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临床试验/NCT05933109
NCT05933109已完成不适用

Augmentation of Imagery Rehearsal Therapy With Targeted Memory Reactivation for Post-Traumatic Stress Disorder (PTSD)

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Clinician-Administered PTSD Scale for DSM-5

研究概览

简要总结

With this protocol, investigators examine whether targeted memory reactivation (TMR), a technique used to strengthen memories, can accelerate remission of traumatic nightmares and post-traumatic stress disorder (PTSD) symptomatology. This protocol uses TMR during REM sleep to strengthen positive memories generated by Imagery Rehearsal Therapy (IRT), a recommended treatment of nightmares. Patients with PTSD are asked to perform 3 weekly IRT sessions and, while they generate a positive outcome of their recurrent nightmare, half of the patients are exposed to a sound S1 (TMR group), while the other half is not exposed to this sound (control group). All patients will perform IRT every evening at home and will be exposed to the sound S1 during REM sleep with a wireless headband, which automatically detects sleep stages. Clinical evaluation of the severity of PTSD and nightmares before and after (1-month follow-up and 3-months follow-up) this intervention takes place using the validated Clinically Administered PTSD Scale for DSM-5 (CAPS-5, primary outcome measure). The investigators hypothesize that patients treated with IRT and who are exposed, during REM sleep to a sound that had previously been associated with the new positive dream scenario of IRT (TMR group), will have more reduced frequency of PTSD severity and nightmares compared to participants with stimulation of the same, but non-associated, sound during REM sleep (control group).

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
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • with untreated persistent PTSD according to DSM-5 (> 1 month), suffering from chronic nightmares
  • with no active specific treatment for PTSD

排除标准

  • patients with active specific treatment for PTSD
  • patients with neurological disorders

研究组 & 干预措施

TMR group

Experimental

Patients will receive a sound S1 while they generate a positive outcome of imagery rehearsal therapy (IRT). They will also receive the sound S1 during REM sleep.

干预措施: Imagery Rehearsal Therapy and Targeted memory reactivation during REM sleep (Behavioral)

Control group

Active Comparator

Patients will not receive the sound S1 while they generate a positive outcome of imagery rehearsal therapy (IRT). During REM sleep, they will receive the same sound as the experimental group (S1) under the same conditions.

干预措施: Imagery Rehearsal Therapy (Behavioral)

结局指标

主要结局

Clinician-Administered PTSD Scale for DSM-5

时间窗: 3 months

Validated questionnaire that assesses PTSD symptoms, the score ranges from 0-80, zero indicating no symptom severity and 80 indicating the higher symptom severity.

Clinician-Administered PTSD Scale for DSM-5

时间窗: 1 month

Validated questionnaire that assesses PTSD symptoms, the score ranges from 0-80, zero indicating no symptom severity and 80 indicating the higher symptom severity.

次要结局

  • Beck Depression Inventory(3 months)
  • Pittsburgh Sleep Quality Index(3 months)
  • PTSD Checklist for DSM5(3 months)
  • Nightmare Frequency(3 months)
  • Nightmare Distress Questionnaire(3 months)
  • Positive emotions in dreams(3 months)
  • Positive emotions in dreams(1 month)
  • Nightmare Frequency(1 month)
  • Nightmare Distress Questionnaire(1 month)
  • PTSD Checklist for DSM5(1 month)
  • Beck Depression Inventory(1 month)
  • Pittsburgh Sleep Quality Index(1 month)

研究者

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

Lampros Perogamvros

Attending Physician

University Hospital, Geneva

研究点 (1)

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