此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Applying Mixed Methods to Identify Links Between PTSD Symptoms, Cannabis Use, and Functional Behaviors With Personalized Feedback Intervention Development

2026年7月24日 更新者：VA Office of Research and Development
Many Veterans live with posttraumatic stress disorder (PTSD) and use cannabis to manage distress, despite limited supportive evidence. Veterans with PTSD who use cannabis often struggle with sleep, physical activity, and social connection, which are factors critical to health and well-being. This project will use smartphones and wearable devices to track symptoms and daily behaviors in real time and provide personalized feedback to help Veterans understand and manage the impact of PTSD and cannabis use in their lives. The study will develop a motivational interviewing-based personalized feedback approach that uses real-time data to help Veterans make data-informed decisions about their mental health, cannabis use, and functional behaviors. Findings will support development of scalable, Veteran-centered tools to promote healthier coping, functional recovery, and quality of life, even if they are not currently in treatment. The goal is to develop supportive, real-time strategies that meet Veterans where they are and promote better outcomes across the VA healthcare system.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Posttraumatic stress disorder (PTSD) and cannabis use are highly prevalent among Veterans, frequently co-occurring in ways that compound impairment and reduce quality of life. Many Veterans use cannabis to manage PTSD symptoms despite limited empirical support. Although the 2023 VA/DoD Clinical Practice Guidelines advise against cannabis for PTSD, a significant proportion of Veterans continue to use it. Both PTSD and cannabis use independently impair psychosocial functioning, and their combined day-to-day impact remains poorly understood. This CDA-2 focuses on developing and refining a motivational interviewing (MI)-based, personalized feedback approach that uses real-time data to help Veterans better understand how cannabis use relates to PTSD symptoms and daily functioning, with the goal of supporting healthier coping and functional recovery. This project uses ecological momentary assessment (EMA) and wearable activity tracking to support the development and refinement of an MI-based personalized feedback session for Veterans with PTSD who use cannabis. This personalized, data-driven approach yields foundational tools for future VA implementation.

Sixty Veterans with PTSD and regular cannabis use will complete a 14-day EMA protocol (3 random prompts, 2 daily diaries per day) and Fitbit tracking. The study will use a phased design. Phase 1 (n=20) informs PFS development. Phase 2 (n=10) pilots the 1st iteration PFS. Using qualitative feedback from Phase 2 participants and experts, the 2nd iteration PFS will be developed and piloted with a single-arm design in Phase 3 (n=30). Phase 3 tests the 2nd iteration PFS with 1- and 3-month follow-up assessments. Similarly, qualitative feedback will be gathered from Phase 3 participants to further refine the PFS for use in a future VA Merit Award randomized clinical trial. Outcomes include real-time reports of PTSD symptoms, cannabis use episodes, and functioning domains, analyzed using multilevel and network models. This CDA-2 will generate the empirical and methodological foundation needed to support a future VA Merit Award focused on fully testing an MI-based personalized feedback session. The long-term goal is to build the foundation for scalable self-management tools that support functioning and recovery among Veterans with co-occurring PTSD and cannabis use within the VA healthcare system.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • California
      • San Diego、California、美国、92161-0002
        • VA San Diego Healthcare System, San Diego, CA
        • 接触：
        • 首席研究员：
          • Terrell A. Hicks, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. U.S. Military Veterans
  2. DSM-5 PTSD diagnosis verified by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
  3. Cannabis use at least once per week over the past 3 months
  4. If on psychotropic medication or in psychotherapy (excluding trauma-focused PTSD therapy; see exclusion criteria), regimen must be stable for =1 month
  5. English-speaking and reading
  6. Willing and able to use a smartphone and wearable device for 2 weeks

Exclusion Criteria:

  1. Severe substance use disorder (excluding cannabis), as acute withdrawal or other drug effects could confound data; mild/moderate non-cannabis disorders permitted with monitoring
  2. Lifetime diagnosis of schizophrenia or other primary psychotic disorder due to potential confounding of EMA responses
  3. Severe depression or high suicide risk; such Veterans will be referred for treatment and may be re-evaluated once stabilized
  4. Cognitive or neurodegenerative disorder impairing ability to use EMA tools (e.g., moderate/severe TBI or dementia)
  5. Veterans currently engaged in evidence-based trauma-focused therapy (e.g., CPT, PE, EMDR), will be excluded to isolate naturalistic symptom variability, as therapy can substantially impact PTSD symptoms; these individuals will be invited to re-contact the study post-treatment for consideration
  6. Lack of smartphone ownership

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Personalized Feedback Session (PFS)
30 Veterans will complete baseline assessments, 14 days of ecological momentary assessment (EMA) and wearable monitoring, and receive the refined, second-iteration Personalized Feedback Session (PFS). Participants will complete follow-up assessments at 1- and 3-months post-PFS to evaluate feasibility, acceptability, and preliminary efficacy on PTSD symptoms, cannabis use, and daily functioning.
行为的：Personalized Feedback Session (PFS)
The Personalized Feedback Session (PFS) is an MI-based, individualized brief intervention designed to help Veterans understand how their own PTSD symptoms, cannabis use behaviors, and daily functioning behaviors interact in real time. The PFS integrates baseline assessment data and 14 days of EMA and wearable (Fitbit) data to generate personalized visualizations and feedback aimed at reducing unhelpful, cannabis use, encouraging engagement in evidence-based supported PTSD management, and supporting improvements in functioning. The PFS will be delivered individually via secure VA Video Connect or in-person and will last approximately 60 minutes.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
PTSD Checklist (PCL-5)
大体时间：Baseline through 1- and 3-month follow-up
The PTSD Checklist for DSM-5 (PCL-5) will measure past month PTSD symptom severity. The PCL-5 is a 20-item self-report measure of PTSD symptoms that maps directly onto the DSM-5 criteria55. Veterans rate how much each problem has bothered them in the last 30 days on a 0 ("Not at all") to 4 ("Extremely") scale. Summed scores range from 0 to 80, with higher scores indicating greater symptom burden.
Baseline through 1- and 3-month follow-up
Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU)
大体时间：Baseline through 1- and 3-month follow-up
The Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU) will assess multiple dimensions of cannabis use patterns, including frequency, age of initiation, and quantity consumed in various forms (smoked flower, vaping concentrates, edibles, etc.). The DFAQ-CU is a self-report measure that asks participants to estimate average number of cannabis use sessions per day, typical days per week, age at first use, and usual quantity consumed per session using common user-friendly units (e.g., joints/bowls, grams, milligrams THC).
Baseline through 1- and 3-month follow-up
Inventory of Psychosocial Functioning (IPF)
大体时间：Baseline through 1- and 3-month follow-up
The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure of PTSD-related functional impairment during the past 30 days. Items cover seven domains: romantic relationships, family relationships, work, friendships/socializing, parenting, education, and self-care. Each behavior is rated on a 7-point Likert scale (1 = "never/almost never" to 7 = "always/almost always"), with lower scores indicating poorer functioning.
Baseline through 1- and 3-month follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

VA Office of Research and Development

调查人员

  • 首席研究员：Terrell A. Hicks, PhD、VA San Diego Healthcare System, San Diego, CA

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年1月1日

初级完成 (估计的)

2031年12月31日

研究完成 (估计的)

2031年12月31日

研究注册日期

首次提交

2026年7月17日

首先提交符合 QC 标准的

2026年7月17日

首次发布 (实际的)

2026年7月23日

研究记录更新

最后更新发布 (实际的)

2026年7月27日

上次提交的符合 QC 标准的更新

2026年7月24日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • RRD9-007-25W
  • IK2RD001926 (其他赠款/资助编号：Department of Veterans Affairs)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Data sets without personal identifiers will be generated. Any HIPPA identifiers, or combinations of variables that could be used for re-identification, will be excluded, as will any proprietary information. The plan does not include any access to individually identifiable or proprietary data. Therefore, this plan will ensure the protection of personal privacy, the confidentiality of individually identifiable private information, and the security of the proprietary data and information.

IPD 共享时间框架

One or more data sets without personal identifiers will be generated during the data analysis phase of this study. The data sets will include all data underlying any publications generated by this study and therefore these will be sufficient to reproduce or verify any published findings.

IPD 共享访问标准

Requests for access must be made in writing signed by a requester from the United States and include an email address for delivery and an assurance that the recipient will not attempt to identify or re-identify any individual. The request should reference the publication underlying the request. Requests may be made to the Principal Investigator/lead point-of-contact for the publication. If the investigator leaves the VASDHS the requests may be sent to the Associate Chief of Staff for Research.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅