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针对遭受军事性创伤的退伍军人进行以康复为导向的团体治疗

2026年11月4日 更新者:VA Office of Research and Development

针对遭受军事性创伤的退伍军人进行以康复为导向的团体治疗 (CDA 23-054)

VA has identified military sexual trauma (MST) as one of its highest priorities. MST is associated with increased prevalence of PTSD and depression, substance use disorders, suicide, difficulties maintaining relationships and employment, and homelessness. Yet important gender differences have been identified among MST survivors and many man may experience stigma and shame related to masculinity and sexuality. While gender-based shame appears central to MST-related distress and treatment underutilization, gender has often been overlooked in establishing evidence-based approaches, and no VA MST-related treatment has been developed specifically for men. To address this critical service gap, this study will collect data on improving treatment strategies and patient engagement for men with histories of MST. It will seek to develop strategies for enhancing a 12-session, gender-tailored group therapy for men MST survivors previously developed and implemented by the principal investigator. It will interview Veteran participants and mental health clinicians, conduct a pilot randomized trial, and evaluate feasibility within the VA, with the long-term goal of national implementation

研究概览

详细说明

Approximately 3.5% of Veteran men and 44% of Veteran women report a history of military sexual trauma (MST).Although women disproportionately experience MST, the absolute number of men who report MST (55,500 from 2004-2013) is relatively similar due to the larger proportion of men in the military. Further, MST likely remains vastly underreported among men, who experience multiple barriers to disclosure. Men survivors often wait decades to seek care for MST-related distress, contributing to pervasive life impairment.

MST is associated with transdiagnostic complexity and is associated with increased prevalence of PTSD and depression, substance use disorders, suicide, difficulties maintaining relationships and employment, and homelessness. Important gender differences have been identified among MST survivors: men may experience stigma and shame related to masculinity and sexuality; the probability of opioid use disorder among men with a history of MST is nearly double that of women; and men with histories of MST also experience more severe PTSD symptoms, chronic mental health symptoms, sexual dysfunction and distress, and greater risk for homelessness. While gender-based shame appears central to MST-related distress and treatment underutilization, gender has often been overlooked in establishing evidence-based approaches, and no VA MST-related treatment has been developed specifically for men.

To address this critical service gap, I designed a 12-session, gender-tailored, multi-modal, recovery-oriented group therapy for men MST survivors as part of my clinical responsibilities as a VA staff psychologist. My intervention (the Men's MST Group, or MMG), which I have been delivering continuously for 5 years, is based on the Integrated Recovery-oriented Model (IRM) for mental health services, and promotes agency through delivery of dynamic, exposure- and mindfulness-based techniques intended to improve distress management, social belongingness, and hope. This transdiagnostic intervention also seeks to reduce shame. Exploratory evaluation signaled strong retention, as well as recovery and attitudinal shifts, including reductions in shame and PTSD symptoms. As one participant noted after completing the MMG, "I can say the word 'rape' without shame." Given these initial findings, rigorous research is warranted to refine, test, and prepare for implementation of the intervention. Moreover, given the fact that most participants wait decades to seek treatment, more research is needed to facilitate men's utilization of MST-related services. In this proposed CDA, guided by Intervention Mapping and the Access Re-conceptualization Model, I plan to iteratively refine the MMG by interviewing Veteran participants and mental health clinicians, conducting a pilot randomized trial, and evaluating feasibility within the VA, with the long-term goal of national implementation.

This mentored CDA will fill gaps in my training - particularly in gender-tailored intervention development, intersectionality, clinical trials and health services research, and mixed methods - to support my independence as a VA clinician scientist focused on enhancing mental health services for vulnerable Veteran populations. The Specific Aims are to:

Aim 1. Revise the MMG treatment protocol, with attention to factors that will support men's access to, and engagement and retention in, mental health interventions. 1a) Conduct semi-structured qualitative interviews (n=24) with VA mental health clinicians, Vet Center clinicians, MST coordinators, and MST experts. Findings will inform protocol revisions. 1b) Review the revised protocol by conducting two focus groups with the two recent MMG cohorts (n=8). 1c) Convene an Expert Panel with selected Aim 1a participants and VA Operations Partners to finalize the protocol.

Aim 2. Using the revised protocol, conduct a pilot randomized controlled trial (RCT) with men MST survivors (n=32), randomized to the MMG or Present-Centered Group Therapy (PCGT; control condition) (four cohorts: 2 experimental, 2 control). Investigate engagement (session attendance) as well as recovery-oriented outcomes (agency, hope, belongingness, shame-reduction) and psychological symptoms (PTSD, MDD, suicidality) assessed at pre-, immediate post-, and 6-month post-intervention.

Aim 3. Assess pilot RCT findings and plan for multisite trial (Year 5 Merit). 3a) Conduct post-intervention semi-structured interviews with RCT participants and interventionists to understand treatment engagement factors as well as perceptions of accessibility, feasibility, acceptability, appropriateness, and effectiveness. 3b) Reconvene the Aim 1c Expert Panel to discuss RCT results and potential facilitators, barriers, and strategies for implementation of the MMG in usual VA mental health care. 3c) In collaboration with operations partners, enhance the protocol and design the intervention package with system-level considerations in preparation for a multisite trial.

VA has identified MST as one of its highest priorities. Given the prevalence of MST among men and the deleterious, often protracted MST-related symptomatology, it is critical to develop tailored services for this population. This application responds to VA HSR&D's research priorities of suicide prevention, mental health, and health equity, and ORD's priorities of increasing the real-world impact of VA research and actively promoting equity.

研究类型

介入性

注册 (估计的)

32

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

研究联系人备份

学习地点

    • California
      • West Los Angeles、California、美国、90073-1003
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
        • 接触:
          • David A Ganz, MD PhD MPH
          • 电话号码:40515 (310) 478-3711
          • 邮箱:David.Ganz@va.gov
        • 首席研究员:
          • Jonathan Yahalom, PhD MA
        • 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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Eligible participants include any individual who identifies as a Veteran cisgender man with a history of military sexual trauma (MST), English-speaking, and enrolled in the VA Greater Los Angeles (VAGLA). Participants must:

    • comprehend and sign the informed consent form
    • report a history of military sexual trauma (MST)
    • agree to complete research instruments
  • Because we are looking for a range of impact among men military sexual trauma (MST) survivors, participants will not be excluded based on psychiatric diagnosis

Exclusion Criteria:

  • Per chart review conducted by the PI prior to screening and patient contact, Veterans will be excluded if they demonstrate:

    • severe suicidal or homicidal ideation, defined using the Columbia Suicide Severity Rating Scale (C-SSRS) and behavioral flags per chart review
    • severe and uncontrolled substance abuse (identified through current treatment of a substance use disorder in chart)
    • illness that inhibits engagement in study procedures (e.g., inability to attend in-person visits)
    • inability to self-consent to participate
    • completion of Cognitive Processing Therapy (CPT), Prolonged Exposure (PE) therapy, or the Men's MST Group (MMG) 5 or fewer years ago
    • concurrent enrollment in a trauma-focused intervention
  • Through chart review, Veterans who dropped out of these treatments after 3 sessions will still be eligible as this is considered "early dropout."

  • If immediate clinical attention is warranted, Veterans will receive immediate care via procedures outlined in the human subjects protection plan

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:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Men's MST Group (MMG)

This is a 12-week long group that meets for 90 minutes weekly. This group will draw on interventions, developed in our pilot study, and also based on the PI's previous clinical experience designing and delivering a men's MST Group oriented to reduce psychiatric distress including identity-based shame by promoting group discussion among Veteran men about masculinity, sexuality, belongingness, and emotion regulation. The group is oriented around building core drivers of recovery: 1) agency through exposure- and mindfulness-based interventions to improve distress management; 2) social belongingness through group discussions on gender-specific themes; and 3) hope through coping skill training and treatment experienced as relevant. The protocol will be further revised based on research activity during Aims 1 and 2.

see above

有源比较器:Present-Centered Group Therapy (PCGT)

PCGT is a time-limited treatment for PTSD that focuses on increasing adaptive responses to current life stressors and difficulties that are directly or indirectly related to trauma or PTSD symptoms. PCGT was initially developed as a nonspecific comparison condition to test the effectiveness of trauma-focused cognitive behavioral therapy. The number of PCGT sessions has ranged from 12 to 32 for the group format, and is thus appropriate to utilize for the nature of this study. To minimize possible confounds, PCGT will be delivered for a 12-week period. The basis of PCGT is to provide "common factors" of psychotherapy, demonstrating the effects of what is unique in therapies. In this instance, PCGT may help articulate whether the effect of MMG is due to being gender-specific (bringing men together in the same group therapy setting) or being gender-tailored (delivering treatment that is specifically oriented to men, such as MMG group discussions).

see above

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
The Recovery Assessment Scale
大体时间:up to 9 months

The Recovery Assessment Scale (RAS) is a 41-question forced choice 5-level Likert rating scale, designed to assess recovery, with emphasis on agency, hope, and belongingness, and shame-reduction-key constructs postulated to impact and be expressive of psychological distress and intra- and inter-personal avoidance.The RAS is the most widely used instrument to measure recovery and has good internal consistency, test-retest reliability, and interrater reliability. The scale ranges with a minimum score of 24 and a maximum score of 120; higher values signifying higher recovery.

up to 9 months
External and Internal Shame Scale
大体时间:up to 9 months

External and Internal Shame Scale (EISS) assesses global shame experience, with attention to its external and internal dimensions, relevant to men's MST. The scale consists of eight items, and measures four central shame domains: inferiority/inadequacy, sense of exclusion, uselessness/emptiness and criticism/judgment. This scale is found to have internal consistency and concurrent validity. The scale ranges with a minimum score of 0 and a maximum score of 32; higher values signifying higher levels of shame.

up to 9 months
General Belongingness Scale
大体时间:up to 9 months

General Belongingness Scale (GBS), a 12-item measure rated on a 7-point Likert scale, assesses a general sense of belonging, another indication of interpersonal distress pertaining to MST. This scale is a reliable and valid brief measure of general belongingness, and shows good cross-cultural validity. The scale ranges with a minimum score of 0 and a maximum score of 72; higher values signifying higher levels of belongingness.

up to 9 months

次要结果测量

结果测量
措施说明
大体时间
Post-Traumatic Checklist for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5)
大体时间:up to 9 months

The PCL-5 is a 20-item non-MST specific self-report measure that assesses the DSM-5 symptoms of PTSD, a common indicator of MST-related distress. Each symptom is rated on a 5-point Likert scale assessing distress of each symptom. The PCL-5 has high reliability and validity, and provides a total and cluster symptom severity score corresponding with DSM-5 diagnostic criteria. The scale ranges with a minimum score of 0 and a maximum score of 80; higher values signifying higher levels of post-traumatic stress.

up to 9 months
Patient Health Questionnaire-9
大体时间:up to 9 months

Patient Health Questionnaire-9 (PHQ-9) is a widely used brief, 9-item instrument for screening, diagnosing, monitoring, and measuring the severity of depression over the course of two weeks. The PHQ-9 is a reliable and valid measure of depression severity that assess DSM criteria of depression, including suicidality. PHQ-9 has high cross-cultural validity and is often used in health care research. The scale ranges with a minimum score of 0 and a maximum score of 27; higher values signifying higher levels of depression.

up to 9 months

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。

调查人员

  • 首席研究员:Jonathan Yahalom, PhD MA、VA Greater Los Angeles Healthcare System, West Los Angeles, CA

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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11月13日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2029年12月31日

研究注册日期

首次提交

2024年12月10日

首先提交符合 QC 标准的

2024年12月16日

首次发布 (实际的)

2024年12月18日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • CDX 24-005
  • IK2HX003783-01A2 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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.

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