Developing and Testing a Trauma-Informed Exercise Intervention for Women Veterans With Histories of Sexual Violence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility - recruitment interest
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Exercise
Exercise intervention
干预措施: Exercise (Behavioral)
结局指标
主要结局
Feasibility - recruitment interest
时间窗: through study completion, an average of one year
ratio interested of those approached for the workshop
feasibility, enrollment rate
时间窗: through study completion, an average of one year
Ratio enrolled (consented) of those approached
feasibility qualitative via Narrative Evaluation of Intervention Interview
时间窗: 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
时间窗: Through study completion, an average of one year.
Attendance rate for the 12-week intervention
Acceptability- Quantitative satisfaction via Client satisfaction questionnaire Change
时间窗: 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.
次要结局
- 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))
- Depression - Patient Health Questionnaire (PHQ-9)(baseline, post-intervention (12 weeks), follow up (24 weeks))
- Psychosocial function- The Brief Inventory of Psychosocial Functioning (IPF-Brief)(baseline, post-intervention (12 weeks), follow up (24 weeks))
- Pain - Short-Form McGill Pain Questionnaire(baseline, post-intervention (12 weeks), follow up (24 weeks))
- Fatigue - Multidimensional Fatigue Inventory (MFI)(baseline, post-intervention (12 weeks), follow up (24 weeks))
- Health Status - 12-Item Short Form Health Survey (SF-12)(baseline, post-intervention (12 weeks), follow up (24 weeks))
- Quality of Life - The Quality of Life Scale (QOLS)(baseline, post-intervention (12 weeks), follow up (24 weeks))
- Exercise Motivation - Behavioral Regulation in Exercise Questionnaire (BREQ-3)(baseline, post-intervention (12 weeks), follow up (24 weeks))
- Physical function - chair stands(baseline, post-intervention (12 weeks), follow up (24 weeks))
- physical function - balance(baseline, post-intervention (12 weeks), follow up (24 weeks))
- physical function - 2 minute step test(baseline, post-intervention (12 weeks), follow up (24 weeks))