Randomized Trial of Telephonic Psychotherapy and Case Management for Combat-Related Posttraumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Posttraumatic Stress Disorder Checklist - Civilian Version (PCL)
研究概览
简要总结
This study will evaluate a telephone-delivered cognitive-behavioral psychotherapy intervention designed for primary care treatment of combat-exposed service members with PTSD. The investigators will assess Posttraumatic Stress Disorder (PTSD) symptoms, mental health-related and occupational functioning, and symptoms of depression, anxiety, and somatization.
详细描述
This is a randomized controlled trial that will compare DESTRESS-T to Optimized Usual Care (OUC). Optimized Usual Care is usual primary care PTSD treatment, plus a telephone care management program that includes: four outreach calls, feedback to the treating primary care provider (PCP), and care coordination.
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
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years
- •DSM-IV diagnosis of PTSD (derived from the CAPS) due to combat in OIF/OEF deployment
- •Active duty personnel
排除标准
- •Active suicidal or violent ideation within the past two months as assessed by the MINI and a supplementary form developed by the project team (see Appendices)
- •Current participation in any active psychotherapy (e.g., psychoanalysis, CBT) for mood, anxiety or substance use disorders (as determined via service member self report and/or check of medical record)
- •Recurrent PTSD treatment failure in psychotherapy, as determined via consensus of study team members (Dr. Charles Engel, Dr. Brett Litz, and Dr. Kristie Gore)
- •Current alcohol dependence, as assessed by MINI
- •Acute psychosis, psychotic episode, or psychotic disorder diagnosis within the past year, as assessed by the MINI
- •Currently on an antipsychotic or mood-stabilizing agent for bipolar disorder or any disorder with psychotic features, as determined by medical record and/or self report
- •Unstable administration schedule or dosing of any antidepressant, anxiolytic, or sedative-hypnotic (i.e., will exclude for any related medication changes in the month prior to randomization), as determined by medical record or service member self report
- •Acute or unstable physical illness based on the judgment of the patient's primary care clinician and the study team.
结局指标
主要结局
Posttraumatic Stress Disorder Checklist - Civilian Version (PCL)
时间窗: Baseline, 12 weeks, 18 weeks, and 24 weeks
Symptoms of PTSD will be assessed using the PTSD Checklist-Civilian Version. 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
- Medical Outcomes Survey Short-Form-12 (SF-12)(Baseline, 12 weeks, 18 weeks, and 24 weeks)
- World Health Organization Health & Work Performance Questionnaire (HPQ)(Baseline, 12 weeks, 18 weeks, and 24 weeks)
- Patient Health Questionnaire (PHQ)(Baseline, 12 weeks, 18 weeks, and 24 weeks)
- Generalized Anxiety Symptom Severity (GAD-7)(Baseline)
- Sheehan Disability Scale (SDS)(baseline, 12 week, 18 week and 24 week)
- Alcohol Use Disorders Identification Test-Civilian version (AUDIT-C)(baseline, 12 week, 18 week, and 24 week)
- Numeric Rating Scale for Pain (NRS).(baseline, 12 week, 18 week, and 24 week)
研究者
Charles Engel
Dir., Deployment Health Clinical Center; Associate Professor, psychiatry, USUHS
Uniformed Services University of the Health Sciences