Abstract
BackgroundChronic 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/designWe 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.DiscussionThis 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.Trial registrationAustralian and New Zealand Clinical Trials Registry (ANZCTR), ACTRN12616001671459. Registered on 5 December 2016.
Highlights
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
This is the first randomised controlled trial (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
We found that engagement with four different methods elicited significant differences in vagal activity (HRV, continuously monitored)
Summary
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 sympathetic division is concerned with energy-demanding processes during times of activity and stress (e.g. the ‘fight-or-flight response’), whereas the parasympathetic division (notably via action of the vagus nerve) is associated with vegetative and restorative functions. These two divisions operate together to maintain homeostasis. Optimal autonomic function is characterised by flexible adaptation to environmental challenges and a marked increase in vagal activity during rest (reflected by high HRV), whereas low HRV and a shift towards sympathetic dominance reflect a vigilant, defensive physiological state lacking dynamic flexibility, suggestive of a system under stress [19]
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