Treatment of Sleep Disturbances in Trauma-affected Refugees: A Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- Sleep on The Pittsburgh Sleep Quality Index
研究概览
简要总结
The overall aim of this study is to examine the effects of sleep enhancing treatment in refugees with PTSD.
详细描述
BACKGROUND:
Sleep disturbances are often referred to as a hallmark of PTSD. In a sample of 734 trauma-affected refugees undergoing psychiatric treatment at Competence Centre for Transcultural Psychiatry (CTP) in the period 2008-2012 99% reported sleep disturbances and nightmares.
In trauma-affected populations untreated sleep disturbances can uphold and exacerbate both sleep-related and non-sleep-related PTSD symptoms. Sleep disturbances may also affect the efficacy of first-line PTSD treatment and constitute a risk factor for poor outcome of psychiatric treatment. It has been argued that effective treatment of sleep disturbances may accelerate recovery in PTSD. There is a lack of randomised clinical trials on this relation in trauma-affected refugees.
The aim of this study is to examine sleep enhancing treatment in refugees with PTSD.
MATERIALS AND METHOD:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Adults (18 years or older)
- •Refugees or persons who have been family reunified with a refugee
- •PTSD pursuant to the International Classification of Diseases ICD-10 research criteria
- •Psychological trauma experienced outside Denmark in the anamnesis. Trauma is imprisonment or detention with torture (according to the United Nation definition of torture) or acts of cruel, inhuman and degrading treatment or punishment. Trauma can also be organised violence, long-term political persecution and harassment, or war and civil war experiences.
- •Sleep disturbances/ PSQI >8
- •Nightmares/ HTQ score on nightmare item ≥ "a little"
- •Signed informed consent
排除标准
- •Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F31.9). Patients are excluded only if the psychotic-like experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and/or depression
- •Current abuse of drugs or alcohol (F1x.24-F1x.26)
- •Known neurodegenerative disorder (Alzheimer's disease (AD), Parkinson's disease (PD), Levy-Body dementia (LBD))
- •In need of admission to psychiatric hospital
- •Pregnant and breastfeeding women and women of the reproductive age who wish to conceive during the project period.
- •Allergy towards active ingredients or excipients in mianserin
- •Lack of informed consent
研究组 & 干预措施
Mianserin
10-30 mg of mianserin af sleep enhancing
干预措施: Mianserin (Drug)
Imagery Rehearsal Therapy
Therapy focusing on nightmares
干预措施: Imagery Rehearsal Therapy (Behavioral)
mianserin and Imagery Rehearsal Therapy
Both mianserin and IRT
干预措施: Mianserin (Drug)
mianserin and Imagery Rehearsal Therapy
Both mianserin and IRT
干预措施: Imagery Rehearsal Therapy (Behavioral)
结局指标
主要结局
Sleep on The Pittsburgh Sleep Quality Index
时间窗: Change from baseline after approximately 6-8 months treatment
次要结局
- Symptoms of PTSD on The Harvard Trauma Questionnaire(Change from baseline after approximately 6-8 months treatment)
- Level of functioning on WHODAS 2.0(Change from baseline after approximately 6-8 months treatment)
- Symptoms of depression and anxiety on the Hopkins Symptom Check List(Change from baseline after approximately 6-8 months treatment)
- Life quality on the WHO-5(Change from baseline after approximately 6-8 months treatment)
- level of functioning on the Sheehan Disability Scale(Change from baseline after approximately 6-8 months treatment)
- Symptoms of depression and anxiety on Hamilton depression and anxiety scales(Change from baseline after approximately 6-8 months treatment)
- Sleep on Actigraph(two weeks recording at baseline and two weeks recording after approximately 6-8 months treatment)
- Sleep on the REM Sleep Behavior Disorder Screening Questionnaire(2 years)
- Nightmares on the Disturbing Dreams and Nightmare Severity Index(Change from baseline after approximately 6-8 months treatment)
- Level of functioning on the Global Assessment of functioning - Symptoms(Change from baseline after approximately 6-8 months treatment)
- pain on the Brief Pain Inventory short form(Change from baseline after approximately 6-8 months treatment)