Distant delivery of a mindfulness-based intervention for people with Parkinson’s disease: the study protocol of a randomised pilot trial

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

Acceptability and Feasibility of a Mindfulness Intervention Delivered via Videoconferencing for People With Parkinson’s

“…More details on the protocol of the study have previously been published. 28 All participants completed written informed consent.…”

Prioritising target non-pharmacological interventions for research in Parkinson’s disease: achieving consensus from key stakeholders

“…The efficacy of third wave therapies such as mindfulness, cognitive behaviour therapy and stress management is increasingly being tested for a range of non-motor symptoms in PD [19][20][21][27][28][29] with some positive preliminary results. Large, controlled trials with longer follow up periods are needed.…”

“…A challenge of providing these interventions is often one of resource, particularly when a trained therapist is required to implement an intervention. Despite the recent proliferation of online interventions in Parkinson's [27,28] which have clear practical benefits, there was a consensus that an element of face-to-face contact was required in intervention delivery. It is essential to carefully balance the preferences of people with Parkinson's with the practicalities of delivering cost-effective interventions to large groups.…”

“…Consequently, finding innovative ways to implement the intervention whilst still maintaining human contact, rather than taking a purely digital approach, is paramount. Recent work exploring the use of skype conferencing to deliver mindfulness interventions [27,30] or the use of lay facilitators to deliver interventions across conditions may be important avenues for further research [31][32][33].…”

Exploring Nonmotor Neuropsychiatric Manifestations of Parkinson Disease in a Comprehensive Care Setting

“…Other trials for therapy involving body awareness training for the treatment of wearing off-related anxiety and a mindfulness-based exercise have shown that these modalities are helpful in balance and well-being. 32,33 Serial electroconvulsive therapy (ECT) has not been well studied but was found to be effective in a case study of severe anxiety in patients with PD. 34…”