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

NCT06746740 | Recruiting

• 2 other identifiers: D5308-Wis 1IK2RX005308-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Violence

Keywords

women Veterans; sexual violence; exercise; transdiagnostic

Outcome Measures

Primary Outcomes (5)

• Feasibility - recruitment interest

  ratio interested of those approached for the workshop

  through study completion, an average of one year

• feasibility, enrollment rate

  Ratio enrolled (consented) of those approached

  through study completion, an average of one year

• 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.

  Through study completion, an average of 3 months.

• acceptability - Veteran adherence

  Attendance rate for the 12-week intervention

  Through study completion, an average of one year.

• Acceptability- Quantitative satisfaction via Client satisfaction questionnaire Change

  Client satisfaction questionnaire (CSQ-8), total scores range from 8 to 32 with higher scores indicating higher satisfaction.

  assessed at BL, 12 weeks, 24 week follow up

Secondary Outcomes (15)

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

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

• Physical Function - arm curls

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

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

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

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

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

• Anxiety - Depression Anxiety and Stress Scale (DASS 21)

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

Study Arms (1)

Exercise

EXPERIMENTAL

Exercise intervention

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Adapted with input from phase 1

Exercise

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: self-identifies as woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michelle M Pebole, PhD MA

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle M Pebole, PhD MA

CONTACT

(857) 364-4989; michelle.pebole@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Pilot open trial

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)