Do You Really Expect Me to Get MST Care in a VA Where Everyone is Male? Innovative Delivery of Evidence Based Psychotherapy to Women With Military Sexual Trauma (MST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Number of Participants Receiving Prolonged Exposure Treatment via Telemedicine with significantly decreased PTSD symptoms Compared to Number of Participants Receiving Prolonged Exposure Treatment with Standard In-Person Delivery
研究概览
简要总结
The purpose of this study is to determine whether a scientifically validated treatment for Posttraumatic Stress Disorder (PTSD) called Prolonged Exposure (PE) can be delivered effectively to Veterans with Military Sexual Trauma (MST) related PTSD using videoconferencing technology, which allows a therapist and patient who are not in the same room as one another to communicate. The investigators are interested in learning if this form of mental health service delivery is an acceptable alternative to traditional face-to-face therapy delivered with the therapist in the same room as the patient. This study is being conducted at the Charleston VA Medical Center and surrounding Community-Based Outpatient Clinics (CBOCs), and will involve approximately 100 female participants.
详细描述
The purpose of this project is to test, using mixed qualitative and quantitative assessment strategies, the efficacy of PE delivered via home-based telehealth (PE-HBT) versus PE delivered via standard service delivery (PE-SD) using a randomized, between groups, repeated measures design.
Objective 1: To compare, at post, 3 and 6-month follow-up, whether PE-HBT is superior to PE-SD across critical clinical and quality of life outcomes (i.e., PTSD, depression, quality of life) due to increased PE 'dosing' that results from improved session attendance and reduced attrition.
Hypothesis 1: In intent-to-treat analyses, PE-HBT will be more effective than PE-SD at improving clinical and quality of life outcomes at post, 3, and 6-month follow-up; improvement will correlate with session attendance, which will be higher in PE-HBT.
Objective 2: To compare at post-intervention whether PE-HBT is superior to PE-SD across critical process outcomes (e.g., session attendance, satisfaction, and treatment adherence).
Hypothesis 2: PE-HBT will yield better process outcomes than PE-SD post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •MST-related index event
- •Diagnosis of PTSD-related MST
排除标准
- •Having a household member of spouse who is already enrolled in the study
- •Active psychosis or dementia
- •Suicidal and/or homicidal ideation with clear intent
- •Current substance dependence
- •Concurrent enrollment in another clinical trial for PTSD or depression
- •Unwilling to make regular appointments (note that if the participant has medical/transportation barriers that render her unable to make set appointments, this is not grounds for exclusion).
结局指标
主要结局
Number of Participants Receiving Prolonged Exposure Treatment via Telemedicine with significantly decreased PTSD symptoms Compared to Number of Participants Receiving Prolonged Exposure Treatment with Standard In-Person Delivery
时间窗: 36 weeks
次要结局
- Alcohol Use Disorder Identification Test (AUDIT)(36 weeks)
- Sexual Assault Related Mental Contamination Scale (SARA)(36 weeks)
- Index of Functional Impairment (IFI)(36 weeks)
- Treatment Credibility Questionnaire(13 weeks)
- Mini International Neuropsychiatric Interview (M.I.N.I.)(36 weeks)
- Drug Abuse Screening Test (DAST-10)(36 weeks)
- Beck Depression Inventory - II (BDI-II)(36 weeks)
- Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)(36 weeks)
- Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS)(13 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(36 weeks)
- Clinical Administrated PTSD Scale (CAPS)(36 weeks)
- PTSD Checklist, 5th Version (PCL-5)(36 weeks)