Abstract
BackgroundPsychological difficulties, especially depression and anxiety, are the most prevalent non-motor symptoms in Parkinson’s disease. Pharmacological treatments for these conditions appear relatively ineffective in Parkinson’s disease. Mindfulness courses are increasingly popular and recognised as effective for managing emotional states, and there is growing evidence for the effectiveness of mindfulness courses for people with long-term medical conditions. With this exploratory pilot trial, we want to assess the feasibility of the procedures and processes, including recruitment, most appropriate outcome measure(s), acceptability of type and number of measures, potential nocebo effects, and potential effectiveness and cost-effectiveness of a specially adapted distance-delivered mindfulness-based intervention in people affected by Parkinson’s disease.Methods/DesignThis is a pilot two-arm randomised parallel group controlled trial. Sixty participants who meet eligibility criteria will be randomly assigned either to an 8-week mindfulness-based intervention group or a wait-list control group. The mindfulness intervention will include 1-h weekly sessions delivered by a health psychologist trained to facilitate mindfulness courses. Participants in both groups will complete standardised questionnaires assessing anxiety, depression, pain, insomnia, fatigue, and daily activities at four time points (baseline, 4, 8, and 20 weeks). The analysis will also consider potential mechanisms of change, such as acceptance, self-compassion, and tolerance of uncertainty, as well as health economic outcomes. Participants’ experiences of the mindfulness interventions will be explored via in-depth interviews.DiscussionA mindfulness-based intervention for people with Parkinson’s delivered remotely, through Skype group videoconferences, may represent a viable, more accessible, intervention for people with mobility limitations and people who live in rural areas. The trial will provide important information about the feasibility, potential efficacy and cost-effectiveness, and acceptability of the intervention as well as mechanisms of psychosocial adjustment. The results of this pilot trial will help us design a phase III trial to assess efficacy of an online mindfulness-based intervention in Parkinson’s disease and evaluate significance.Trial registrationClinicalTrials.gov, NCT02683330
Highlights
Psychological difficulties, especially depression and anxiety, are the most prevalent non-motor symptoms in Parkinson’s disease
We will explore different ways to deliver group psychological interventions and we will enrich our knowledge on the specific needs and challenges faced by people affected by Parkinson’s disease (PD) as well as how best to address these needs
The total Hospital Anxiety and Depression Scale (HADS) [31] score may not be the most appropriate tool to detect caseness of depression and anxiety [57]. It was chosen since HADS measures anxiety and depression without confounding by somatic symptoms of the physical disorder, in contrast to other depression and anxiety scales that include items like insomnia, retardation of psychomotor, tremor, dry mouth, muscle aches, loss of energy, and fatigue
Summary
Mindfulness-based interventions have been shown to effectively reduce anxiety, depression, and pain in patients with chronic physical illnesses, including PD [14]. Mindfulness-based interventions have been traditionally delivered in a face-to-face group setting [55] This pilot trial will look at assisting psychological adjustment for people with PD and is conducted in preparation of an efficacy study for an online MBI in PD. We will explore the role of different ‘active ingredients’ of mindfulness-based approaches such as acceptance, self-compassion, decentering, and cultivating mindfulness skills to determine how mindfulness interventions work and which are the most important components of these interventions regarding changes in outcome measure. This pilot trial will provide some indication regarding the cost-effectiveness of the intervention and its acceptability to patients.
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