Sexual ViolenceNCT06746740
Developing and Testing a Trauma-Informed Exercise Intervention for Women Veterans With Histories of Sexual Violence
A study testing Exercise in people with Sexual Violence, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Violence
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2025to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- safe and private location to engage in the virtual exercise program
Who cannot join
- 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
Show all 15Show fewer
- 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 cardiovascular disease (CVD)
- metabolic
- renal disease
- if taking antidepressants must have stable regimen
- if in psychotherapy maintain therapy throughout trial
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
Michelle M Pebole, PhD MA, (857) 364-4989, michelle.pebole@va.gov
Michelle M Pebole, PhD MA
- Recruiting
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
Michelle M Pebole, (85-7) -4989, Michelle.Pebole@va.gov
About this study
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.
Read the 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.
- Conditions
- Sexual Violence
- Being tested
- Exercise
- Keywords
- women Veterans, sexual violence, exercise, transdiagnostic
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Adapted with input from phase 1
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercise intervention Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - recruitment interest
ratio interested of those approached for the workshop
Measured: through study completion, an average of one year
feasibility, enrollment rate
Ratio enrolled (consented) of those approached
Measured: 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.
Measured: Through study completion, an average of 3 months.
acceptability - Veteran adherence
Attendance rate for the 12-week intervention
Measured: 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.
Measured: 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)
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
Measured: baseline, post-intervention (12 weeks), follow up (24 weeks)
Physical Function - arm curls
number of curls in 30 seconds
Measured: baseline, post-intervention (12 weeks), follow up (24 weeks)
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.
Measured: baseline, post-intervention (12 weeks), follow up (24 weeks)
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
Measured: baseline, post-intervention (12 weeks), follow up (24 weeks)
Anxiety - Depression Anxiety and Stress Scale (DASS 21)
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)
Measured: baseline, post-intervention (12 weeks), follow up (24 weeks)
Depression - Patient Health Questionnaire (PHQ-9)
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.
Measured: baseline, post-intervention (12 weeks), follow up (24 weeks)
Psychosocial function- The Brief Inventory of Psychosocial Functioning (IPF-Brief)
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.
Measured: baseline, post-intervention (12 weeks), follow up (24 weeks)
Pain - Short-Form McGill Pain Questionnaire
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.
Measured: baseline, post-intervention (12 weeks), follow up (24 weeks)
Fatigue - Multidimensional Fatigue Inventory (MFI)
is a 20-item instrument that measures dimensions of fatigue. scores range from 20 to 100 with higher scores indicating greater fatigue
Measured: baseline, post-intervention (12 weeks), follow up (24 weeks)
Health Status - 12-Item Short Form Health Survey (SF-12)
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.
Measured: baseline, post-intervention (12 weeks), follow up (24 weeks)
Quality of Life - The Quality of Life Scale (QOLS)
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.
Measured: baseline, post-intervention (12 weeks), follow up (24 weeks)
Exercise Motivation - Behavioral Regulation in Exercise Questionnaire (BREQ-3)
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.
Measured: baseline, post-intervention (12 weeks), follow up (24 weeks)
Physical function - chair stands
number of chair stands in 30 seconds
Measured: baseline, post-intervention (12 weeks), follow up (24 weeks)
physical function - balance
time balancing on one foot
Measured: baseline, post-intervention (12 weeks), follow up (24 weeks)
physical function - 2 minute step test
number of knee raised in 2 minutes
Measured: baseline, post-intervention (12 weeks), follow up (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Oct 2025
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual ViolenceStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot open trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Michelle M Pebole, PhD MA, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746740
- Sponsor's protocol ID
- D5308-W
- Other IDs
- IK2RX005308
- Status last verified
- Oct 2026
- First submitted
- 18 Dec 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No additional IPD will be shared besides the deidentified/anonymized data set and data dictionary will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Trauma-Informed Exercise Intervention for Women Veterans With Histories of Sexual Violence
- ClinicalTrials.gov ID
- NCT06746740
- Acronym / sponsor ID
- D5308-W
- Conditions
- Sexual Violence
- Keywords
- women Veterans, sexual violence, exercise, transdiagnostic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot open trial
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseExercise intervention |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- safe and private location to engage in the virtual exercise program
Key exclusion criteria (15 listed)
- does not identify a safe and private location for exercise participation
- severe drug or alcohol use disorder within the past year
- clinically significant:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAdapted with input from phase 1 | Behavioural | Exercise |
Primary outcome
Feasibility - recruitment interest
Time frame: through study completion, an average of one year
ratio interested of those approached for the workshop
feasibility, enrollment rate
Time frame: through study completion, an average of one year
Ratio enrolled (consented) of those approached
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.
acceptability - Veteran adherence
Time frame: Through study completion, an average of one year.
Attendance rate for the 12-week intervention
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.
15 secondary outcomes
Functional Status - The World Health Organization Disability Assessment Schedule 2.0 (WHODAS-2)
Time frame: baseline, post-intervention (12 weeks), follow up (24 weeks)
Physical Function - arm curls
Time frame: 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)
PTSD - PTSD Checklist-5 (PCL-5) for DSM-V
Time frame: 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 - Patient Health Questionnaire (PHQ-9)
Time frame: 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)
Pain - Short-Form McGill Pain Questionnaire
Time frame: 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)
Health Status - 12-Item Short Form Health Survey (SF-12)
Time frame: 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)
Exercise Motivation - Behavioral Regulation in Exercise Questionnaire (BREQ-3)
Time frame: baseline, post-intervention (12 weeks), follow up (24 weeks)
Physical function - chair stands
Time frame: baseline, post-intervention (12 weeks), follow up (24 weeks)
physical function - balance
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. No additional IPD will be shared besides the deidentified/anonymized data set and data dictionary will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle M Pebole, PhD MA principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Sexual Violence, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle M Pebole, PhD MA ((857) 364-4989, michelle.pebole@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - recruitment interest (time frame: through study completion, an average of one year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.