Developing and Testing a Trauma-Informed Exercise Intervention for Women Veterans With Histories of Sexual Violence

VA Office of Research and Development

Status

Enrolling

Conditions

Sexual Violence

Treatments

Behavioral: Exercise

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT06746740

is 1IK2RX005308-01A1 (Other Grant/Funding Number)

D5308-W

Details and patient eligibility

About

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.

Full description

Women Veterans (WVs) disproportionately experience sexual violence (SV) throughout their lifetime. These experiences of SV are often repeated, resulting in a lifelong pattern of SV victimization which can have profound negative impacts on physical, mental, and psychosocial functioning and quality of life. Current VHA policies highlight the need for integrative interventions which effectively address the diverse negative health sequelae associated with lifetime SV. Yet, there is currently a gap in treatment offerings that address broad psychiatric, physical, and psychosocial health impacts of SV. Exercise has been shown to improve trauma-related mental health conditions among survivors of SV and improve trauma-related multimorbidity among Veterans with a PTSD diagnosis. Yet, many barriers exist to exercise among WVs which contribute to low exercise engagement from this group. This Career Development Award (CDA-2) thus aims to develop and test a trauma-informed telehealth exercise intervention tailored for WVs with histories of SV. Treatment development will be guided by 1) previous interventions completed among Veterans with PTSD, 2) documented preferences among women with histories of SV, and 3) trauma-informed approaches and integration of stakeholder feedback. During phase one of this project, the investigators will conduct pre-implementation stakeholder interviews with WVs with histories of SV and related healthcare providers to provide guidance on the structure and content of the proposed intervention. This information will be used to create the program manual for the proposed intervention. During phase two of this project, WVs aged 21-65 with lifetime history of SV will be recruited to participate in an open trial consisting of a 12-week, online physical activity program including aerobic and strength training. Qualitative data will be collected in parallel with quantitative outcomes to assesses the primary feasibility and acceptability outcomes. Exploratory outcomes will include functional status. Candidate outcomes to be assessed include physical, mental, and psychosocial health outcomes. This pilot trail will extend the understanding for trauma-informed exercise approaches for WVs with histories of SV and of the feasibility, acceptability, and potential benefits of exercise for this group. Results will be used to develop a fully powered randomized controlled trial for WVs with histories of SV.

Enrollment

40 estimated patients

Sex

Female

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

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