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The Many Roads to Trauma Recovery: A Clinical Trial Comparing Empirically Supported Treatments for Veterans With Co-Morbid Posttraumatic Stress and Substance Use Disorder Symptoms

2026年8月7日 更新者：Alexander Puhalla、Coatesville VA Medical Center
Veterans with co-morbid posttraumatic stress disorder (PTSD) and substance use disorders (SUDs) are at substantial risk of developing hypertension and cardiovascular diseases that often lead to premature death, with some evidence that they may die over 10 years earlier than their counterparts. As such, determining ways to improve their health outcomes is vital. Heart Rate Variability Biofeedback (HRVB) may be one way to restore autonomic balance and teach veterans with PTSD / SUDs how to respond differently to their symptoms. Multiple studies have found that HRVB not only improves autonomic nervous system (ANS) regulation / flexibility among veterans with PTSD, but also reduces PTSD symptoms. Additionally, there is evidence that HRVB reduces cravings and SUD symptoms. Currently it is proposed that the improvement in the PTSD and SUD symptoms are due to a combination of improving ANS regulation and veterans utilizing the HRVB techniques as coping strategies for their symptoms. Yet, none of these studies examined how HRVB versus other active interventions differentially effected symptoms and physiological outcomes. It may be useful to examine HRVB to other active interventions . The current project proposes to alleviate this gap by examining the effects of HRVB to one a active control condition (i.e., Present Centered Psychotherapy; PCT) among 50-residential veterans engaging in PTSD residential programming. Veterans will be recruited from residential programs at the Coatesville VAMC and screened for probable PTSD and an active (i.e., past year) SUD. If eligible, they will attend a brief visit that will include being randomized, engaging in a diagnostic interview, a battery of questionnaires related to PTSD / SUDs, attached to physiology equipment, and then complete 3 tasks (i.e., baseline task, emotion induction, and HRVB or Self-Compassion Break). Upon task completion, all veterans will be screened for risk and begin one of the conditions. Similar research procedures will be conducted after their final session. This study would provide evidence for the real-world effectiveness of HRVB compared to a control condition among one of the highest risk populations treated at the VA, which may provide invaluable insight into active mind-body treatments for veterans with PTSD / SUD.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

50

阶段

  • 阶段2
  • 第三阶段

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
    • Pennsylvania
      • Coatesville、Pennsylvania、美国、19320
        • 招聘中
        • Coatesville VA Medical Center
        • 接触：

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:

  • PTSD diagnosis
  • Enrolled in VA healthcare
  • Attending residential programming at CVAMC
  • Current substance use difficulty based on screening questions

Exclusion Criteria:

  • Non-English speaking
  • Inability to complete study procedures
  • Lack competency to provide consent
  • Acute intoxication of a substance
  • Active psychotic symptoms at the study visit
  • Suicidal or homicidal ideation with intent and planning
  • Pacemaker or other cardiovascular implants.

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：随机化
  • 介入模型：并行分配
  • 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：Trauma Informed Heart Rate Variability Biofeedback (T-HRVB)
HRVB is a specific intervention that increases HRV by finding the optimal breathing frequency that will synchronize with HR oscillations (i.e., between 4 to 7 breaths per minute), increase the amount and intensity of HR variation while engaging in the biofeedback, and overtime improve HRV and overall functioning by activating both the vagus nerve and baroreceptor during practice. T-HRVB is a six session flexible protocol that integrates active trauma informed psychotherapy into HRVB, as well as scaffolds breathing skills based on the needs of population and encourages the use of these skills as active coping skills (Puhalla et al., 2026). Additionally, active psychotherapy skills are utilized throughout to bolster a sense of agency and engagement with the techniques.
行为的：Trauma Informed Heart Rate Variability Biofeedback
please see description in the arm of the study for details.
有源比较器：Present Centered Therapy (PCT)
The PCT condition will be the study's control condition where veterans will engage in six sessions. While PCT has shown some effect on improving PTSD symptoms, , it is generally a non-specific therapeutic modality where the therapist provides support and validation for the patient and encouragement towards their goal of stress reduction. In accordance with the study, six sessions will be provided with the psychoeducation on PTSD and the homework sheet being provided in session one since an intake has already occurred with their non-research provider.
行为的：Present Centered Therapy
please see description in the arm of the study for details.

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
Clinician Administered PTSD Scale for DSM-5 Revised
大体时间：The CAPS-5-R is conducted at the pre and post treatment visit, which typically will occur during the 1st week of treatment and the last. However, due to scheduling needs may occur a prior (pre) or following (post) week.
The CAPS-5-R is the newest version of the CAPS-5, which is a structured diagnostic interview for PTSD based on the PTSD criteria in the DSM-5. All 20 symptoms of PTSD are assessed in relation to a patient's index event, which is then rated on a zero to ten severity scale with qualitative and quantitative indicators for each level of severity. Throughout the assessment symptoms that are less trauma specific include a prompt to determine if the symptom is related to the index event. The CAPS-5-R will be the studies primary outcome variable for PTSD symptom severity.
The CAPS-5-R is conducted at the pre and post treatment visit, which typically will occur during the 1st week of treatment and the last. However, due to scheduling needs may occur a prior (pre) or following (post) week.
Heart Rate (HR)
大体时间：Assessed at the pre and post treatment visits, with the primary outcome being the baseline measures of the variable.
Heart Rate will be utilized as the study's primary measure of overall autonomic arousal.
Assessed at the pre and post treatment visits, with the primary outcome being the baseline measures of the variable.
Respiratory Sinus Arrythmia
大体时间：Assessed at the pre and post treatment visits, with the primary outcome being the baseline measures of the variable.
To determine parasympathetic activity, the R-spike to R-spike interval will go through a Fourier transformation and the amount of power that occurs in the high frequency range (0.15-0.04 Hz) will be used as our measure of vagal mediated parasympathetic activity, also known as RSA.
Assessed at the pre and post treatment visits, with the primary outcome being the baseline measures of the variable.
Skin Conductance Level
大体时间：Assessed at the pre and post treatment visits, with the primary outcome being the baseline measures of the variable.
Resting Skin Conductance Level may be used as proxy of sympathetic activity at rest, which is collected through a skin conductance monitor on the participants palm / fingers.
Assessed at the pre and post treatment visits, with the primary outcome being the baseline measures of the variable.

次要结果测量

结果测量
措施说明
大体时间
PTSD Symptom Checklist for the DSM-5 (PCL-5)
大体时间：Provided at the pre and post treatment visit, which typically will occur during the 1st week of treatment and the last. However, due to scheduling needs may occur a prior (pre) or following (post) week.
The PCL-5 is 20-item self-report questionnaire that assesses each symptom of PTSD on a 5-point Likert Scale. The PCL-5 will be used to assess for PTSD symptom severity
Provided at the pre and post treatment visit, which typically will occur during the 1st week of treatment and the last. However, due to scheduling needs may occur a prior (pre) or following (post) week.
Root Mean Square of Successive Differences (Rmssd)
大体时间：Rmssd will be assessed at the pre and post treatment visits, with the baseline measure being a primary outcome at both timepoints.
Rmssd is a time-domain measure of vagal mediated parasympathetic activity that is determined by calculating the root mean square of successive differences within a heart beat to heart beat interval (R to R interval). It is commonly used as a proxy for parasmypathetic activity or regulation.
Rmssd will be assessed at the pre and post treatment visits, with the baseline measure being a primary outcome at both timepoints.
Standard Deviation between Normal to Nrmal intervals (SDNN).
大体时间：Assessed at the pre and post treatment visits, with the primary outcome being the baseline measures of the variable.
SDNN is a time domain HRV measure that acts as a proxy for overall autonomic nervous system activity and health, with greater levels usually indicative of greater health.
Assessed at the pre and post treatment visits, with the primary outcome being the baseline measures of the variable.

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

Coatesville VA Medical Center

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)

2026年8月1日

初级完成 (估计的)

2029年8月1日

研究完成 (估计的)

2030年8月1日

研究注册日期

首次提交

2026年8月7日

首先提交符合 QC 标准的

2026年8月7日

首次发布 (实际的)

2026年8月11日

研究记录更新

最后更新发布 (实际的)

2026年8月11日

上次提交的符合 QC 标准的更新

2026年8月7日

最后验证

2026年8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

  • 1882489

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Directly states within the consent form that the data would not be shared outside of the research team due to the high sensitivity of the data being collected.

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

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.

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