Clinical trial NCT06746740: Developing and Testing a Trauma-Informed Exercise Intervention for Women Veterans With Histories of Sexual Violence
Official title: Developing and Testing a Trauma-Informed Exercise Intervention for Women Veterans With Histories of Sexual Violence
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sexual Violence
Keywords: women Veterans
sexual violence
exercise
transdiagnostic
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-12-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot open trial
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Feasibility - recruitment interest
timeFrame: through study completion, an average of one year
measure: feasibility, enrollment rate
timeFrame: through study completion, an average of one year
measure: feasibility qualitative via Narrative Evaluation of Intervention Interview
timeFrame: Through study completion, an average of 3 months.
measure: acceptability - Veteran adherence
timeFrame: Through study completion, an average of one year.
measure: Acceptability- Quantitative satisfaction via Client satisfaction questionnaire Change
timeFrame: assessed at BL, 12 weeks, 24 week follow up
Secondary outcomes:
measure: Functional Status - The World Health Organization Disability Assessment Schedule 2.0 (WHODAS-2)
timeFrame: baseline, post-intervention (12 weeks), follow up (24 weeks)
measure: Physical Function - arm curls
timeFrame: baseline, post-intervention (12 weeks), follow up (24 weeks)
measure: Physical Activity Level - Godin Leisure-Time Exercise Questionnaire (GLTEQ)
timeFrame: baseline, post-intervention (12 weeks), follow up (24 weeks)
measure: PTSD - PTSD Checklist-5 (PCL-5) for DSM-V
timeFrame: baseline, post-intervention (12 weeks), follow up (24 weeks)
measure: Anxiety - Depression Anxiety and Stress Scale (DASS 21)
timeFrame: baseline, post-intervention (12 weeks), follow up (24 weeks)
measure: Depression - Patient Health Questionnaire (PHQ-9)
timeFrame: baseline, post-intervention (12 weeks), follow up (24 weeks)
measure: Psychosocial function- The Brief Inventory of Psychosocial Functioning (IPF-Brief)
timeFrame: baseline, post-intervention (12 weeks), follow up (24 weeks)
measure: Pain - Short-Form McGill Pain Questionnaire
timeFrame: baseline, post-intervention (12 weeks), follow up (24 weeks)
measure: Fatigue - Multidimensional Fatigue Inventory (MFI)
timeFrame: baseline, post-intervention (12 weeks), follow up (24 weeks)
measure: Health Status - 12-Item Short Form Health Survey (SF-12)
timeFrame: baseline, post-intervention (12 weeks), follow up (24 weeks)
measure: Quality of Life - The Quality of Life Scale (QOLS)
timeFrame: baseline, post-intervention (12 weeks), follow up (24 weeks)
measure: Exercise Motivation - Behavioral Regulation in Exercise Questionnaire (BREQ-3)
timeFrame: baseline, post-intervention (12 weeks), follow up (24 weeks)
measure: Physical function - chair stands
timeFrame: baseline, post-intervention (12 weeks), follow up (24 weeks)
measure: physical function - balance
timeFrame: baseline, post-intervention (12 weeks), follow up (24 weeks)
measure: physical function - 2 minute step test
timeFrame: baseline, post-intervention (12 weeks), follow up (24 weeks)
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Michelle M Pebole, PhD MA
role: PRINCIPAL_INVESTIGATOR
References: