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

October 21, 2025 updated by: VA Office of Research and Development
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02130-4817
        • Recruiting
        • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
        • Contact:
        • Principal Investigator:
          • Michelle M Pebole, PhD MA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise
Exercise intervention
Behavioral: Exercise
Adapted with input from phase 1

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility - recruitment interest
Time Frame: through study completion, an average of one year
ratio interested of those approached for the workshop
through study completion, an average of one year
feasibility, enrollment rate
Time Frame: through study completion, an average of one year
Ratio enrolled (consented) of those approached
through study completion, an average of one year
feasibility qualitative via Narrative Evaluation of Intervention Interview
Time Frame: Through study completion, an average of 3 months.
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- Quantitative satisfaction via Client satisfaction questionnaire Change
Time Frame: assessed at BL, 12 weeks, 24 week follow up
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
acceptability - Veteran adherence
Time Frame: Through study completion, an average of one year.
Attendance rate for the 12-week intervention
Through study completion, an average of one year.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Status - The World Health Organization Disability Assessment Schedule 2.0 (WHODAS-2)
Time Frame: baseline, post-intervention (12 weeks), follow up (24 weeks)
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
baseline, post-intervention (12 weeks), follow up (24 weeks)
Physical Function - arm curls
Time Frame: baseline, post-intervention (12 weeks), follow up (24 weeks)
number of curls in 30 seconds
baseline, post-intervention (12 weeks), follow up (24 weeks)
Physical Activity Level - Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time Frame: baseline, post-intervention (12 weeks), follow up (24 weeks)
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.
baseline, post-intervention (12 weeks), follow up (24 weeks)
PTSD - PTSD Checklist-5 (PCL-5) for DSM-V
Time Frame: baseline, post-intervention (12 weeks), follow up (24 weeks)
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
baseline, post-intervention (12 weeks), follow up (24 weeks)
Anxiety - Depression Anxiety and Stress Scale (DASS 21)
Time Frame: baseline, post-intervention (12 weeks), follow up (24 weeks)
Depression Anxiety and Stress Scale (DASS 21) provides scores for depression, anxiety, and stress subscales, with higher scores indicating worse outcomes. Each item is scored on a 4-point scale (0 = Did not apply to me at all, to 3 = Applied to me very much or most of the time)
baseline, post-intervention (12 weeks), follow up (24 weeks)
Depression - Patient Health Questionnaire (PHQ-9)
Time Frame: baseline, post-intervention (12 weeks), follow up (24 weeks)
Will be assessed with the 9-item Patient Health Questionnaire. The total score can range from 0 to 27. Higher scores indicate greater severity of depression.
baseline, post-intervention (12 weeks), follow up (24 weeks)
Psychosocial function- The Brief Inventory of Psychosocial Functioning (IPF-Brief)
Time Frame: baseline, post-intervention (12 weeks), follow up (24 weeks)
Participants rank each of the 7 statements based on their overall experience over the past month on a scale from 0 (not at all) to 6 (very much). 7 is marked if the statement is not applicable. Higher scores indicate more impaired psychosocial functioning.
baseline, post-intervention (12 weeks), follow up (24 weeks)
Pain - Short-Form McGill Pain Questionnaire
Time Frame: baseline, post-intervention (12 weeks), follow up (24 weeks)
Short-Form McGill Pain Questionnaire is an 22-item measure assess pain quality/intensity. Total score ranges from 0-45. Higher scores indicate more severe pain.
baseline, post-intervention (12 weeks), follow up (24 weeks)
Fatigue - Multidimensional Fatigue Inventory (MFI)
Time Frame: baseline, post-intervention (12 weeks), follow up (24 weeks)
is a 20-item instrument that measures dimensions of fatigue. scores range from 20 to 100 with higher scores indicating greater fatigue
baseline, post-intervention (12 weeks), follow up (24 weeks)
Health Status - 12-Item Short Form Health Survey (SF-12)
Time Frame: baseline, post-intervention (12 weeks), follow up (24 weeks)
The 12-Item Short Form Health Survey (SF-12) will be used to assess overall health. Score ranging from 0 to 100. A higher score indicating a better quality of life.
baseline, post-intervention (12 weeks), follow up (24 weeks)
Quality of Life - The Quality of Life Scale (QOLS)
Time Frame: baseline, post-intervention (12 weeks), follow up (24 weeks)
Participants answer each question on a 7 point scale. It is scored by adding up the score on each item to get a minimum potential score of 16 and a maximum total score of 112. Higher scores indicate a higher quality of life.
baseline, post-intervention (12 weeks), follow up (24 weeks)
Exercise Motivation - Behavioral Regulation in Exercise Questionnaire (BREQ-3)
Time Frame: baseline, post-intervention (12 weeks), follow up (24 weeks)
Behavioral Regulation in Exercise Questionnaire (BREQ-3) uses 23 items to measure exercise motivation types, Using a 5 point Likert scale, the maximum score is 5 which indicates a high level of that particular sub-scale of motivation, e.g. intrinsic motivation or amotivation.
baseline, post-intervention (12 weeks), follow up (24 weeks)
Physical function - chair stands
Time Frame: baseline, post-intervention (12 weeks), follow up (24 weeks)
number of chair stands in 30 seconds
baseline, post-intervention (12 weeks), follow up (24 weeks)
physical function - balance
Time Frame: baseline, post-intervention (12 weeks), follow up (24 weeks)
time balancing on one foot
baseline, post-intervention (12 weeks), follow up (24 weeks)
physical function - 2 minute step test
Time Frame: baseline, post-intervention (12 weeks), follow up (24 weeks)
number of knee raised in 2 minutes
baseline, post-intervention (12 weeks), follow up (24 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michelle M Pebole, PhD MA, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D5308-W
  • is 1IK2RX005308-01A1 (Other Grant/Funding Number: VA Rehabilitation Research and Development)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No additional IPD will be shared besides the deidentified/anonymized data set and data dictionary will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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