ACTRN12619000642189终止未知
A Pilot Randomised Controlled Trial Investigating the Effects of Cognitive Behavioural Therapy for Insomnia (CBT-I) with and without Imagery Rehearsal Therapy (IRT) on Sleep Quality for Ex-Service Personnel with Insomnia and Nightmares in the Context of Posttraumatic Stress Disorder (PTSD) and Obstructive Sleep Apnoea (OSA)
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Male or female ex-serving Australian Defence Force personnel (i.e. veterans)
- •Age greater than or equal to 18 years
- •Diagnosis of PTSD: Have an accepted diagnosis of PTSD with the Australian Department of Veteran Affairs, or meet diagnostic criteria for lifetime PTSD according to the CAPS-5
- •Insomnia: A score of greater than or equal to 15 on the ISI (clinical insomnia, moderate severity)
- •Nightmares: Distressing nightmares, with a frequency of at least 2 per month
- •Poor sleep: A score of >5 on the PSQI
- •Stable pharmacological treatment for any condition for at least 1 month prior to baseline
- •Willingness and ability to attend CBT-I or CBT-I+IRT treatment sessions as required according to study protocol
排除标准
- •Current bipolar I disorder (presence of manic episode in the past 5 years): Meets DSM-5 diagnostic criteria (as measured by the MINI 7.0), where further screening is indicated by the DSM-5 Self-Rated Level 1 Cross Cutting Symptom Measure-Adult.
- •Schizophrenia: Meets DSM-5 current diagnostic criteria (as measured by the MINI 7.0), where further screening is indicated by the DSM-5 Self-Rated Level 1 Cross Cutting Symptom Measure-Adult.
- •Current psychosis: Meets DSM-5 diagnostic Criterion A and B of schizophrenia diagnosis (as measured by the MINI 7.0), where further screening is indicated by the DSM-5 Self-Rated Level 1 Cross Cutting Symptom Measure-Adult.
- •Current imminent risk of suicide, as indicated by the Columbia Suicide Severity Rating Scale
- •Unstable psychiatric condition, as indicated by hospitalisation for any psychiatric condition in the past four weeks
- •Any neurological disorder known to impact sleep (e.g., narcolepsy, Parkinson’s disease)
- •Previous diagnosis of moderate to severe traumatic brain injury (TBI) (i.e., loss of consciousness for more than 30 minutes) in the past five years
- •Females who are pregnant or breastfeeding
- •Inadequate circumstances for sleep e.g. night shift-worker
- •Currently receiving exposure-based, trauma-focused therapy (e.g. prolonged exposure therapy, trauma-focused cognitive behavioural therapy and eye movement desensitisation reprocessing (EMDR) for PTSD
- •Currently receiving cognitive behavioural therapy for insomnia (CBT-I)
- •Severe OSA requiring immediate treatment e.g. severe OSA (respiratory distress index (RDI) greater than or equal to 30 events/hour) with a score of greater than or equal to 15 on the ESS, and have been involved in a sleep or vigilance related car accident or near miss, or very severe OSA (RDI<50) with <70% saturation with cardiac arrhythmia
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