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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-65
SponsorVA Office of Research and Development

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Veteran self-identifies as woman

has a history of sexual violence at any point in their lifetime

currently does not meet physical activity level guidelines

reports some functional difficulties that indicate some interference in daily life

Disqualifiers

does not identify a safe and private location for exercise participation

severe drug or alcohol use disorder within the past year

neurological disorder

systemic illness affecting central nervous system function

Trial design

Design model

Single group

Treatments tested in this trial

  • Exercise

    Behavioral

    Adapted with input from phase 1

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: ExerciseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility - recruitment interest

ratio interested of those approached for the workshop

Time frame
through study completion, an average of one year
2

feasibility, enrollment rate

Ratio enrolled (consented) of those approached

Time frame
through study completion, an average of one year
3

feasibility qualitative via Narrative Evaluation of Intervention Interview

Identification of challenges and facilitators during the recruitment process as assessed by study staff as well as feedback from focus group participants generated using the Narrative Evaluation of Intervention Interview (NEII). This is an interview composed of 16 open ended questions that allows participants to evaluate the process and outcomes of the intervention. Reviewers will generate a list of themes based on the responses to this interview.

Time frame
Through study completion, an average of 3 months.
4

acceptability - Veteran adherence

Attendance rate for the 12-week intervention

Time frame
Through study completion, an average of one year.

Secondary outcomes

1

Functional Status - The World Health Organization Disability Assessment Schedule 2.0 (WHODAS-2)

The World Health Organization Disability Assessment Schedule 2.0 (WHODAS-2) is a 36-item self-report tool that assesses functioning in the past 30 days among six specific domains (i.e., cognition, physical mobility, self-care, social, domestic/occupational, and participation in society) and provides an overall disability score. Higher scores indicate greater disability

Time frame
baseline, post-intervention (12 weeks), follow up (24 weeks)
2

Physical Function - arm curls

number of curls in 30 seconds

Time frame
baseline, post-intervention (12 weeks), follow up (24 weeks)
3

Physical Activity Level - Godin Leisure-Time Exercise Questionnaire (GLTEQ)

The Godin Leisure-Time Exercise Questionnaire (GLTEQ) is a validated brief inventory assessing activity domains and aerobic activity in a typical week. Duration in minutes of exercise multiplied by number of times per week, in the past 7 days. Total minutes per week calculated; mean reported.

Time frame
baseline, post-intervention (12 weeks), follow up (24 weeks)
4

PTSD - PTSD Checklist-5 (PCL-5) for DSM-V

The PTSD Checklist-5 (PCL-5) for DSM-V is a 20-item self-report measure that assesses the extent to which an individual is bothered by each PTSD symptom during the past month using a 5-point Likert-type scale. Higher scores indicating more severe symptoms

Time frame
baseline, post-intervention (12 weeks), follow up (24 weeks)

Other outcomes

Sponsors and contacts

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