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

NCT06741202 | Not Yet Recruiting

• 2 other identifiers: CDX 24-005IK2HX003783-01A2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Sexual Trauma

Keywords

military sexual trauma; veteran men; group therapy

Outcome Measures

Primary Outcomes (3)

• 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.

  up to 9 months

• 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.

  up to 9 months

• 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.

  up to 9 months

Secondary Outcomes (2)

• Post-Traumatic Checklist for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5)

  up to 9 months

• Patient Health Questionnaire-9

  up to 9 months

Study Arms (2)

Men's MST Group (MMG)

EXPERIMENTAL

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.

Behavioral: Men's MST Group

Present-Centered Group Therapy (PCGT)

ACTIVE COMPARATOR

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).

Behavioral: Present-Centered Group Therapy

Interventions

Men's MST Group BEHAVIORAL

see above

Men's MST Group (MMG)

Present-Centered Group Therapy BEHAVIORAL

see above

Present-Centered Group Therapy (PCGT)

Eligibility Criteria

• Gender Eligibility Details: this is a study on men's MST
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003, United States

Location

MeSH Terms

Conditions

Sexual Trauma; Military Sexual Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jonathan Yahalom, PhD MA

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Yahalom, PhD MA

CONTACT

(310) 478-3711; jonathan.yahalom@va.gov

Alison B Hamilton, PhD MPH

CONTACT

(310) 478-3711; Alison.Hamilton@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be allocated to either MMG or PCGT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 18, 2024
• Study Start (Estimated): October 5, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)