Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care (I-STEP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Posttraumatic Stress Disorder Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5)
研究概览
简要总结
A majority of residents in low income communities have been exposed to a potentially traumatic event, and up to half (30-50%) of trauma-exposed residents in safety net clinical settings meet criteria for posttraumatic stress disorder (PTSD). Despite this, only 13% receive treatment. Poor access to PTSD treatment is due to a shortage of mental health specialists.
This study aims to evaluate the implementation and effectiveness of a brief, cognitive-behavioral intervention for posttraumatic stress disorder (PTSD)-Skills Training in Affective and Interpersonal Regulation (STAIR)- that will be offered in Boston Medical Center (BMC)'s primary care clinics as the new standard of care following integrated behavioral healthcare (IBH) therapist training. In response to clinician capacity concerns and the impact of the COVID-19 pandemic, we will be offering the intervention in both clinician-administered and self-paced, web-administered formats. The evidence base suggests that STAIR, delivered both synchronously (in-person/telehealth STAIR) and asynchronously (webSTAIR), is associated with significant improvements in PTSD and depression symptoms.
详细描述
Participants who enroll in the study will be randomized to either in-person/telehealth STAIR or webSTAIR. Those who do not enroll in the study will still be able to receive STAIR in person or via telehealth as part of usual care.
Participant data will be for 9 months. Treatment plans will continue to be determined by usual care providers, the study has no involvement in any decisions regarding care. This means that a participant's IBH therapist can continue the therapy, offer a different treatment option, or refer to other services at any time in the study and after the study is completed. At any time, patients can also choose to change their treatment plans, for example from webSTAIR to in-person/telehealth STAIR, or to another treatment option in the clinic. Access to webSTAIR will be discontinued at 9 months.
The investigators hypothesize that offering a low intensity treatment for PTSD through primary care will improve access to and engagement in care for PTSD among BMC's patient population. The feasibility of two modes of treatment delivery will be compared, while gathering further evidence of the effectiveness of the intervention in our local setting. It is also hypothesized that both formats will be effective in reducing mental health symptoms, while webSTAIR may have some advantages in regard to uptake and long-term sustainability in usual care.
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
- 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
- •Client seen in integrated behavioral health in Boston Medical Center's General Internal Medicine and Family Medicine clinics.
- •Able to receive therapy in English (per participant report)
- •Exposure to trauma (as indicated by Life Events Checklist (LEC) for the Diagnostic and Statistical Manual of Mental Disorders (DSM) DSM-5 [LEC-5])
- •Subthreshold or Full Criteria for PTSD (as indicated by the PTSD Checklist Posttraumatic Stress Disorder Checklist (PCL) for the DSM-5 [PCL-5])
- •Reasonable to access to technology needed to support either condition (e.g., phone, computer, internet access).
排除标准
- •Patient is not appropriate for outpatient level of care / standard of care provided in Integrated behavioral health (IBH) per clinician judgement
- •Currently receiving cognitive behavioral therapy for PTSD elsewhere e.g., cognitive processing theory (CPT), prolonged exposure (PE), eye movement desensitization and reprocessing (EMDR).
- •Patient is experiencing bereavement (death of someone close) as primary clinical concern, and is therefore not a good fit for a PTSD-specific treatment at this time.
研究组 & 干预措施
STAIR-PC Group
Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.
干预措施: STAIR-PC Group (Behavioral)
WebSTAIR Group
Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.
干预措施: WebSTAIR Group (Behavioral)
结局指标
主要结局
Posttraumatic Stress Disorder Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5)
时间窗: Baseline, 15 weeks, and 9 months
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms. The PCL-5 scale ranges from Not At All (0) to Extremely (4) so the PTSD checklist total scores can range from 0 to 80, where higher scores indicate higher severity of PTSD symptoms.
Feasibility Based on Retention
时间窗: 15 weeks
The number of participants who completed at least 90 minutes of an intervention by 15 weeks
Acceptability Measured by Client Satisfaction Questionnaire (CSQ-8)
时间窗: 15 weeks, 9 months
The Client Satisfaction Questionnaire (CSQ-8) is an 8-item survey to measure and assess consumer satisfaction with health and human services. Response options differ for each item, the scale ranges from very negative response (1) to a very positive response (4), and the total range for the CSQ-8 can be from 1 to 32 with higher scores indicating higher satisfaction.
次要结局
- General Mental Health Functioning Measured by the Brief Symptom Inventory (BSI-18)(Baseline, 15 weeks, 9 months)
- Emotional Regulation Measured by the Difficulties in Emotion Regulation Scale (DERS)(Baseline, 15 weeks, 9 months)
- Trauma Symptoms as Assessed by the Trauma Symptoms of Discrimination Scale (TSDS) of Discrimination Scale,(Baseline, 15 weeks, 9 months)
- Social Functioning Measured by the Interpersonal Support Evaluation List - 12-item Version (ISEL-12)(Baseline, 15 weeks, 9 months)