Screening & TReatment fOr Perinatal WomeN With PTSD in Substance Use Care SettinGs in Arkansas (STRONG Moms)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
The goal of this study is to examine the feasibility and acceptability of providing Written Exposure Therapy (WET), a brief, evidence-based therapy for post-traumatic stress disorder (PTSD) via tele-health to pregnant and postpartum individuals receiving services for problematic substance misuse in Arkansas.
详细描述
The primary objective is to evaluate the feasibility and acceptability of implementing a brief, telehealth-delivered behavioral intervention for PTSD among pregnant and postpartum individuals with a history of substance misuse. Secondary objectives include estimating the prevalence of probable PTSD in perinatal substance use treatment settings, assessing participant interest in receiving PTSD treatment while engaged in substance use care, and examining preliminary changes in PTSD and depressive symptoms following treatment.
The study consists of two sequential components. First, pregnant and postpartum individuals receiving services for problematic substance misuse in Arkansas will be screened for PTSD symptoms using the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5). Screening will be conducted across multiple treatment and care settings, including inpatient and outpatient programs, to estimate the prevalence of probable PTSD and characterize willingness to participate in trauma-focused treatment during the perinatal period.
Second, individuals who meet eligibility criteria for PTSD treatment will participate in a mixed-methods, single-arm pre-post pilot evaluation of Written Exposure Therapy (WET), a brief evidence-based behavioral intervention for PTSD delivered via telehealth. Approximately 20 pregnant and postpartum participants with PTSD will receive the intervention. Feasibility will be assessed through measures such as recruitment, enrollment, retention, intervention completion, and assessment completion. Acceptability will be evaluated using participant-reported satisfaction and qualitative interviews exploring experiences with treatment delivery, barriers and facilitators to participation, and recommendations for implementation. Clinical assessments conducted before and after treatment will provide preliminary estimates of changes in PTSD symptoms and depressive symptoms.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to write, understand, and speak English
- •Able to give informed consent
- •Currently pregnant or postpartum (≤ 6 months after childbirth)
- •History of substance misuse
- •Receiving services for substance-use related problems
- •Have a history of traumatic event exposure
- •Endorse clinically significant PTSD symptoms (score ≥ 3 on the Primary Care PTSD Screen for DSM-5; PC-PTSD-5)
排除标准
- •Unwilling to provide consent
- •No history of Criterion A trauma exposure or clinically significant PTSD symptoms
- •No history of substance misuse or currently receiving services for a substance-use related problem
研究组 & 干预措施
Single Arm Intervention
All participants will receive Written Exposure Therapy (WET)
干预措施: Written Exposure Therapy (WET) (Behavioral)
结局指标
主要结局
Acceptability
时间窗: From baseline to end of treatment at 5 weeks
Acceptability will be evaluated using the Client Satisfaction Questionnaire (CSQ-8), an 8-item participant-reported satisfaction measure rated on a 4-point Likert scale. Total scores ranging from 8-32, with higher scores indicating greater satisfaction with the therapy.
Feasibility of Recruitment
时间窗: From enrollment to end of treatment at 5 weeks
Feasibility of recruitment will be assessed by the number of individuals who initiated WET versus the total number of individuals enrolled in the study.
Therapy Adherence
时间窗: From enrollment to end of treatment at 5 weeks
Therapy adherence will be assessed by WET session attendance and completion. We will measure therapy adherence by the number of individuals who complete ≥ 4 sessions versus the total number of individuals who received ≤ 3 sessions.
次要结局
- PTSD Symptoms(From enrollment to the end of treatment at 5 weeks)
- Depression Symptoms(From enrollment to end of treatment at 5 weeks)
- Substance Use Severity(From enrollment to end of treatment at 5 weeks)
- Pre/Postnatal Depression Symptoms(From enrollment to the end of treatment at 5 weeks)