Randomized Clinical Trial of Imagery Rescripting Treatment In Veterans With Trauma-Related Nightmares And Posttraumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR), Beck Depression Inventory-II (BDI-II)
研究概览
简要总结
Research shows that symptoms of posttraumatic stress disorder (PTSD) are particularly high in veterans, and that trauma-related nightmares and sleep disturbances are common in veterans with PTSD. This is of concern because people with these problems will often use unhealthy ways of coping. Although trauma-related nightmares and difficulty sleeping are highly distressing, there are helpful treatments that do not involve taking medication. One of these treatments teaches specific skills to help people improve their sleep habits and to change their nightmares so that they are less upsetting. This treatment can be very helpful and research shows that people experience decreases in the frequency and severity of their nightmares, decreased symptoms of depression and PTSD, and improved sleep quality and quantity after completing treatment. However, because this treatment has only been studied with civilians, it is not clear how well this treatment works for veterans.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be:
- •patients at the VA in the Trauma Recovery Program;
- •English-speaking;
- •reporting at least one Posttraumatic Nightmare in the past week (due to any type of trauma);
- •have an existing PTSD International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM); and
- •consenting to be randomized into treatment.
- •In addition, patients must agree to allow their assessment and therapy sessions to be video/audiotaped for the purposes of supervision and treatment integrity ratings. Participants receiving other forms of group or individual psychotherapy and/or psychotropic medication are eligible for the nightmare treatment condition of the study, provided that those interventions do not specifically target nightmares or PTSD. Thus, the study interventions will be in addition to standard care, except as indicated above.
排除标准
- •with current active suicidal/homicidal ideation and intent;
- •with current substance dependence;
- •a diagnosis of bipolar or psychosis; 4) prescribed the medication Prazosin (a psychotropic medication for the treatment of nightmares).
- •Patients in the nightmare treatment condition of the study will also be excluded if they are actively participating in another psychosocial treatment directly addressing their PTSD symptoms. Patients will not be excluded if they are taking psychotropic medication (except for Prazosin) and may continue to take their medication as prescribed throughout the study.
结局指标
主要结局
Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR), Beck Depression Inventory-II (BDI-II)
时间窗: Baseline, prior to each session, post-assessment, 3-month follow-up
次要结局
- Posttraumatic Cognitions Inventory (PTCI)(Baseline, post-assessment, 3-month follow-up)
- Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI),(Baseline, post-assessment, 3-month follow-up)
- Trauma Related Nightmare Survey (TRNS)(Baseline, post-assessment, 3-month follow-up)
- Clinician-Administered PTSD Scale (CAPS)(Baseline, post-assessment, 3-month follow-up)
- Modules of the Mini-International Neuropsychiatric Interview (MINI)(Baseline)
- Treatment Evaluation Inventory (TEI)(Post-assessment)
- Client Satisfaction Questionnaire (CSQ)(Post-assessment)