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临床试验/NCT00291031
NCT00291031已完成1 期

A Randomised Controlled Trial of Imagery Rehearsal Therapy (IRT) of Nightmares in a Psychiatric Population

GGZ Centraal6 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2006年2月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
112
试验地点
6
主要终点
Frequency of nightmares scored in prospective daily nightmare logs

研究概览

简要总结

The purpose of this study is to determine whether Imagery Rehearsal Therapy(IRT) is effective in the reduction of the number of nightmares and the nightmare distress in a population of patients with psychiatric disorders.

详细描述

Within the normal population 4-8% of the people suffer regularly from nightmares. Clinical observations show that nightmares are a common problem for patients who suffer from all kinds of psychiatric disorders, and not just for the patients diagnosed with PTSD. Often nightmares can lead to sleep disorders, which have a negative impact on emotional well-being and cognitive functioning during the day. As well as this a strong relationship between severity of nightmares and severity of psychopathology has been found. This gives a strong argument for treatment of nightmares as a symptom, separate from the psychiatric disorder.

A few controlled studies of the treatment of nightmares have been published, in which behavioral therapy, relaxation techniques, exposure and systematic desensitization have been studied, all of which have shown positive results. But these techniques do not seem to reduce the number of nightmares in patients who suffer from PTSD. These last few years more controlled studies of a cognitive behavioral technique called 'Imagery Rehearsal Therapy' (IRT) have been published. With IRT patients have to change the script of their nightmares into a different outcome, and rehearse this new script using cognitive imagery a few times a day.

Comparisons: treatment of nightmares with IRT compared to a waitlist control group who do not get IRT until 6 months later.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients referred to GGZ Centraal (previously Symfora groep) by their family doctor/GP for treatment of a psychiatric disorder. Patients that suffer from anxiety disorders, eating disorders, mood disorders and/or personality disorders.
  • Inclusion Criteria:
  • Minimum of 3 nightmares per month
  • Nightmares are associated with distress in daily life
  • Subject wants to get treatment for the nightmares

排除标准

  • Imagery rehearsal therapy for nightmares in the past
  • Psychotic disorders
  • Acute psychiatric crisis
  • Mentally challenged or neuropsychiatric syndrome
  • Severe addiction problems
  • Insufficient mastery of the Dutch language

结局指标

主要结局

Frequency of nightmares scored in prospective daily nightmare logs

时间窗: Daily logs for 18 weeks, then periods of 4 weeks every 3 months

Frequency of nightmares scored on the Nightmare Frequency Questionnaire

时间窗: At beginning of trial, 4, 16, 30, 42 and 56 weeks

次要结局

  • Intensity of nightmares scored in prospective daily nightmare logs(Daily logs for 18 weeks, then periods of 4 weeks every 3 months)
  • Effects of nightmares scored on the Nightmare Effects Survey(1, 4, 16, 30, 42 and 56 weeks)
  • Nightmare distress scored on the Nightmare Distress Questionnaire(1, 4, 16, 30, 42 and 56 weeks)
  • Sleep problems scored on the SLEEP-50(1, 4, 16, 30, 42 and 56 weeks)
  • Psychiatric symptoms scored on the Symptom Check List (SCL-90)(1, 4, 16, 30, 42 and 56 weeks)
  • Symptoms of post-traumatic stress disorder scored on the Zelf Inventarisatie Lijst PTSS ZIL (= PTSD Inventory)(1, 4, 16, 30, 42 and 56 weeks)
  • Quality of life scored on the abbreviated World Health Organization Quality of Life scale (WHOQoL-Bref)(1, 4, 16, 30, 42 and 56 weeks)
  • Nightmare efficacy and content measured by Nightmare Efficacy & Content Questionnaire(1, 4, 16, 30, 42 and 56 weeks)

研究者

发起方
GGZ Centraal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Annette van Schagen

Clinical psychologist

GGZ Centraal

研究点 (6)

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