Macnamara Claire L, Cvejic Erin, Parker Gordon B, Lloyd Andrew R, Lee Gina, Beilharz Jessica E, Vollmer-Conna Ute
Department of Human Behaviour (Psychiatry), UNSW, Level 1, 30 Botany Street, Sydney, NSW, 2052, Australia.
School of Public Health, University of Sydney, Sydney, Australia.
Trials. 2018 Jul 11;19(1):371. doi: 10.1186/s13063-018-2763-8.
Chronic fatigue syndrome (CFS) and major depressive disorder (MDD) are both debilitating but heterogeneous conditions sharing core features of fatigue, unrefreshing sleep, and impaired functioning. The aetiology of these conditions is not fully understood, and 'best-practice' treatments are only moderately effective in relieving symptoms. Unrecognised individual differences in the response to such treatments are likely to underlie poor treatment outcomes.
METHODS/DESIGN: We are undertaking a two-group, parallel, randomised controlled trial (RCT) comparing the effects of a personalised relaxation intervention on sleep quality, daytime symptoms, and functioning in patients with CFS (n = 64) and MDD (n = 64). Following identification of the method that best enhances autonomic responding (such as heart rate variability), participants randomised to the active intervention will practise their recommended method nightly for 4 weeks. All participants will keep a sleep diary and monitor symptoms during the trial period, and they will complete two face-to-face assessments, one at baseline and one at 4 weeks, and a further online assessment to evaluate lasting effects of the intervention at 2 months. Assessments include self-report measures of sleep, wellbeing, and function and monitoring of autonomic responses at rest, in response to the relaxation method and during nocturnal sleep. Treatment outcomes will be analysed using linear mixed modelling.
This is the first RCT examining the effects of a personalised relaxation intervention, pre-tested to maximise the autonomic relaxation response, in patients with unrefreshing sleep and fatigue attributed to CFS or MDD. Detailed monitoring of sleep quality and symptoms will enable sensitive detection of improvements in the core symptoms of these debilitating conditions. In addition, repeated monitoring of autonomic functioning can elucidate mechanisms underlying potential benefits. The findings have translational potential, informing novel, personalised symptom management techniques for these conditions, with the potential for better clinical outcomes.
Australian and New Zealand Clinical Trials Registry (ANZCTR), ACTRN12616001671459 . Registered on 5 December 2016.
慢性疲劳综合征（CFS）和重度抑郁症（MDD）均为使人衰弱但异质性的病症，具有疲劳、睡眠不解乏和功能受损等核心特征。这些病症的病因尚未完全明确，“最佳实践”治疗方法在缓解症状方面仅具有中等效果。对这类治疗反应中未被认识到的个体差异可能是治疗效果不佳的原因。
方法/设计：我们正在进行一项两组平行随机对照试验（RCT），比较个性化放松干预对慢性疲劳综合征患者（n = 64）和重度抑郁症患者（n = 64）的睡眠质量、日间症状和功能的影响。在确定能最佳增强自主反应（如心率变异性）的方法后，随机分配至积极干预组的参与者将每晚练习推荐方法，为期4周。所有参与者在试验期间都要记录睡眠日记并监测症状，他们将完成两次面对面评估，一次在基线时，一次在4周时，以及一次进一步的在线评估，以评估干预在2个月时的持久效果。评估包括睡眠、幸福感和功能的自我报告测量，以及在休息时、对放松方法的反应期间和夜间睡眠期间对自主反应的监测。治疗结果将使用线性混合模型进行分析。
这是第一项RCT研究，考察了针对因慢性疲劳综合征或重度抑郁症导致睡眠不解乏和疲劳的患者，预先测试以最大化自主放松反应的个性化放松干预的效果。对睡眠质量和症状的详细监测将能够灵敏地检测出这些使人衰弱的病症核心症状的改善情况。此外，对自主功能的重复监测可以阐明潜在益处的机制。这些发现具有转化潜力，可为这些病症提供新的个性化症状管理技术，有可能带来更好的临床结果。
澳大利亚和新西兰临床试验注册中心（ANZCTR），ACTRN12616001671459。于2016年12月5日注册。
