Personalised relaxation practice to improve sleep and functioning in patients with CFS and depression: study protocol, 2018, Vollmer-Conna et al

Andy

Andy

Retired committee member
Andrew Lloyd is a co-author.
Abstract
Background
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.

Discussion
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.
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Open access at https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2763-8
 
Another study funded by the Mason Foundation. This one has people listening to white noise, Mozart or a guided relaxation every night in an effort to fix their fatigue. For goodness sake, there are so many better things to be spending money on. The Mason Foundation appears to have funded the whole study, even though it looks at major depression just as much as CFS.

The trial was registered in Dec 2016. Study recruitment commenced in April 2017 and was planned to continue until study size was reached. This study protocol was received by BMC in Feb 2018 and was accepted in June 2018. So, there are no results here, just the study protocol.

It appears that it is 'Open Peer Review', comments can be made at the bottom of the document.
 
On the plus side, if it doesn't work, it's more evidence that ME/CFS is not just 'tiredness' or 'fatigue' that can be fixed with soothing music. And they are at least doing some objective measures - whether they are relevant ones is another matter. Much too short a time scale for any real benefit or lack of it to be gauged.
 
Yes, the usual stuff.

I notice that they did a nice little dance around the issue of CBT and GET, claiming that response rates are only 30% (which is a huge overstatement, even if you only go by self report measures!), and that some people get worse.

I'm a little confused. This document is described as the trial protocol, but the trial was also preregistered some time ago: link here, and data collection commenced some months before this protocol was even submitted. So I would imagine the researchers would need to respect what they pre-registered, and not change anything substantive. I can't see any major differences between the two, but haven't looked that closely.
 
Trish said:
On the plus side, if it doesn't work
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Excuse my scepticism, but there's enough subjective measures there that they'll find something to justify calling this trial a success for some people. No more of that expensive GET that requires a therapist to run sessions and that just makes the patients bleat on about harms. No, give them headphones and either a white noise recording OR Mozart* and send them home. Evidence-based, personalised medicine at a fraction of the cost.

*And, for the pregnant patients, this option has the added benefit of making their babies smarter.
 
I share your skepticism, @Hutan. But if they replace GET with sleep music at least it might reduce the harm! But I agree with your central point that there are much better things to spend money and research effort on.

This reads to me like something dreamed up on the back of an envelope to create a research project for a student, not serious science, but dressed up as science by using some objective measures, even if not ones relevant to ME.
 
Good sleep is definitely a good thing for anyone with a chronic illness. Who doesn't feel worse when sleep deprived? I have no problem with that. But the idea that thinking the right thoughts will be all it takes to improve your sleep, now that's super questionable.
 
I find I'm much more likely to relax and fall asleep hearing about Harry Potter fighting Lord Voldemort, or Sherlock Holmes solving a case, than I am listening to a relaxation CD or whale music, or even Mozart. Soothing stuff bores me into wakefulness. I sometimes think I am very odd.
 
Trish said:
I find I'm much more likely to relax and fall asleep hearing about Harry Potter fighting Lord Voldemort, or Sherlock Holmes solving a case, than I am listening to a relaxation CD or whale music, or even Mozart. Soothing stuff bores me into wakefulness. I sometimes think I am very odd.
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I think many people are the same. That's why audiobooks are preferred to music for getting off to sleep. Perhaps it reminds us of our childhoods, if parents read to us? Or maybe it's precisely because it isn't repetitive enough to stick in the mind?
 
Trish said:
I find I'm much more likely to relax and fall asleep hearing about Harry Potter fighting Lord Voldemort, or Sherlock Holmes solving a case, than I am listening to a relaxation CD or whale music, or even Mozart. Soothing stuff bores me into wakefulness. I sometimes think I am very odd.
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I think I can out-odd you there. I do chess puzzles on my smartphone every night until my eyelids droop.
 
I had to switch from having Radio 4/World Service on low in the background all night to Classic FM as the talking was keeping me awake

but I only have the smooth classics programme going on catch up as it gets more up beat after that and that would keep me awake or wake me up

I have tried a lot of different stuff for sleep used to read myself to sleep until that stopped working and I would be reading until the early hours

Melatonin actually gets me to sleep most of the time.

Sleeping is a lot better than not sleeping but I agree with @Mij it doesnt address PEM

PEM is a major issue in sleep for me and my current low dose Melatonin doesnt combat PEM tired but wired, some kind of relaxation tape definitely doesnt work for tired but wired. for me experience so far is that the only thing to do is ride it out and a bit of distraction watching TV or coming on here for a bit. then get some sleep when it wears off - had tired but wired last night yuk
 
I've recently joined Spotify, and now my other half and I play soft rain all night. The main plus is that it absorbs noise, but in a more pleasant way than white noise. So I wake less in the night.

My sleep is bad, and I need drugs to get enough, but I can get away with less drugs if I don't wake too often in the night.

My other half has also taken the soft rain with him when travelling, and finds its a nice cue to sleep when he's in strange places. So it works as a good conditioned stimulus for sleep.

There's also streams, or the sounds of the ocean, or soft music, if you prefer that.
 
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There are also lots and lots of nature sounds videos on YouTube, that are several hours long. Rain, forests, streams, seashore, dawn chorus, frogs in swamps, etc.

Compared to audio only sites like Spotify, YT does have the disadvantage of having a video component, which adds to the amount of download data for those with data restrictions. But that component is often just a still image, so it isn't too bad.
 
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