Evaluation of a Rumination Intervention for Individuals With PTSD: A Case Series
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Weekly change of rumination: Response to Intrusion Questionnaire (RIQ; Clohessy & Ehlers, 1999; Murray et al., 2002; Steil & Ehlers, 2000)
研究概览
简要总结
After a traumatic event, it is common for thoughts to run through our minds over and over again. Typically, these include unanswerable questions like "why did this happen to me?", "what if I had done something differently?" Dwelling or ruminating on the past like this is often unhelpful and research has shown that it increases our chances of developing posttraumatic stress disorder (PTSD), a debilitating stress reaction. Once PTSD is in place, research shows that ruminating keeps the disorder going. It is unknown to what extent targeting rumination with an intervention to reduce its recurrence may help to alleviate PTSD symptoms. While rumination interventions using evidence-based cognitive behavioural therapy (CBT) have shown highly promising results in depression and anxiety research, no previous study has evaluated a stand-alone rumination intervention for individuals with PTSD.
The aim of this study is to examine the impact of a one-session online Rumination Intervention designed to reduce rumination in a small sample of 14 individuals who are currently awaiting treatment for PTSD in a British national mental health (NHS) service. The study will explore whether the Rumination Intervention reduces PTSD-related rumination, as well as PTSD and depression symptoms. It will also investigate how feasible and acceptable the intervention is for participants.
If the findings are promising, the intervention could be tested in a larger clinical study in the future. Results may help inform online interventions for PTSD.
详细描述
Please note: This study adopts a within and between-subjects concurrent multiple baseline A-B design will be used for this study. Due to the format of a case series, there will be no control group and no blinding. Participants will be compared to their own baseline (within) and between groups (delayed baseline for arm 2), meaning that individuals with a 3-week baseline will be compared to individuals with a 5-week baseline. This will be an experimental framework.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give informed consent for participation in the trial.
- •Willing and able to complete an online measures, online training and a phone or video call (this includes access to internet and to a computer, laptop, tablet or phone).
- •Aged 18-65 years.
- •English speakers and ability to read and write in English.
- •Availability to participate in 6-8 weeks of this study.
- •Suspected primary diagnosis of PTSD
- •Currently on the waitlist for Step 3 individual PTSD treatment in an Improving Access to Psychological Therapies (IAPT) service at the Oxford Health NHS Trust or Berkshire Healthcare Foundation Trust
- •Individuals must still have 9+ weeks left on the waitlist so start of PTSD treatment will not interfere with the study.
- •Score above cut-off for PTSD symptoms at screening (by scoring 33 or above on the PCL-5 scores)
- •Showing high rumination (by scoring "often" or "always" on any item of the RIQ)
排除标准
- •If it appears that a different disorder/mental health condition (not PTSD) is primary (e.g. depression, substance use).
- •Any other significant disease or disorder which, in the opinion of the investigators, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
研究组 & 干预措施
Rumination Invervention - 3 week baseline
Baseline measures will be collected weekly for 3 weeks.
All participants will then receive a one-session online Rumination Intervention for PTSD with a follow-up call to clarify/solidify learning.
干预措施: Rumination Intervention for individuals with PTSD (Other)
Rumination Invervention - 5 week baseline
Baseline measures will be collected weekly for 5 weeks.
All participants will then receive a one-session online Rumination Intervention for PTSD with a follow-up call to clarify/solidify learning.
干预措施: Rumination Intervention for individuals with PTSD (Other)
结局指标
主要结局
Weekly change of rumination: Response to Intrusion Questionnaire (RIQ; Clohessy & Ehlers, 1999; Murray et al., 2002; Steil & Ehlers, 2000)
时间窗: At screening, baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention
The RIQ is a 19-item self-report measure which examines responses to intrusive memories. It is divided into three subscales: suppression (6 items), rumination (6-8 items) and dissociation (5 items) which are scored on a scale from 0=never to 3=always. The scales have demonstrated adequate reliability and predictive validity in a range of studies (Beierl et al., 2019; Ehring, Ehlers, et al., 2008; Kleim et al., 2007). The internal consistency of the rumination subscale was between α=.80-.86. For the current study, only the 6-item rumination subscale will be used, in line with the measure recommended on the website of the Oxford Centre for Anxiety Disorder and Trauma (OxCADAT), who developed the measure. For the current study, the "high rumination" inclusion criteria was defined as individuals marking 2 (often) or 3 (always) on any of the 6 items.
次要结局
- Weekly change of repetitive negative thinking: Repetitive Thinking Questionnaire (RTQ-10; Mahoney et al., 2012; McEvoy et al., 2010)(Baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention)
- Weekly change of time spent ruminating(Baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention)
- Weekly change of PTSD: PTSD Scale for DSM-5 (PCL-5; Blevins et al., 2015)(At screening, baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention)
- Pre-post change of depression: Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)(Baseline week 1 and post-intervention week 2 (pre-post measure))
- Adherence measure(Week 2 post-intervention (end of study))
- Feasibility and acceptability measure(Week 2 post-intervention (end of study))