use of maladaptive strategies relative to adaptive ones. The proportion score ranges from 0 to 1. Strategy use is tracked weekly by the treatment coach and measured via EMA. Within-person trajectories will be analyzed using mixed-effects models.
Baseline through 6-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 3, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 3, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 806080
  • YIG-0-078-22 (Other Grant/Funding Number: American Foundation for Suicide Prevention)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data, including baseline assessment measures and aggregated ecological momentary assessment (EMA) data, will be made publicly available via GitHub (https://github.com/kskuehn) following completion of the primary analyses and manuscript preparation. Data will be stripped of direct identifiers prior to posting. This data sharing plan is described in the study's informed consent document.

IPD Sharing Time Frame

Mid-September 2026. Will be available indefinitely

IPD Sharing Access Criteria

Open access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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