跳至主要内容
临床试验/NCT05996913
NCT05996913招募中不适用

An Intervention for Somatic Flashbacks in Post-Traumatic Stress Disorder: a Feasibility Study

University College, London2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
2
主要终点
What percentage of participants completed treatment?

研究概览

简要总结

This trial will explore the feasibility and acceptability of an intervention for Somatic flashbacks in Post-Traumatic Stress Disorder (PTSD). Imagery Rescripting (ImRs) will form a central part of the intervention.

The primary objective of this trial is to explore the acceptability and feasibility of delivering an intervention for the management of somatic flashbacks to a population of adults experiencing post-traumatic stress disorder.

The secondary objectives of this trial will be to examine if the intervention leads to any differences in participants experience of somatic flashbacks and their global symptoms of PTSD.

详细描述

Posttraumatic stress disorder (PTSD) is a reaction to a traumatic event where a person perceived a high risk of danger to themselves or others (e.g. sexual assault, car crash). Re-experiencing symptoms are a core component to diagnosis and can be understood as intrusive memories of a past traumatic event which are re-experienced involuntarily, as if they are happening in the present and contain more sensory details than nontraumatic memories. These 'intrusive memories' can be experienced as visual, auditory, olfactory, gustatory, and tactile. Other symptoms of PTSD include hyperarousal, emotional numbing and avoidance of stimuli which remind a person of the trauma. Trauma-focussed therapies have an established evidence-base and are widely used to treat PTSD. Their broad aim is to process the memories of a trauma and the meanings attached to it.

The current project seeks to explore the phenomenon of somatic re-experiencing, which we will refer to as somatic flashbacks. Within the field of trauma-focused therapy and research, the experience of somatic flashbacks is acknowledged anecdotally but lacks specific research. The limited research that does exist in this area is descriptive and focuses on somatic flashbacks of pain (see below). There is no existing empirical research exploring the management of somatic flashbacks more generally (e.g. re-experiencing of specific, bodily sensations that were present at the time of the trauma, including internal or external sensations, experience of warmth or coldness, and other physical sensations).

Four existing case reports describe participants who report experiencing somatic flashbacks (of pain) that resemble, in quality and location, the sensations experienced during the traumatic event. This includes: two participants who report waking during surgery; a veteran who re-experienced "pain like a shrapnel wound"; a veteran who re-experienced headaches after losing an eye; and a survivor of the 2005 London bombings who re-experienced pain flashbacks "similar in quality to the original electrocution pain" experienced during the explosion.

An additional study completed over a two-year period to assess the prevalence of pain flashbacks in a sample of participants with PTSD accessing an NHS trauma service reported that 49% of the sample reported experiencing somatic flashbacks of pain.

The current project aims to explore the feasibility of intervention featuring imagery rescripting (ImRs) and grounding in the management of somatic flashbacks amongst this population. ImRs was developed as a method to help activate a traumatic memory, bring corrective information into the memory, create a more favourable outcome to the memory and to support the participant to discover and express inhibited trauma-related emotional responses.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

What percentage of participants completed treatment?

时间窗: 1 year

The percentage of participants who agree to take part in the trial who go on to complete the intervention.

Treatment Acceptability/Adherence Scale score

时间窗: Through study completion, an average of 8 weeks

The Treatment Acceptability/Adherence Scale measures a participants experience of an intervention. The questionnaire is made of up 10 items and each item is measured on a scale from 1 (disagree strongly) to 7 (Agree strongly).

What percentage of participants using the service are eligible agreed to take part?

时间窗: 1 year

The percentage of participants who access the service who meet the eligibility criteria for the intervention

What percentage of participants who are eligible to take part, accept the intervention offer?

时间窗: 1 year

The percentage of participants who meet the eligibility criteria for the intervention and agree to take part in the trial.

次要结局

  • Changes in the intensity of somatic flashbacks(Through study completion, an average of 8 weeks)
  • Changes in the frequency of somatic flashbacks(Through study completion, an average of 8 weeks)
  • Changes in the distress associated with somatic flashbacks(Through study completion, an average of 8 weeks)
  • Changes in global symptoms of PTSD(Through study completion, an average of 8 weeks)
  • Changes in participants sense of ability to cope with the somatic flashbacks(Through study completion, an average of 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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