Mindfulness-based Stress Reduction for Treatment of PTSD in Road Traffic Accident Victims: Evaluating Its Efficacy in a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Posttraumatic Stress Disorder Checklist for DSM-5
研究概览
简要总结
The goals of the study are to investigate the effects of mindfulness-based stress reduction (MBSR) on PTSD among road traffic accident victims. The main questions are: does MBSR exerts any effects on PTSD symptoms, quality of life and mindfulness?
Researchers will compare effects of MBSR with TAU on PTSD symptoms, quality of life and mindfulness.
Participants will be:
- administered few questionnaires at three time points
- administered MBSR once a week session for 6 weeks
详细描述
Problem Statement and Gap of Knowledge:
Posttraumatic stress disorder (PTSD) is a serious mental health condition that can develop both immediately after and long after exposure to an extraordinary traumatic event. According to relevant literature, the prevalence of PTSD among road traffic victims is very high. Some scholars have pointed out that the incidence of PTSD symptoms among traffic accident victims may be as high as 25%(Miller, Millar, & Davis, 2012). Some clinical studies have even shown that the incidence of PTSD in this group is 7.53%(Ye et al, 2009).Almost all PTSD patients experience great suffering, which often leads to significant impairment of daily bodily functions, social relationships and overall quality of life, thus triggering long-term and persistent psychological, physical and social consequences. Drug therapy and cognitive behavioural therapy (CBT) are currently the most commonly used traditional treatments in clinical practice to relieve PTSD symptoms. However, these treatments have revealed more limitations in clinical practice, such as drug side effects and limited treatment effects on patients(Stewart & Stotts, 2009). In addition, cognitive behavioural therapy (CBT) is confrontational in its treatment approach, which requires patients to confront traumatic memories. This can be extremely challenging for those patients who have difficulty regulating their emotions or who experience post-traumatic dissociation(Foa, Hembree & Rothbaum, 2005).
Because we have encountered all these problems in clinical treatment, we urgently need to explore more advantageous treatment methods that we hope will more effectively relieve symptoms of post-traumatic stress disorder (PTSD), reduce the impact of comorbid symptoms, and improve psychological resilience and quality of life in the long term. This has become the core issue in the current research field of PTSD. There is sufficient evidence to show that mindfulness-based stress reduction (MBSR) can effectively treat a variety of mental health problems, including PTSD, and has achieved good treatment results(Kabat-Zinn,1990). Although some studies have explored the effectiveness of mindfulness-based stress reduction (MBSR) in the treatment of post-traumatic stress disorder (PTSD), there is currently a lack of research focusing on the long-term efficacy and mechanism of MBSR in the group of road traffic accident victims. Especially in modern society, where the number of vehicles is increasing rapidly, the number of PTSD cases caused by traffic accidents is also on the rise. Therefore, it is particularly important to explore ways to adapt MBSR treatment methods to the needs of this special group.
Rationale/ Justification of study:
This study aims to measure the efficacy of mindfulness-based stress reduction (MBSR) on post-traumatic stress disorder (PTSD) in road traffic accident victims, to provide a more effective practical method for alleviating the condition of patients with post-traumatic stress disorder (PTSD). This study will demonstrate and provide a theoretical basis for the effectiveness of mindfulness-based therapy for PTSD patients, particularly road accident victims to enhance the degree of mindfulness when facing traumatic events through MBSR. However, research on PTSD and mindfulness therapy is still lacking. Therefore, it is very meaningful to explore the impact of mindfulness-based stress reduction (MBSR) on the efficacy of PTSD patients, particularly in road traffic accident victims where data is scarce.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
statisticians that analysed the data
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(a) Possession of a road traffic identification certificate issued by the public security traffic police department; (b) Age 18-60 years; (c) junior high school education or above and full civil capacity; (d) those who meet the diagnostic criteria for PTSD according to DSM-5-TR (Diagnostic and Statistical Manual for Mental Disorder 5th Edition-Text Revised) which occurred after road traffic accident; (e) A score of 31 or above on the PTSD Checklist for DSM-5 (PCL-5) indicating possibility of PTSD in diagnosis; and (f) those taking a stable dose of a single antidepressant for the past 2 weeks and willing to maintain on the dose until the end of the study.
排除标准
- •(a) Organic brain damage caused by road traffic accident; (b) A previous diagnosis of any mental illness; (c) Pregnant women; (d) Alcohol and drug dependence and abuse; (e) Inability to understand Chinese; (f) history of severe and unstable medical illnesses that are not suitable for participation in the study; (g) having participated in any psychotherapy before participating in the study, and (h) those with suicidal tendency.
研究组 & 干预措施
Control Group
In the TAU control group, it will be carried out as group therapy in a 2.5 hours (with 45 minutes home assignment) once a week session for 8 weeks. Home assignments will be provided at the end of each session. Non-specific and non-therapeutic components will be explained to participants. The acceptable number of sessions attended is at least six sessions, whereby those who attended less than that is considered to have insufficient intervention sessions.
Mindfulness-based stress reduction group
The intervention in the MBSR group will be carried out as group therapy in a 2.5 hours (with 45 minutes home assignment) once a week session for 8 weeks. Home assignments will be provided at the end of each session. The acceptable number of sessions attended is at least six sessions, whereby those who attended less than that is considered to have insufficient intervention sessions.
干预措施: mindfulness-based stress reduction (Behavioral)
结局指标
主要结局
Posttraumatic Stress Disorder Checklist for DSM-5
时间窗: Change in mean total score from baseline to post-intervention (8 weeks after intervention commence or immediately after completion of intervention) and from post-intervention to follow-up (12 weeks after completion of intervention)
The PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5) is currently one of the most commonly used self-assessment scales for evaluating symptoms of post-traumatic stress disorder (PTSD). It corresponds to the diagnostic criteria in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and is suitable for clinical assessment and research purposes. The scale is scored using a five-point scale ranging from 'not at all' to 'extremely severe', with a score range of 0 to 4(Weathers et al,2013). PCL-5 can not only be used to assess current PTSD symptoms, but also as a pre- and post-treatment monitoring tool to track changes in symptoms. The Chinese version of the PCL-5 scale was validated in a Chinese PTSD patient population, and showed excellent internal consistency with a Cronbach's α coefficient of 0.90 (Zhao et al,2017).
次要结局
- World Health Organization Quality of Life-Brief (WHOQoL-BREF)(Change of total score from baseline to post-intervention (8 weeks after intervention commence or immediately after completion of intervention) and from post-intervention to follow-up (12 weeks after completion of intervention))
- Five Facet Mindfulness Questionnaire (FFMQ)(Change of total score from baseline to post-intervention (8 weeks after intervention commence or immediately after completion of intervention) and from post-intervention to follow-up (12 weeks after completion of intervention))
研究者
Mohammad Farris Iman Leong Bin Abdullah
Principal investigator
Universiti Sultan Zainal Abidin
