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Sexual TraumaNCT06741202

Recovery-oriented Group Therapy for Veteran Men With Military Sexual Trauma

A study testing Men's MST Group and Present-Centered Group Therapy in people with Sexual Trauma, run by VA Office of Research and Development at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age, men only
Conditions the study is for
Sexual Trauma
What is being tested?
Men's MST Group and Present-Centered Group Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
5 Oct 2026to 31 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Eligible participants include any individual who identifies as a Veteran cisgender man with a history of MST, English-speaking, 18 years of age or older, and enrolled in the VAGLA. Participants must:
  • comprehend and sign the informed consent form
  • report a history of MST
  • agree to complete research instruments
  • Because we are looking for a range of impact among men MST survivors, participants will not be excluded based on psychiatric diagnosis

Who cannot join

  • 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 CPT, PE, or the MMG 5 or fewer years ago
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jonathan Yahalom, PhD MA contact

(310) 478-3711 ext. 43529

jonathan.yahalom@va.gov

Alison B Hamilton, PhD MPH contact

(310) 478-3711 ext. 44157

Alison.Hamilton@va.gov

United States1 site
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    West Los Angeles, California, 90073-1003

    Elizabeth M Yano, PhD MSPH, (818) 891-7711 ext. 36031, Elizabeth.Yano@va.gov

    David A Ganz, MD PhD MPH, (310) 478-3711 ext. 40515, David.Ganz@va.gov

Other trials in United States

About this study

Official title: Recovery-oriented Group Therapy for Veteran Men With Military Sexual Trauma (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

Read the detailed description

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.

Conditions
Sexual Trauma
Being tested
Men's MST Group, Present-Centered Group Therapy
Keywords
military sexual trauma, veteran men, group therapy
Medical subject headings
Sexual Trauma, Military Sexual Trauma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Men's MST GroupBehavioural

    see above

  • Present-Centered Group TherapyBehavioural

    see above

Study groups in NCT06741202
Study groupRoleWhat they receive
Men's MST Group (MMG)ExperimentalThis 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.
Receives: Behavioral: Men's MST Group
Present-Centered Group Therapy (PCGT)Active comparatorPCGT 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).
Receives: Behavioral: Present-Centered Group Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Recovery Assessment Scale

    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.

    Measured: up to 9 months

  2. External and Internal Shame Scale

    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.

    Measured: up to 9 months

  3. General Belongingness Scale

    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.

    Measured: up to 9 months

Secondary outcomes (2)
  1. Post-Traumatic Checklist for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5)

    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.

    Measured: up to 9 months

  2. Patient Health Questionnaire-9

    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.

    Measured: up to 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2024
  2. Study start5 Oct 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Conduct a pilot randomized controlled trial 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.
Masking
Single blind
Who is masked
Participant
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06741202
Sponsor's protocol ID
CDX 24-005
Other IDs
IK2HX003783-01A2
Status last verified
May 2026
First submitted
10 Dec 2024
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yahalom J, Finley EP, O'Brien S, Yarns BC, Monteith LL, Lang AJ, Hamilton AB. Refining and Assessing Gender-Tailored Group Therapy for Veteran Men With Military Sexual Trauma: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2026 Sep 1;15:e105373. doi: 10.2196/105373.

    PubMed 42679344

Questions about this trial

What is this clinical trial studying?

A study testing Men's MST Group and Present-Centered Group Therapy in people with Sexual Trauma, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jonathan Yahalom, PhD MA ((310) 478-3711 ext. 43529, jonathan.yahalom@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Recovery Assessment Scale (time frame: up to 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06741202, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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