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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2030-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Physical Exercise Versus Group Therapy on Self-esteem Among Domestic Violence Victims

NCT04875494

Domestic Violence

COMPLETED NA

Addressing Intimate Partner Violence Among Women Veterans

NCT04106193

Intimate Partner Violence

COMPLETED NA

Treatments for Improving Mood in Women Survivors of Interpersonal Violence: A Community-Engaged Study-1.2

NCT06657950

Distress

COMPLETED NA

Body-Oriented Therapy for Sexual Abuse Recovery

NCT00097305

Child Abuse, Sexual Post-Traumatic Stress Disorder Dissociation

COMPLETED PHASE2

Therapeutic Exercise on the Psychological Well-being of Women Victims of Gender Violence.

NCT05981417

Anxiety Disorders Depressive Symptoms Gender-based Violence

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sexual Violence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot open trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exercise

Exercise intervention

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Adapted with input from phase 1

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise

Adapted with input from phase 1

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes