Personalised relaxation practice to improve sleep and functioning in patients with chronic fatigue syndrome and depression: study protocol for a randomised controlled trial

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.

TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ANZCTR), ACTRN12616001671459 . Registered on 5 December 2016.

Source: Macnamara CL, Cvejic E, Parker GB, Lloyd AR, Lee G, Beilharz JE, Vollmer-Conna U. Personalised relaxation practice to improve sleep and functioning in patients with chronic fatigue syndrome and depression: study protocol for a randomised controlled trial. Trials. 2018 Jul 11;19(1):371. doi: 10.1186/s13063-018-2763-8.  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6042263/ (Full article)

Pilot study investigating the utility of a specialized online symptom management program for individuals with myalgic encephalomyelitis/chronic fatigue syndrome as compared to an online meditation program

Abstract:

BACKGROUND: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a long-term, debilitating condition that impacts numerous areas of individuals’ lives. The two predominant treatment options for ME/CFS are cognitive behavioral therapy and graded exercise therapy; however, many people have found these techniques unacceptable or even damaging. This pilot study aimed to evaluate the utility of a specialized online symptom management program for ME/CFS in comparison to an online meditation program in an effort to ascertain whether this tool could be a further option for those with ME/CFS.

METHODS: THIS EXPERIMENTAL DESIGN CONSISTED OF TWO INTERVENTIONS: a specialized online symptoms management program (N=19) and a control intervention based on an online meditation website (N=9). A battery of questionnaires, including measures of multidimensional fatigue, illness-specific symptoms, perceived control, and mindful awareness, were completed before the participants commenced use of the programs and following 8 weeks’ use.

RESULTS: Significant differences were found in the areas of chance and powerful others’ locus of control, and sleeping difficulties, but not in ME/CFS symptomatology overall.

CONCLUSION: The specialized online program described in this study warrants further investigation, as it appears to influence perceived control and key ME/CFS symptoms over time.

 

Source: Arroll MA, Attree EA, Marshall CL, Dancey CP. Pilot study investigating the utility of a specialized online symptom management program for individuals with myalgic encephalomyelitis/chronic fatigue syndrome as compared to an online meditation program. Psychol Res Behav Manag. 2014 Sep 2;7:213-21. doi: 10.2147/PRBM.S63193. ECollection 2014. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4159366/ (Full article)

 

The effect of relaxation therapy on autonomic functioning, symptoms and daily functioning, in patients with chronic fatigue syndrome or fibromyalgia: a systematic review

Abstract:

OBJECTIVE: To establish the effects of relaxation therapy on autonomic function, pain, fatigue and daily functioning in patients with chronic fatigue syndrome or fibromyalgia.

METHOD: A systematic literature study was performed. Using specific keywords related to fibromyalgia or chronic fatigue syndrome and relaxation therapy, the electronic databases PubMed and Web of Science were searched. Included articles were assessed for their risk of bias and relevant information regarding relaxation was extracted. The review was conducted and reported according to the PRISMA-statement.

RESULTS: Thirteen randomized clinical trials of sufficient quality were included, resulting in a total of 650 fibromyalgia patients (11 studies) and 88 chronic fatigue syndrome patients (3 studies). None of the studies reported effects on autonomic function. Six studies reported the effect of guided imagery on pain and daily functioning in fibromyalgia. The acute effect of a single session of guided imagery was studied in two studies and seems beneficial for pain relief. For other relaxation techniques (eg. muscle relaxation, autogenic training) no conclusive evidence was found for the effect on pain and functioning in fibromyalgia patients comparison to multimodal treatment programs. For fatigue a multimodal approach seemed better than relaxation, as shown in the sole three studies on chronic fatigue syndrome patients.

CONCLUSION: There is moderate evidence for the acute effect of guided imagery on pain, although the content of the visualization is a matter of debate. Other relaxation formats and the effects on functionality and autonomic function require further study.

© The Author(s) 2014.

 

Source: Meeus M, Nijs J, Vanderheiden T, Baert I, Descheemaeker F, Struyf F. The effect of relaxation therapy on autonomic functioning, symptoms and daily functioning, in patients with chronic fatigue syndrome or fibromyalgia: a systematic review. Clin Rehabil. 2015 Mar;29(3):221-33. doi: 10.1177/0269215514542635. Epub 2014 Sep 8. https://www.ncbi.nlm.nih.gov/pubmed/25200878

 

Long-term outcome of cognitive behavior therapy versus relaxation therapy for chronic fatigue syndrome: a 5-year follow-up study

Abstract:

OBJECTIVE: This study evaluated the long-term outcome of cognitive behavior therapy versus relaxation therapy for patients with chronic fatigue syndrome.

METHOD: Sixty patients who participated in a randomized controlled trial of cognitive behavior therapy versus relaxation therapy for chronic fatigue syndrome were invited to complete self-rated measures and participate in a 5-year follow-up interview with an assessor who was blind to treatment type.

RESULTS: Fifty-three patients (88%) participated in the follow-up study: 25 received cognitive behavior therapy and 28 received relaxation therapy. A total of 68% of the patients who received cognitive behavior therapy and 36% who received relaxation therapy rated themselves as “much improved” or “very much improved” at the 5-year follow-up. Significantly more patients receiving cognitive behavior therapy, in relation to those in relaxation therapy, met criteria for complete recovery, were free of relapse, and experienced symptoms that had steadily improved or were consistently mild or absent since treatment ended. Similar proportions were employed, but patients in the cognitive behavior therapy group worked significantly more mean hours per week. Few patients crossed the threshold for “normal” fatigue, despite achieving a good outcome on other measures. Cognitive behavior therapy was positively evaluated and was still used by over 80% of the patients.

CONCLUSIONS: Cognitive behavior therapy for chronic fatigue syndrome can produce some lasting benefits but is not a cure. Once therapy ends, some patients have difficulty making further improvements. In the future, attention should be directed toward ensuring that gains are maintained and extended after regular treatment ends.

 

Source: Deale A, Husain K, Chalder T, Wessely S. Long-term outcome of cognitive behavior therapy versus relaxation therapy for chronic fatigue syndrome: a 5-year follow-up study. Am J Psychiatry. 2001 Dec;158(12):2038-42. http://www.ncbi.nlm.nih.gov/pubmed/11729022

 

Cognitive behavior therapy for chronic fatigue syndrome: a randomized controlled trial

Abstract:

OBJECTIVE: Cognitive behavior therapy for chronic fatigue syndrome was compared with relaxation in a randomized controlled trial.

METHODS: Sixty patients with chronic fatigue syndrome were randomly assigned to 13 sessions of either cognitive behavior therapy (graded activity and cognitive restructuring) or relaxation. Outcome was evaluated by using measures of functional impairment, fatigue, mood, and global improvement.

RESULTS: Treatment was completed by 53 patients. Functional impairment and fatigue improved more in the group that received cognitive behavior therapy. At final follow-up, 70% of the completers in the cognitive behavior therapy group achieved good outcomes (substantial improvement in physical functioning) compared with 19% of those in the relaxation group who completed treatment.

CONCLUSIONS: Cognitive behavior therapy was more effective than a relaxation control in the management of patients with chronic fatigue syndrome. Improvements were sustained over 6 months of follow-up.

Comment in: Cognitive behavior therapy for chronic fatigue syndrome. [Am J Psychiatry. 1998]

 

Source: Deale A, Chalder T, Marks I, Wessely S. Cognitive behavior therapy for chronic fatigue syndrome: a randomized controlled trial. Am J Psychiatry. 1997 Mar;154(3):408-14. http://www.ncbi.nlm.nih.gov/pubmed/9054791