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

2026年9月9日 更新者: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.

調査の概要

状態

完了

介入・治療

詳細な説明

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).

研究の種類

介入

入学 (実際)

35

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • California
      • La Jolla、California、アメリカ、92093
        • Stein Clinical Research Building

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Suicidal Thoughts and Behaviors
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Negative Emotion Intensity
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年5月23日

一次修了 (実際)

2026年9月9日

研究の完了 (実際)

2026年9月9日

試験登録日

最初に提出

2026年7月31日

QC基準を満たした最初の提出物

2026年7月31日

最初の投稿 (実際)

2026年8月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月11日

QC基準を満たした最後の更新が送信されました

2026年9月9日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 806080
  • YIG-0-078-22 (その他の助成金/資金番号:American Foundation for Suicide Prevention)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

Mid-September 2026. Will be available indefinitely

IPD 共有アクセス基準

Open access

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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