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군 성적 트라우마가 있는 퇴역군인을 위한 회복 중심 그룹 치료

2026년 11월 4일 업데이트: VA Office of Research and Development

군 성적 트라우마가 있는 퇴역군인을 위한 회복 중심 그룹 치료(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

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

32

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • California
      • West Los Angeles, California, 미국, 90073-1003
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
        • 연락하다:
          • David A Ganz, MD PhD MPH
          • 전화번호: 40515 (310) 478-3711
          • 이메일: David.Ganz@va.gov
        • 수석 연구원:
          • Jonathan Yahalom, PhD MA
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

남성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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

활성 비교기: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The Recovery Assessment Scale
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Post-Traumatic Checklist for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5)
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Jonathan Yahalom, PhD MA, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 11월 13일

기본 완료 (추정된)

2028년 12월 31일

연구 완료 (추정된)

2029년 12월 31일

연구 등록 날짜

최초 제출

2024년 12월 10일

QC 기준을 충족하는 최초 제출

2024년 12월 16일

처음 게시됨 (실제)

2024년 12월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 4일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • CDX 24-005
  • IK2HX003783-01A2 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .