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临床试验/NCT05383846
NCT05383846已完成不适用

Exposing Narrative Exposure Therapy

University of Nottingham2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2022年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
Change in autobiographical memory integration during NET intervention. A coding manual has been created by the research team to assess the posited mechanism of change- Autobiographical Memory Integration Coding Tool

研究概览

简要总结

The main purpose of the study is to further develop an existing measure of autobiographical memory integration (ABMI) to investigate and clarify the ABMI change process specific to narrative exposure therapy (NET).

详细描述

Traumas are events which include witnessing or being at the risk of, death, violence, and sexual violation. Experiencing trauma can lead to psychological and physiological changes, and an individual's mental health can deteriorate to the point where a diagnosis of Post-traumatic stress disorder (PTSD) is given; 10-20% of people develop enduring symptoms, with effective treatment being a challenge.

While being exposed to trauma does not lead to PTSD, there is a dose-response relationship between the severity and duration of traumatic events and developing PTSD, suggesting that more complex forms of PTSD can develop if a person is subjected to multiple traumatic events. Complex post-traumatic stress disorder (CPTSD) occurs when a person is subjected to multiple prolonged traumas of an interpersonal nature, where escape is impossible. Different treatment approaches are needed for PTSD and CPTSD.

One therapy which has received support for treating CPTSD is Narrative Exposure Therapy (NET). NET is a National Institute for Health and Care Excellence recommended short-term manualised therapy. NET appears to be a well-tolerated treatment and has consistently low attrition rates when compared to other therapies. There is also emerging evidence of NET's effectiveness in the general population. The central aim of NET treatment is re-integration of contextual information and the traumatic memory into an autobiographical lifeline; this occurs through narrating the memory and involves prolonged exposure and habituation, and integration of the trauma memory into an autobiographical context. Despite NET's successes, its mechanisms of change have not been evidenced empirically, especially the element of contextualisation and integration of trauma into autobiographical memory (ABM). Four participants will be recruited with the support of local staff working in mental health services across Nottinghamshire. Participants will receive between twelve to fourteen weekly interventions sessions. Changes will be explored through process and outcome measures administered before, during, and after the intervention and interviews will be conducted at the end to gather participants experiences.

The study is supported by The University of Nottingham. Potential benefits include providing participants with an intervention to resolve their trauma and also to provide a theoretical contribution by either proving or refuting the process measures posted by NET.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Other
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

入选标准

  • Between the ages of 18-65
  • Are able to give fully informed consent
  • Experiencing traumatic stress resulting from multiple traumatic events (no formal diagnosis of PTSD/CPTSD is needed)
  • Are able to communicate verbally and are fluent in English
  • Have no on-going current trauma focused therapy
  • Appropriate and ready for NET
  • Referred to either Step 4 Psychological Services or Centre for Trauma

排除标准

  • Under the age of
  • Above the age of
  • Currently experiencing an episode of psychosis.
  • Have an intellectual disability.
  • Are actively suicidal.
  • Are non-fluent in English.
  • Are currently abusing substances.

结局指标

主要结局

Change in autobiographical memory integration during NET intervention. A coding manual has been created by the research team to assess the posited mechanism of change- Autobiographical Memory Integration Coding Tool

时间窗: Throughout intervention phase of the study, for approximately 24-28 weeks

A coding manual has been created by the research team to assess the posited mechanism of change. The primary outcome (process) measure is autobiographical memory integration (ABMI) as this is a posited mechanism of change in NET. An existing coding measure (Jager et al., 2014; Lane, 2019) has been adapted for the purpose of the study, to include more areas measuring phenomenological constructs of autobiographical memory. The coding measure that has been created by the researcher will cover areas such as: Total word count of narratives (Gray \& Lombardo, 2001); disorganisation (Harvey \& Bryant, 1999)- repetition of phrases, confusion, and disjointedness; fragmentation (Foa et al., 1995)- unfinished thoughts, repetition of words, speech filler; vividness; time and place details; emotional distancing and sensory details (Boyacioglu \& Akfirat, 2014). The measure will be used to code transcripts on a session-by-session basis and is therefore a process measure (primary aim of study).

次要结局

  • Changes in heart rate and heart rate variability during the NET intervention, as assessed by the Polar H10 chest strap(Throughout the intervention phase of the study, for approximately 24-28 weeks)
  • Change in depression, anxiety, and stress between the baseline, NET intervention, and up to 1 month follow-up phase- as assessed by the Depression Anxiety and Stress Scale 21 (DAAS-21; Lovibond & Lovibond, 1995)(Throughout the study, for approximately 32 weeks)
  • Process measure of habituation: Subjective Unit of Distress (SUD; Wolpe, 1969)(Throughout the intervention phase of the study, for approximately 24-28 weeks)
  • Change in symptoms of post-traumatic stress disorder between the baseline, NET intervention, and up to 1 month follow-up phase- as assessed by the Impact of Events Scale Revised (IES-R; Weiss & Marmar, 1997)(Throughout the study, for approximately 32 weeks ])
  • Change in body awareness and autonomic reactivity during NET session, as assessed by the Body Perception Questionnaire Short Form - Autonomic Nervous System (Porges, 1993, 2015)(Throughout the intervention phase of the study, for approximately 24-28 weeks ])

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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