RecruitingACTRN12616001671459

Personalised relaxation practice to improve sleep quality in patients with chronic fatigue syndrome and depression: A Randomised Control Trial

Personalised relaxation practice to improve sleep and functioning in patients with chronic fatigue syndrome and depression: A Randomised Control Trial


Sponsor

University of New South Wales

Enrollment

128 participants

Start Date

May 16, 2017

Study Type

Interventional

Conditions

Summary

Debilitating fatigue; unrefreshing sleep and poor daytime functioning are core features of many neuropsychiatric conditions including chronic fatigue syndrome (CFS) and major depression. Understanding of the aetiologies of these conditions is still incomplete and symptom management strategies have only limited efficacy. Accumulating evidence suggests that abnormalities in the function of the autonomic nervous system play a role in the sleep disturbance and chronic fatigue in these conditions. In particular, autonomic activity is characterized by neural hyper-vigilance and a marked loss of parasympathetic, vagus nerve activity that persist even during sleep. Measures of beat-to-beat heart rate variability (HRV) provide well-established, reliable indices of autonomic functioning, which consistently correlate with the severity and outcome of a spectrum of fatiguing disorders, including autoimmune and cardiovascular disease, chronic pain, depression, and CFS . For example, low HRV was repeatedly found to be a strong correlate of unrefreshing sleep, daytime fatigue and cognitive impairment in CFS. Mindfulness-based stress reduction and relaxation methods are increasingly utilised with the aim to restore autonomic balance. It is believed that the beneficial effects of these approaches are mediated via their impact on neural circuits involved in self-regulation, and on key stress-response pathways. However, individuals can have very different responses to different relaxations methods; and recent analyses revealed that some patients do not respond optimally to some. The main of the current study is to conduct a randomized control trial (RCT) to determine the efficacy and specific benefits of a 4 week personalised relaxation intervention, pre-tested to optimise the individuals' own HRV. Subjective health outcomes and parasympathetic autonomic activity (indexed by HRV) in patients with CFS and depression will be compared to a ‘monitoring only’ control condition. We anticipate that daily practice of a personalised relaxation method before sleep will be substantively more effective in improving sleep quality, daytime fatigue and functioning in both patient groups compared to treatment as usual with symptom monitoring. We further anticipate that restoration of HRV will contribute to positive health outcomes. The findings from this research will facilitate a better understanding of the pathophysiological mechanisms operating in chronic fatigue conditions.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a personalised relaxation practice — chosen based on which method best activates the individual's own heart rate variability (a measure of nervous system balance) — can improve sleep quality and reduce fatigue and daytime problems in people with chronic fatigue syndrome (CFS) or depression. Participants will practise a daily relaxation exercise before sleep for 4 weeks and be compared to a group that monitors symptoms only. You may be eligible if: - You are between 18 and 65 years old - You meet the diagnostic criteria for chronic fatigue syndrome or major depression (DSM-V) - You have normal or corrected hearing - You have sufficient English to follow the guided relaxation activities and fill in questionnaires You may NOT be eligible if: - You are pregnant - You have a primary sleep disorder (e.g., severe sleep apnoea), heart condition, uncontrolled diabetes, or psychotic disorder - You take regular medications that affect the autonomic nervous system, such as beta-blockers or blood pressure medications - You are currently engaged in another psycho-behavioural intervention Talk to your doctor about whether this trial might be right for you.

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Interventions

Participants randomly allocated to the intervention will be assigned to practise the relaxation method that optimizes de-arousal, determined from the results at the initial autonomic assessment. Labor

Participants randomly allocated to the intervention will be assigned to practise the relaxation method that optimizes de-arousal, determined from the results at the initial autonomic assessment. Laboratory-based autonomic measures include recordings of 3-channel electrocardiogram (ECG), respiration, sweat response and pulsatile skin blood volume. To obtain a baseline recording participants will rest in silence for 10 minutes. This is followed by the presentation of each of the three relaxation methods, order counter balanced across participants. The relaxation method which generates the greatest increase in heart rate variability (HRV), high frequency normalised units (HF nu) relative to resting baseline will be assigned to the participant for nightly practice. This trial will utilise three different relaxation methods: ‘Guided Relaxation’, ‘Gentle Noise’, and ‘Instrumental Music’, each consisting of pre-recorded 10 minute segments. The Guided Relaxation segments are a calming voice talking through body awareness and/or progressive relaxation.The Gentle noise segments are soft, undulating white noise which sound similar to the ocean or rain. The Instrumental Music segments are calming musical pieces such as Mozart's Flute and Harp Concerto in C, K.299 2nd Movement. Participants will have free online access to their assigned method and will be able to download the recordings to their smartphone or media device, or if preferred an MP3 player will be provided. Each participant will be provided with seven variations of their assigned method to maximise enjoyment and prevent negative effects of frequent repetition. Participants will be instructed to practice their assigned method at a minimum before bedtime every evening for 4 weeks, and may use at other times if they feel comfortable. Participants will also keep a brief log of their sleep, activity, symptoms, and time spent practising their assigned method during this period. Weekly phone contact will be made to enhance engagement and compliance,


Locations(1)

NSW, Australia

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