Online Early Resilience Intervention for Combat-Related PTSD in Military Primary Healthcare Settings: A Randomized Trial of "DESTRESS-PC"
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 8
- 主要终点
- PTSD Checklist (PCL)
研究概览
简要总结
This study will compare a cognitive-behavioral online self-management intervention designed for primary care treatment of war-related PTSD to a control intervention, "optimized usual primary care PTSD treatment". Patients with PTSD will be trained to use the online PTSD treatment website and asked to do so three times per week for six weeks. They will have phone and email access to a nurse trained to assist them in their treatment program. Three scheduled phone check-ins during the six week treatment period will provide ongoing contact with patients during treatment. The investigators will assess PTSD symptoms, depression, anxiety and somatic symptoms, physical health status and occupational functioning on three occasions: before the intervention, at the end of the treatment period, and six weeks after the end of treatment.
详细描述
The study is a multi-site trial evaluating the efficacy of DESTRESS-PC (DElivery of Self-TRaining and Education for Stressful Situations, primary care version), a brief, web-based self-management intervention for PTSD designed for delivery in primary care. Participants randomized to DESTRESS-PC log on to a secure website for self-CBT 3 times per week for 6 weeks and receive RN nurse care manager ("DESTRESS Nurse") contact every two weeks. DESTRESS Nurses introduce the approach, monitor, answer questions, and insure primary care provider collaboration. The control intervention is optimized usual primary care. Blinded raters assess PTSD symptoms, depression, anxiety, somatic symptoms, physical health status, and occupational functioning at four timepoints. All study participants receive RN care management and are under the care of a primary care provider trained in evidence-based PTSD treatment who receives status reports from the DESTRESS nurse to include baseline psychiatric status.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred by a primary care providers in a participating primary care clinic.
- •Deployed to either Operation Iraqi Freedom or Enduring Freedom.
- •War-related trauma while deployed (may include military sexual trauma).
- •Current PTSD as addressed by the CAPS interview.
- •Reports routine access to computer, internet, and email.
- •Successfully uses Internet to coordinate baseline assessment appointment.
- •Provides research informed consent using local IRB-approved form.
- •Plans continued care at the enrolling primary care clinic for at least 4 months.
排除标准
- •Actively engaged in specialty mental health care in the previous two months.
- •Failed specialty mental health treatment for PTSD or associated condition.
- •Acute psychosis, psychotic episode, or psychotic disorder diagnosis within the past two years.
- •Active substance dependence disorder in the past year.
- •Active suicidal or violent ideation within the past two months.
- •Currently on an antipsychotic or mood-stabilizing agent.
- •Unstable administration schedule or dosing of any antidepressant, anxiolytic, or sedative-hypnotic (i.e., will exclude for any related medication changes in the two-months prior to randomization).
- •Acute or unstable physical illness.
结局指标
主要结局
PTSD Checklist (PCL)
时间窗: Baseline and 6 weeks, 12 weeks, and 18 weeks post randomization
Symptoms of PTSD were assessed using the PTSD Checklist-Military Version (PCL). The PCL is a self-report measure developed for measuring PTSD symptom severity and for estimating PTSD caseness when administration of a structured clinical interview is not feasible. Respondents rate PCL items on a 5-point scale ('not at all' through "extremely') to indicate the degree to which they have been bothered by each of 17 PTSD symptoms during the past month. Possible PCL scores range from 17 to 85.
次要结局
- PRIME-MD PHQ(baseline and 6 weeks,12 weeks, and 18 weeks post randomization)
- Medical Outcomes Study Short Form-36 (SF-36)(baseline, 6 wks, 12 wks, and 18wks)
- Attitude Regarding Mental Health Treatments(baseline, 6 weeks, 12 weeks, and 18 weeks)
- World Health Organization Health and Performance Questionnaire (HPQ).(baseline, 6 weeks, 12 weeks, and 18 weeks)
研究者
Charles Engel
Dir., Deployment Health Clinical Center, WRNMMC; Associate Professor, psychiatry, USUHS
Uniformed Services University of the Health Sciences