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

9 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

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).

Tipo de estudio

Intervencionista

Inscripción (Actual)

35

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • California
      • La Jolla, California, Estados Unidos, 92093
        • Stein Clinical Research Building

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Suicidal Thoughts and Behaviors
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Negative Emotion Intensity
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

23 de mayo de 2024

Finalización primaria (Actual)

9 de septiembre de 2026

Finalización del estudio (Actual)

9 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

31 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

31 de julio de 2026

Publicado por primera vez (Actual)

6 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 806080
  • YIG-0-078-22 (Otro número de subvención/financiamiento: American Foundation for Suicide Prevention)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

Mid-September 2026. Will be available indefinitely

Criterios de acceso compartido de IPD

Open access

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • CÓDIGO_ANALÍTICO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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