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

NCT07749391 | Active Not Recruiting DMC

• 2 other identifiers: 806080YIG-0-078-22
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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 = 10), we 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. They 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 dats, 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. We will obtain feedback from these initial participants and refine the intervention. We will then pilot test the intervention in an open-label non-randomized trial (N = 40), again recruiting students from the university counseling center. We 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. We 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.

Conditions

Suicidal Thoughts and Behaviors

Keywords

personalized medicine; dialectical behavior therapy; safety planning; emotion regulation; clinical psychology; psychiatry

Outcome Measures

Primary Outcomes (2)

• Suicidal Thoughts and Behaviors

  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

  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 Outcomes (2)

• Change in Negative Emotion Intensity

  Baseline through 6-weeks

• Change in Adaptive Emotion Regulation Strategy Use

  Baseline through 6-weeks

Study Arms (1)

PRECISE

EXPERIMENTAL

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

Interventions

PRECISE BEHAVIORAL

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.

PRECISE

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Stein Clinical Research Building

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Suicidal Ideation; Behavior; Emotional Regulation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Self-Control; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants receive the PRECISE intervention in a single-arm, open-label design. The study is conducted in two sequential, non-randomized phases: an initial feasibility phase (n=5) to refine the intervention, followed by a pilot phase (n=30) using the refined intervention protocol to further evaluate feasibility, acceptability, and preliminary outcomes. There is no control or comparison group.

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 6, 2026
• Study Start: May 23, 2024
• Primary Completion (Estimated): September 3, 2026
• Study Completion (Estimated): September 3, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Mid-September 2026. Will be available indefinitely
• Access Criteria: Open access

Locations

US (1)