Mindfulness-based interventions for people with multiple sclerosis

Simpson, Robert John (2017) Mindfulness-based interventions for people with multiple sclerosis. PhD thesis, University of Glasgow.

Abstract

Background:
Multiple sclerosis is a chronic neurodegenerative condition that can significantly impair length and quality of life. Comorbidity (the presence of additional chronic conditions) has been reported as common in multiple sclerosis and is associated with diagnostic delays, increased disability, and higher mortality rates in people with multiple sclerosis. Multiple sclerosis is a stressful condition, with a highly unpredictable disease course, often necessitating complex and unpleasant treatment regimens. Stress in multiple sclerosis raises the risk of significant mental illness, impacts negatively on quality of life, and may be associated with an increased risk of disease relapse (although the evidence supporting this latter link is limited). Current stress management strategies in multiple sclerosis are limited, with a recent systematic review identifying only one high quality study supporting the use of cognitive behavioural therapy. Mindfulness-based interventions have been demonstrated to help with stress management in other long-term conditions, such as anxiety and recurrent depression. Very little is known about the use and effectiveness of mindfulness-based interventions in people with multiple sclerosis.

Methods:
This thesis followed the United Kingdom Medical Research Council guidance (2008) on developing and evaluating complex interventions. The research commenced with an epidemiological study of comorbidity in multiple sclerosis using a nationally representative cross-sectional primary care database from Scotland (n=1,268,859, of whom 3,826 had multiple sclerosis). The analysis focused on 39 other long-term conditions, comparing prevalence rates for people with multiple sclerosis aged 25 or over versus matched controls, controlling for age, sex, and socio-economic status. Results are presented as odds ratios (ORs) with 95% confidence intervals (95%CI), and p values.
Secondly, a systematic review was conducted to evaluate the evidence for the effectiveness of mindfulness-based interventions in people with multiple sclerosis in terms of reducing perceived stress and other relevant secondary outcomes, including mental health, physical health, and quality of life. Study quality was determined using the Cochrane Collaboration quality assessment tool.
Following this, a phase-2 randomised controlled trial was undertaken, testing the feasibility of delivering a Mindfulness-Based Stress Reduction course to a group of (n=25) people with multiple sclerosis versus wait-list control (n=25). Primary patient report outcome measures were perceived stress (Perceived Stress Scale-10) and health-related quality of life (EQ-5D-5L). Secondary patient report outcomes included the Multiple Sclerosis Quality of Life Inventory, mindfulness (the Mindful Attention Awareness Scale), self-compassion (the Self-Compassion Scale-short form), and emotional lability (the Emotional Lability Questionnaire). Results are reported in ‘p’ values and effect sizes (ES - Cohen’s ‘d’) with 95%CIs.
A linked qualitative process evaluation nested within the randomised controlled trial assessed Mindfulness-Based Stress Reduction instructor and participant experience through semi-structured interviews with 17 participants and the two instructors. In order to organise and summarise the data, the Framework Approach to thematic analysis was employed. The emergent themes from the thematic analysis were then scrutinised under the theoretical ‘lens’ of Normalisation Process Theory, as a means of conceptualising the data and assessing potential implementation issues.

Results:
Epidemiology People with multiple sclerosis in Scotland aged 25 years or over were more than twice as likely to have comorbidity of one or more long-term conditions than matched controls (OR 2.44; 95%CI 2.26-2.64). Mental health comorbidity was particularly prevalent in people with multiple sclerosis, being almost three times as common compared with controls (OR 2.94; 95% CI 2.75-3.14). Depression (OR 3.30; 95%CI 3.10 – 3.57) and anxiety (OR 3.18; 95%CI 2.89 – 3.50) were particularly common. As the number of physical health conditions rose in people with multiple sclerosis, so too did the prevalence of mental health comorbidity. Certain neurological conditions (epilepsy, pain, migraine, visual impairment) and gastrointestinal conditions (constipation, irritable bowel syndrome) were also more common in people with multiple sclerosis.
Systematic review Three published controlled outcome studies using mindfulness-based interventions in people with multiple sclerosis were identified. Only one study was of high methodological quality. The findings suggested that mindfulness-based interventions may improve quality of life, mental health (anxiety and depression), and some physical outcome measures (fatigue, pain, standing balance), with effects lasting for up to six months post-treatment. Meta-analysis was not possible due to heterogeneity amongst studies. Since the systematic review was conducted, three further studies of mindfulness-based interventions in people with multiple sclerosis have been published. These studies were generally of low methodological quality, but they did add some further evidence that such interventions can improve scores for anxiety, depression, stress, pain, fatigue, co-ordination, balance, and quality of life. However, the overall weight of evidence supporting the use of mindfulness-based interventions in people with multiple sclerosis remains limited.
Randomised controlled trial The recruitment target of 50 participants was met within the pre-defined three-month window. Outcome measure completion rates were good immediately post-intervention (90%) and at study end-point, three months post-intervention (88%). However, participant attendance at the weekly 2.5 hours mindfulness sessions was only 60%, and average home practice times were less than the suggested amount of 45 minutes, six days per week.
In adjusted models (controlling for age, sex, deprivation, previous yoga/meditation experience) for primary patient-report outcomes immediately post-intervention, perceived stress scores improved with a large overall effect size (ES 0.93; p<0.01), and large effects were also evident on subscales of negative stress appraisal (ES 0.82; p<0.05), and on stress resilience items (ES 0.92; p<0.05). Quality of life scores showed only very small improvements overall (ES 0.17; p=0.48), with only the anxiety/depression subscale showing a small effect size immediately post-intervention (ES 0.41; p=0.16).
Secondary patient report outcomes showed improvements with large effect sizes immediately post-intervention in scores for depression (ES 1.35; p<0.05), positive affect (ES 0.87; p=0.13), anxiety (ES 0.85; p=0.05), and self-compassion (ES 0.80; p<0.01).
At study endpoint three-months post-intervention, adjusted models revealed that the beneficial effects on perceived stress and improvements in stress resilience had diminished to small effect sizes (ES 0.26; p=0.39, and ES 0.46; p=0.05 respectively). Quality of life scores showed negligible improvement overall (ES 0.08; p=0.71), but a small beneficial effect persisted on the anxiety/depression subscale (ES 0.26; p=0.42).
For secondary patient-report outcomes at study endpoint, the large effect sizes found immediately post-intervention for depression were no longer apparent (ES 0.01; p=1.00), but remained evident for positive affect (ES 0.90; p=0.54), anxiety (ES 0.82; p=0.15), and self-compassion (ES 0.83; p<0.05), with large effect size improvements also noted for mindfulness (ES 1.13; p<0.001) and prospective memory (ES 0.81; p<0.05).
Qualitative evaluation: People who came on the Mindfulness-Based Stress Reduction course generally reported benefits, namely reduced stress, less pain, and improved relationships. Four main themes were identified in the thematic analysis: 1) ‘Coming together for the course’ 2) ‘Doing the work’ 3) ‘Getting it, or not’, and 4) ‘Moving forward and improving the course’. Using the ‘lens’ of Normalisation Process Theory, these themes were further scrutinised, and potential barriers and facilitators to taking part were identified. Recommendations derived from this process included: a) inclusion of a pre-course orientation session in future courses to address participant expectations; b) making the course environment more disability-friendly; c) making the course materials more multiple sclerosis- and ability-appropriate; and d) embedding routine monitoring into future courses.

Conclusions:
The work of this thesis has demonstrated that among multiple sclerosis patients in Scotland, both physical and mental health comorbidities are common. There is limited published evidence supporting the use of mindfulness-based interventions in people with multiple sclerosis, but some indication that these interventions may improve anxiety, depression, stress, pain, fatigue, balance, co-ordination, and quality of life. Findings from the exploratory phase-2 randomised controlled trial suggest that delivering Mindfulness-Based Stress Reduction to people with multiple sclerosis under trial conditions is feasible with some evidence of likely effectiveness. Mindfulness-Based Stress Reduction generally appears to be acceptable, accessible, and implementable for people with multiple sclerosis, but an orientation session should be provided pre-course, and course materials may need to be carefully tailored to meet the complex needs of more disabled individuals with multiple sclerosis. These optimisation processes may lead to improved engagement and adherence with the mindfulness practices, which could potentially lead to more stable treatment effects. Prior to proceeding to a phase-3 efficacy trial, such modifications should be piloted. More high quality research is required before definitive recommendations on the effectiveness of mindfulness-based interventions for people with multiple sclerosis can be made.

• Item Type: Thesis (PhD)
• Qualification Level: Doctoral
• Keywords: Mindfulness, multiple sclerosis, stress, comorbidity, complex interventions, systematic review, randomised controlled trial, qualitative process evaluation.
• Subjects: B Philosophy. Psychology. Religion > BF Psychology; R Medicine > RC Internal medicine > RC0321 Neuroscience. Biological psychiatry. Neuropsychiatry; R Medicine > RZ Other systems of medicine
• Colleges/Schools: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > General Practice and Primary Care
• Supervisor's Name: Mercer, Professor Stewart W. and Mair, Professor Frances S.
• Date of Award: 2017
• Depositing User: Dr Robert Simpson
• Unique ID: glathesis:2017-7893
• Copyright: Copyright of this thesis is held by the author.
• Date Deposited: 07 Feb 2017 16:10
• Last Modified: 16 Mar 2017 15:32
• URI: https://theses.gla.ac.uk/id/eprint/7893

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