Stein Clinical Research Building
La Jolla, California, 92093, United States
NCT Number: NCT07749391
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–26 year
All sexes
Interventional
Not applicable
La Jolla, California, 92093, United States
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 SPRING 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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
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.
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.
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.
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. Within-person trajectories of negative emotion will be analyzed using mixed-effects models to account for the nested structure of repeated EMA observations.
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). Strategy use is tracked weekly by the treatment coach and measured via EMA. Within-person trajectories will be analyzed using mixed-effects models.
University of California, San Diego
Other
Acronym: AFSP_PRECISE
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