Nonattachment Training for Post Traumatic Stress Recovery: a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Nonattachment Scale
研究概览
简要总结
This pilot study aims to investigate the effectiveness of a novel, co-created intervention based on principles of nonattachment for individuals recovering from Post-Traumatic Stress (PTS).
Objectives include:
- Determine whether participants undertaking nonattachment-based training have higher levels of nonattachment (as indicated by NAS Scale) after completing program.
- Determine whether nonattachment levels are impacted after 3 months
- Determine whether PTS symptoms are impacted by training/intervention
详细描述
This study will be a pilot randomised controlled trial with an embedded qualitative arm, which will be used to analyse and refine the novel intervention for a second RCT in the future. The study will be registered in a trial registry upon confirmation of ethics approval.
Recruitment will take place primarily through PTSD UK, the organisation that has generously permitted access to social media followers for the co-creation of the intervention itself (Appendix B). Recruitment points will also include Reddit, Facebook, Instagram, and threads/X sites operated by the researcher and their supervisor as well as other relevant groups (permission to post the advert will be sought from the sight admin as appropriate).
Participants will be screened for exclusionary criteria, and then, upon meeting appropriate inclusionary criteria, be prompted to undertake the following baseline assessments:
- Nonattachment Scale (NAS)- a 30-item Likert scale informed by Buddhist principles measuring aspects such as psychological flexibility, nonreactivity, and capacity for recovery after emotional disturbance.
- The Acceptance and Action Questionnaire - version II (AAQ-II) - a 7-item Likert scale measuring psychological inflexibility and experiential avoidance.
- FFMQ- a 39-item Likert scale derived from factor analysis of multiple existing assessments designed to measure mindfulness in daily life.
- Posttraumatic Stress Disorder Checklist (PCL-5) in which participants are prompted to rate on a 5-point Likert scale how much each of the 20 included problems or complaints.
- International Trauma Questionnaire (ITQ) - an 18-item Likert scale based on the World Health Organisation's ICD-11 principles for PTSD and CPTSD.
These assessments (except for NAS) were commonly utilised in the systematic review of nonattachment in clinical applications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current or recent (within 12 months) diagnosis of PTSD (self-disclosed) OR
- •Participants meeting diagnostic requirements of the ITQ OR
- •Participants meeting diagnostic requirements of the PCL-C
- •Participants willing and able to engage in self-directed course content (self-disclosed)
- •Participants willing and able to engage with contemplative principles and practices (self-disclosed)
排除标准
- •Non-English-speaking participants OR participants with a primary residence outside the UK
- •Under the age of 18
- •Participants with comorbidities such as drug or alcohol misuse which could prevent successful intervention engagement
- •Participants diagnosed with a psychotic disorder
结局指标
主要结局
Nonattachment Scale
时间窗: From enrollment to the end of treatment at 8 weeks, and again 3 months later.
This study seeks to understand the impact of the program on levels of nonattachment. Details of the Nonattachment scale (NAS)can be found here: DOI: 10.1080/00223890903425960 NAS is a 30-item Likert scale informed by Buddhist principles measuring aspects such as psychological flexibility, nonreactivity, and capacity for recovery after emotional disturbance. Minimum value is 30 (all answers =1). Maximum value is 180 (all answers = 6). Higher score values are associated with better outcomes.
次要结局
- Self-reported experiences of Post Traumatic Stress Symptoms using a combination of established trauma-based assessments, and qualitative analysis.(From enrollment to the end of treatment at 8 weeks, and again 3 months later.)
研究者
Lindsay Tremblay
Principal Investigator
University of Derby