Developing and Testing a Brief, Personalized Intervention for Suicidal Thoughts and Behaviors (AFSP_PRECISE)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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La Jolla, California, Estados Unidos, 92093
- Stein Clinical Research Building
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Suicidal Thoughts and Behaviors
Prazo: Baseline, 6-weeks, 12-weeks
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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.
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Baseline, 6-weeks, 12-weeks
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Suicidal Ideation
Prazo: Baseline, 6-weeks, 12-weeks
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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.
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Baseline, 6-weeks, 12-weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Negative Emotion Intensity
Prazo: Baseline through 6-weeks
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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.
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Baseline through 6-weeks
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Change in Adaptive Emotion Regulation Strategy Use
Prazo: Baseline through 6-weeks
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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.
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Baseline through 6-weeks
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 806080
- YIG-0-078-22 (Número de outro subsídio/financiamento: American Foundation for Suicide Prevention)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
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