Rapid Resolution Therapy (RRT) for Post-traumatic Stress Disorder (PTSD) Symptoms in Survivors of Sexual Violence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in The State Trait Anxiety Inventory (STAI: Spielberger et al, 1970)
研究概览
简要总结
Study to provide evidence of efficacy for Rapid Resolution Therapy in symptoms of PTSD, Anxiety, and Depression in survivors of sexual violence.
详细描述
The investigators will recruit 24 participants to complete pre-test measures, participate in a 3 hour therapy session of Rapid Resolution Therapy (RRT), and then re-test one week post treatment and 6 months follow up.
If participants do not report a "good result" following the 3 hour session, the investigators will offer a 1.5 hour follow up session Participants will receive free therapy for their participation, but will not be paid.
Participants will be men and women over the age of 18 who do not have a diagnosis of psychosis and are not actively suicidal and have experienced a single rape at least 3 months before enrolling in the study.
Sessions will be audio recorded and transcribed for construct validity (of RRT). Identifying in formation will be removed by the study coordinator before transcripts are coded for validity.
This study proposes to use the same methods as Rothbaum et al (2005) published in Journal of Traumatic Stress that compares Prolonged Exposure to Eye Movement and Desensitization and Reprocessing (EMDR) for PTSD Rape Victims. The investigators will compare our results to theirs. Both of their treatments were 8 sessions, and this study's treatment is one. They also include data for a control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-70 years old
- •self report experiencing a rape any time before 3 months prior to treatment
- •on PCL-C (Positive for PTSD)
- •score 3-5 on at least one item 1-5
- •score 3-5 on at least 3 items 6-12
- •score 3-5 on at least 2 items 13-17
排除标准
- •history of schizophrenia or psychosis current
- •suicidal risk
- •in an ongoing threatening situation (i.e. domestic violence)
- •participants who are pregnant or become pregnant during the study (if someone becomes pregnant during the study, we will complete treatment if she desires, but will not include data)
结局指标
主要结局
Change in The State Trait Anxiety Inventory (STAI: Spielberger et al, 1970)
时间窗: Pre-intervention, one week follow up, 6 month follow up
STAI is a 40-item self-report measure with two scales designed to assess state anxiety and trait anxiety. Items are score on a 4-point Likert scale, with 4 being most severe. 20 items measure state anxiety and 20 measure state anxiety. Scores on each scale range from 20-80, with lower scores indicating more mild anxiety and higher scores indicating clinical anxiety. We are looking for scores to go down with treatment and remain lower than baseline at 6 month follow up.
Change in PTSD Symptom Scale Self-Report- Civilian Version (PSS-SR: Foa et al, 1993)
时间窗: screening, one week post-treatment, 6 month follow up
A 17 item self-report measure that corresponds to the 17 DSM-IV PTSD symptoms. Items are rated 0 (not present) to 3 (very much). Responses create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score that ranges from 0 to 51. Score above 13 indicate a presence of PTSD. we expect to see scores decrease post-treatment and to stay lower than baseline at 6 month follow up.
Change in The Clinician-Administered PTSD Scale (CAPS-5: Weathers et al, 2015)
时间窗: pre-intervention (one month version), one week post intervention (past week version) , 6 months post intervention (one month version)
The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD and assess PTSD symptoms over the past week In addition to assessing the 20 Diagnostic and Statistics Manual- 5th Edition (DSM-5) PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). The scale measures 1) severity of PTSD symptoms 2) severity of PTSD clusters and 3) PTSD Diagnostic status.
Change in Beck Depression Inventory (BDI): beck et al, 1988)
时间窗: pre-intervention, one week post intervention, 6 month follow up
The BDI is a 21 item self-report questionnaire widely used in research on depression to evaluate cognitive and vegetative symptoms of depression. The inventory includes 21 items rated from 0 to 3, with 0 being absence of symptoms and 3 being extreme symptoms. A score between 1 and 16 indicates a low level of mood disturbance, 17-30 indicates Moderate depression, and 31 and up indicates severe or extreme depression. We are looking for a decrease in scores with treatment, and lower than baseline score at 6 month follow up.
次要结局
- Outcome Rating Scale (ORS: Miller and Duncan, 2000)(One week post intervention)
- Session Rating Scale (Miller et al 2002)(one week post intervention)