跳至主要内容
临床试验/NCT04027452
NCT04027452已完成不适用

Electroconvulsive Therapy for Traumatic Memories: A Randomized Controlled Clinical Trial

Centre for Addiction and Mental Health2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2016年1月7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
28
试验地点
2
主要终点
Change in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) score

研究概览

简要总结

This study will investigate whether ECT treatment can reduce the effect of traumatic memories if those memories are recalled immediately prior to the ECT sessions. Participants will be randomized to either a recall of a traumatic memory or a neutral non-traumatic memory prior to their ECT sessions.

详细描述

Traumatic events contribute to the genesis of disorders such as post-traumatic stress disorder (PTSD) and depression, and memories of the event can cause ongoing distress. Short-term episodic memories are encoded by the hippocampus and gradually become consolidated through reciprocal connections with the cortex, resulting in long-term memories being stored in a distributed network throughout the cerebral cortex. There are no effective treatments currently for specifically targeting traumatic memories and reducing the distress they cause.

ECT is the most effective treatment for improving mood in patients with depression and there is new evidence emerging that suggests ECT can also improve PTSD symptoms independently of co-morbid depression. In addition, the main side-effect of ECT is memory loss, specifically for autobiographical details surrounding the course of ECT, but not typically affecting long-term episodic memory, nor procedural memories. Memories stored in the hippocampus are vulnerable to disruption by ECT because they rely on synaptic changes that are mediated by relatively unstable modifications in AMPA receptor and metabotropic glutamate receptor density. The investigators propose to exploit this feature of ECT, which normally is considered an undesirable side-effect of treatment, in an attempt to selectively reduce traumatic memories and the distress associated with them.

The investigators propose to recruit patients referred for ECT for treatment-resistant depression, who also have traumatic memories that are causing distress. These patients will be asked to write two narratives, one of the traumatic memory, and the other of a trivial, non-traumatic remote event. Patients will then be asked to listen to an audio recording of either the traumatic memory or the neutral memory (control group) immediately before their ECT sessions. The severity of the traumatic memory related symptoms will be assessed before and after the course of ECT using the Modified PTSD Symptom Scale (MPSS-SR) and the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). Data will be analyzed by comparing the change in overall MPSS-SR scores and CAPS-5 scores pre- and post-ECT between the experimental and control groups. Physiological data will also be collected at each ECT session during the time the participant is listening to the audio recordings. Heart rate and skin conductance will be measured prior to and during listening of the traumatic or non-traumatic memory, in order to determine if there is a change associated with a stress response, and whether this response normalizes in association with reduction of PTSD symptoms with treatment.

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 (Care Provider, Investigator, Outcomes Assessor)

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

  • Patient referred and accepted for ECT treatment at CAMH
  • Presence of traumatic memories
  • Able to write about their traumatic experience(s)
  • Capable of informed consent to participate in this study
  • Age 18 or greater
  • MPSS-SR re-experiencing score (items 1-4, 17) ≥ 20

排除标准

  • History of neurological or developmental disorder, including seizures
  • ECT treatment already started

结局指标

主要结局

Change in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) score

时间窗: Baseline, after ECT treatment course (an average of 4 weeks), and at 3 month follow up

30-item semi structured interview that is used to index of PTSD severity and assess PTSD symptoms over the past week. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, and impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, and features for the dissociative subtype (depersonalization and derealization). Administration requires identification of an index traumatic event to serve as the basis for symptom inquiry. Symptom severity scores range from 0 to 80, higher score indicates greater PTSD symptom severity.

Change in Modified PTSD Symptom Scale (MPSS-SR) score

时间窗: Baseline, after ECT treatment course (an average of 4 weeks), and at 3 month follow up

17-item self-report measure that assesses the DSM-III-R symptoms of PTSD. Score range from 0-119, higher score indicates greater PTSD symptom severity.

次要结局

  • Change in heart rate(Change of heart rate from 0-30 seconds of the audio recording to heart rate from 90-120 seconds of the audio recording.)
  • Change in The Quick Inventory of Depressive Symptomatology (Self-Report)(Baseline, after ECT treatment course (an average of 4 weeks), and at 3 month follow up)
  • Skin conductance(Change of skin conductance from 0-30 seconds of the audio recording to skin conductance from 90-120 seconds of the audio recording.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Albert Wong

Professor

Centre for Addiction and Mental Health

研究点 (2)

Loading locations...

相似试验