Increasing Access to Evidenced-Based PTSD Treatment in the Military: Behavioral Health Technician Delivered Written Exposure Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Clinician Administered PTSD Scale (CAPS-5)
研究概览
简要总结
This study has two main goals. First, it aims to test a treatment called written exposure therapy to see if it can help military service members who have posttraumatic stress disorder (PTSD). Second, it aims to test a new way of making this therapy more accessible in military clinics by utilizing task-sharing with Behavioral Health Technicians (BHTs). PTSD is a common and serious issue among service members. Written exposure therapy (WET) has been proven to be effective for improving PTSD that requires five therapy sessions delivered weekly. This study aims to determine:
- How well does written exposure therapy help to reduce symptoms of posttraumatic stress for service members with PTSD?
- Is sharing the therapy tasks with behavioral health technicians is a helpful approach for managing behavioral health clinic patient volume and improving patient outcomes?
We plan to recruit a total of 40-59 staff participants, as well as 150 active-duty patient participants with PTSD. We will randomize patient participants to one of two treatment conditions: 1) treatment-as-usual (TAU) or 2) TAU and 5 sessions of WET. Staff and participants will be recruited from two military treatment facilities: 1) Fort Sam Houston in San Antonio (Brooke Army Medical Center) and 2) Camp Pendleton (Naval Hospital at Camp Pendleton).
Consented patient participants will:
- Complete a PTSD interview via telehealth with a study team member to determine if you are eligible for the study
- Be randomly assigned to one of the following conditions: 1) TAU + WET or 2) TAU
- Complete up to 8 weeks of behavioral health treatment (either TAU + WET or TAU)
- Complete self-report measures before, during, and after treatment, and at a 3- and 6-month follow up assessment after the treatment period
- Complete a posttreatment PTSD interview via telehealth with a study team member
- A subset of participants will be asked to complete a brief treatment experience interview posttreatment
Consented staff participants will:
- Participate in an interview about your perceptions of and experiences supporting BHT-delivered WET with a study team member at the VAPAHCS
- A subset of participants will also be asked to participate in a brief staff feedback interview approximately 6 months after their first interview
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient participants:
- •Adult active duty personnel ages ≥18
- •Clinically significant PTSD symptoms (CAPS-5 ≥ 25).
- •Clinic staff participants: Individuals working as BHTs, clinic providers, and clinic leaders working at the behavioral health clinics participating in the study
排除标准
- •Patient participants:
- •Current suicide or homicide risk meriting crisis intervention
- •Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate attention
- •Inability to comprehend the baseline screening questionnaires
- •Definite plans to leave the military within 10 weeks
- •Clinic staff participants:
结局指标
主要结局
Clinician Administered PTSD Scale (CAPS-5)
时间窗: Change from baseline to immediately post treatment
The CAPS-5 is a 30-item structured clinical interview that assesses the presence and severity of 20 PTSD symptoms as defined by the DSM-5. It also assess the impact of these symptoms on daily functioning and will be used to evaluate if there is a response to the experimental treatment in this study.
次要结局
- Posttraumatic Stress Disorder Checklist (PCL-5)(Change from baseline through 6 months post treatment)
- Insomnia Severity Index (ISI)(Change from baseline through 6 months post treatment)
- Generalized Anxiety Disorder 7-Item (GAD-7) Scale(Change from baseline through 6 months post treatment)
- Patient Health Questionnaire-9 (PHQ-9)(Change from baseline through 6 months post treatment)
- Life Events Checklist for DSM-5 (LEC-5)(Baseline)
- Depressive Symptoms Index-Suicidality Subscale (DSI-SS).(Change from baseline through 6 months post treatment)
- History of Head Injuries(Baseline)
- Brief Inventory of Psychosocial Functioning (B-IPF).(Changes from baseline through 6 months post treatment)
- Credibility/Expectancy Questionnaire (CEQ)(Immediately after the first treatment session, and immediately after the final treatment session)
- Net Prompter Score(Post treatment (~6 months post baseline))
- Patient Satisfaction Survey(Post treatment (~6 months post baseline))
- Treatment Engagement(Through study completion, an average of 2 years)
- WET Adoption(Through study completion, an average of 2 years)
- WET Fidelity(Through study completion, an average of 2 years)
- Demographics and Military Service Characteristics Form(Baseline.)