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治験 NCT06981598 (IOS Toolkit)(対象:うつ病、不安、悲嘆、リーダーシップ、Dissatisfaction)は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
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Prevention of Psychological Health Problems Via Integrated Operational Support (IOS Toolkit)

募集中
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます!「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06981598 (IOS Toolkit) は 介入研究 臨床試験 で、うつ病、不安、悲嘆、リーダーシップ、Dissatisfaction に関するものです。現在は 募集中 で、2025年3月10日 から開始しています。5,586 名の参加者 の募集が計画されています。この治験は ニューヨーク大学 によって主催され、2028年3月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年5月21日 です。
概要
Sub-clinical behavioral health services in the military are performed by BH technicians, who receive minimal training. Due to this, embedding more technicians in military units is unlikely to benefit service members. Giving technicians training in, and access to, evidence-based interventions (EBI) could make their work more effective. The proposed study is a training trial examining the efficacy of the full integrated operational support (IOS) toolkit (evidence-based interventions for behavioral health), relative to routine care using standard resources, as a prevention resource for active-duty airmen.
詳細説明
This study is conducted in collaboration with the Department of the Air Force (DAF) Medical Service to enhance the effectiveness of embedded behavioral health (BH) technicians in operational units. The initiative aligns with military health goals by embedding paraprofessional BH technicians within line units to improve service member (SM) access to mental health care, reduce stigma, and address risk factors such as sleep disorders, stress, trauma, and suicide prevention. However, variability in training and intervention delivery has limited their effectiveness. This research aims to test evidence-based training (EBT) approaches for BH technicians, equipping them with validated intervention tools and engagement techniques to improve SM psychological well-being, stress management, and service satisfaction.

The research builds on previous findings showing that embedded BH technicians increase accessibility and reduce stigma but often lack standardized training and structured intervention tools. The study will use a randomized controlled trial (RCT) design to compare trained vs. untrained BH technicians, assessing their adoption of evidence-based interventions (EBIs) and the resulting impact on SM well-being. The CBPR advisory board, which has guided the development of the IOS EBI Toolkit, will continue its role in refining training methods and implementation. Additionally, a patient advocate consultant, who has experienced suicidality, PTSD, and sleep disorders, will contribute to recruitment strategies and intervention refinement. This approach ensures that training is optimized for real-world military settings, increasing adoption and effectiveness.

The study's objectives are to evaluate whether EBI training improves BH technicians' adoption of intervention tools and SM outcomes, test whether BH technician competency mediates SM improvement, and deliver empirically supported training protocols to the DAF. The research aims to enhance the quality and impact of BH services in operational units, ultimately improving SM resilience, recovery, and mission readiness. By formalizing structured training programs and evidence-based engagement strategies, this initiative seeks to standardize and optimize the role of embedded BH technicians, ensuring they effectively support service members' mental health needs. If successful, these training protocols will be scaled for military-wide implementation, contributing to long-term mental health improvements across the DAF and broader military community.

公式タイトル

Optimizing Psychological Health and Preventing Clinical Problems: Testing the Effectiveness of an Evidence-Based Toolkit for Integrated Operational Support

疾患/病気
うつ病、不安悲嘆リーダーシップDissatisfaction
その他の研究識別子
  • IOS Toolkit
  • IRB-FY2023-7921
NCT番号
開始日
2025-03-10
最終更新日
2025-05-21
終了予定日
2028-03-01
目標参加者数
5,586
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
主目的
医療サービス研究
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし(非盲検)
群(アーム)/介入
参加グループ/群介入/治療法
実験的BH Technician Training
BH Technician Training; active deliberate practice training
Cognitive Behavioral Coaching Training
Behavioral technicians will engage in a structured, deliberate-practice-based training program designed to enhance competence in evidence-based interventions (EBIs) over a 10-week period. The program begins with an initial seminar that provides an overview of the training framework, key research supporting deliberate practice, and specific intervention techniques. Each participant is assigned a coach-either a clinical psychologist or a licensed MSW with expertise in the EBI Toolkit-who will provide individualized guidance throughout the training. During the weekly coaching sessions, participants will review session notes, engage in structured practice exercises, and work toward mastering the skills and competencies necessary for effective intervention delivery. Weekly homework assignments will allow participants to practice each tool as though they were working with an SM client, followed by self-reflections that will be discussed in coaching sessions.
主要評価項目
評価指標指標の説明時間枠
Average Satisfaction of Service Members (SM) with Embedded Behavioral Health Technician (BHT) Services
We will ask participating SMs questions about their session with their embedded BHT to gauge their satisfaction with the experience. The questions are prompts such as "How much do you think your meeting today will help you deal with your current difficulties?" and How much do you think working with a MHT/BHT/psych/4C will help you improve the things you would like to change?"
From the SM's first session with their embedded BHT to their last session (up to 10 weeks)
Change in Service Member PHQ-9 (Patient Health Questionnaire-9) Score
The PHQ-9 (Patient Health Questionnaire-9) measures physical, emotional, and cognitive symptoms of Major Depression such as "feeling down, depressed, or hopeless," "trouble falling or staying asleep, or sleeping too much," or "trouble concentrating on things, such as reading the newspaper or watching television." Service members (SM) will fill out this measure.
From the SM's first session with their embedded BHT to one month after their last session with their embedded BHT (up to 14 months after the completion of the baseline survey after the first appointment with their embedded BHT)
Change in Service Member WHO-5 Well-being Index Score
The WHO-5 Well-being Index measures general well-being with prompts such as "I have felt cheerful and in good spirits" and "I woke up feeling fresh and rested." Service members (SM) will fill out this measure.
From the SM's first session with their embedded BHT to one month after their last session with their embedded BHT (up to 14 months after the completion of the baseline survey after the first appointment with their embedded BHT)
Change in Service Member PSS-10 (Perceived Stress Scale - 10 item version) Score
The PSS-10 (Perceived Stress Scale - 10 item version) measures the SM's stress with prompts such as: "In the last month, how often have you felt that you were unable to control the important things in your life?" and "In the last month, how often have you felt that you were on top of things?" Service members (SM) will fill out this measure.
From the SM's first session with their embedded BHT to one month after their last session with their embedded BHT (up to 14 months after the completion of the baseline survey after the first appointment with their embedded BHT)
Change in Service Member STAI (State-Trait Anxiety Inventory) Score
The STAI (State-Trait Anxiety Inventory) measures anxiety by asking participants about their current emotions with prompts such as "I feel calm," "I feel frightened," and "I feel nervous." Service members (SM) will fill out this measure.
From the SM's first session with their embedded BHT to one month after their last session with their embedded BHT (up to 14 months after the completion of the baseline survey after the first appointment with their embedded BHT)
副次評価項目
評価指標指標の説明時間枠
Frequency of evidence based intervention (EBI) use among behavioral health technicians (BHT) following IOS Toolkit Cognitive Behavioral Coaching training
The percentage of all interventions offered by BHTs while treating service members that are evidence based will be compared to the percentage that are not evidence based from pre-training (10-week period) to post-training (10-week period).
Pre-training (10-week period) to post-training (10-week period)
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
  • Service members seeing a behavioral health (BH) technician.
  • Currently embedded BH technicians.

  • Service members who are not currently seeing a BH technician.
  • BH technicians who are not embedded or have taken a clinic role.
試験中央連絡先
連絡先: Kelly Daly, PhD, 914-806-5093, [email protected]
連絡先: Ana Ivic, LMSW, 9143195245, [email protected]
1 1カ国の場所

New York

New York University, New York, New York, 10016, United States
Amy S Slep, PhD, 連絡先, [email protected]
Ana Ivic, LMSW, 連絡先, 9143195245, [email protected]
募集中