NCT06746740 Developing and Testing a Trauma-Informed Exercise Intervention for Women Veterans With Histories of Sexual Violence
| NCT ID | NCT06746740 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Sexual Violence |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2030-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-10-01 with a primary completion date of 2030-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Exposure to sexual violence disproportionally impacts women Veterans and can have profound negative impacts on daily functioning. Current treatments for sexual violence focus on psychiatric symptoms and ignore frequently co-occurring physical and psychosocial concerns. Exercise can improve trauma-related physical, mental, and psychosocial health conditions and may help women who have experienced sexual violence. Yet, women Veterans experience many barriers to participating in exercise and prefer interventions that are tailored to their preferences. This proposal will develop and test an exercise intervention tailored specifically to women Veterans who have experienced sexual violence. Treatment development will be informed by women Veterans with histories of sexual violence and their providers. Feasibility and acceptability will be tested, and outcomes will be explored to inform future research. This intervention is urgently needed to address gaps in integrative care and persistent trauma-related health concerns among women Veterans with histories of sexual violence.
Eligibility Criteria
Inclusion Criteria: * Veteran self-identifies as woman * has a history of sexual violence at any point in their lifetime * between the ages of 21 an 65 * currently does not meet physical activity level guidelines * reports some functional difficulties that indicate some interference in daily life * safe and private location to engage in the virtual exercise program Exclusion Criteria: * does not identify a safe and private location for exercise participation * severe drug or alcohol use disorder within the past year * clinically significant: * neurological disorder * systemic illness affecting central nervous system function * history of seizure disorder in the past 5 years * uncontrolled diabetes * end stage liver disease or currently receiving dialysis * physical disabilities precluding use of exercise equipment * significant cognitive impairment * active signs and symptoms of CVD * metabolic * renal disease * if taking antidepressants must have stable regimen * if in psychotherapy maintain therapy throughout trial
Contact & Investigator
Michelle M Pebole, PhD MA
PRINCIPAL INVESTIGATOR
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Frequently Asked Questions
Who can join the NCT06746740 clinical trial?
This trial is open to female participants only, aged 21 Years or older, up to 65 Years, studying Sexual Violence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06746740 currently recruiting?
Yes, NCT06746740 is actively recruiting participants. Contact the research team at michelle.pebole@va.gov for enrollment information.
Where is the NCT06746740 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06746740 clinical trial?
NCT06746740 is sponsored by VA Office of Research and Development. The principal investigator is Michelle M Pebole, PhD MA at VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA. The trial plans to enroll 40 participants.