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Recruiting NCT06746740

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

No phase Interventional Sexual Violence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise.
Who it may be relevant to
Registry conditions: Sexual Violence. Basic parameters: 21 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Exercise
    Adapted with input from phase 1

Primary outcome measures

  • Feasibility - recruitment interest [Time frame: through study completion, an average of one year]
  • feasibility, enrollment rate [Time frame: 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.]
  • acceptability - Veteran adherence [Time frame: Through study completion, an average of one year.]
  • Acceptability- Quantitative satisfaction via Client satisfaction questionnaire Change [Time frame: assessed at BL, 12 weeks, 24 week follow up]
Secondary outcome measures (12)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston

Identifiers

NCT: NCT06746740 · D5308-W · is 1IK2RX005308-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗