Distant Delivery of a Mindfulness-based Intervention for People Affected by Parkinson's Disease

Study Overview
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Brief Summary
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Psychological difficulties, especially depression and anxiety are the most prevalent non-motor symptoms in Parkinson's Disease (PD). Pharmacological treatments are not as effective in PD. Mindfulness courses have received increased popularity and recognition as an effective way to manage emotional states, and there is ever growing findings of the effectiveness of mindfulness courses for people with long-term medical conditions. Two small pilot studies have indicated that mindfulness courses can be helpful for people with PD in improving symptoms of depression, language functioning and motor symptoms. The investigators propose to deliver these courses remotely, through Skype video conferences, to make it more accessible for people with mobility limitations and people who live in rural areas.

Detailed Description
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This study will employ a mixed-methods design, with an experimental randomised control trial followed by a qualitative design. Sixty participants will be randomly assigned to the 8-week mindfulness course (n=30) or a wait-list control group (n=30). Block randomisation will be used and the randomisation scheme will be generated using the randomisation.com website. One-hour sessions will be delivered to groups of 5 people using Skype video-conferencing. As this is a pilot study analyses will largely be descriptive. Further, inferential analyses using mixed modelling will be conducted by intention-to-treat. At the end of the intervention, the investigators will interview the participants of the mindfulness group about their experiences of the course.

Official Title
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Mindfulness-based Intervention for People Affected by Parkinson's Disease: A Distant-delivered Randomised Pilot Trial

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Behavioral: Mindfulness-based intervention (MBI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be diagnosed with PD according to PD Brain Bank criteria by a neurologist or geriatrician have a computer and internet access at home, since the course will be delivered via Skype be able to communicate in English fluently be stabilised on mood altering medication and/or Parkinson's medication for a month Exclusion Criteria: have severe cognitive impairment that would make participation in the mindfulness sessions and home practice of mindful meditation problematic or distressing. This will be assessed using the Telephone Interview for Cognitive Status-Modified (TICS-M, Brandt et al., 1993). have severe psychiatric conditions (e.g. psychosis, drug/ alcohol addiction) that can potentially risk failure in the treatment or limit participation in the course have severe hearing impairment are currently participating in other psychological therapies have prior formal training in mindfulness methods or current meditation practice

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based intervention (MBI)<br>Participants randomly assigned to the MBI group will receive 8 sessions over an 8-week period. The sessions will last 1 hour and will be held via video-conference through Skype, an online application. | Behavioral: Mindfulness-based intervention (MBI)<br>* MBI consists of 8 sessions and will cover becoming aware of emotions, thoughts and physical sensations, decentering and acceptance. Recordings of the body scan, a sitting meditation and a mindful movement meditation will be provided for daily home practice. Special care will be taken to address safety in the context of PD, and to adapt meditations to the physical limitations of PD.<br>|
| No Intervention: Wait-list control (WLC)<br>Participants randomly assigned to the WLC group will be discouraged from any new mindfulness related activities during the trial. The WLC group will be offered the opportunity to take part in the MBI at the end of the 20-week follow-up. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Hospital Anxiety and Depression Scale (HADS) at 4, 8 and 20 weeks | HADS also assessed at Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20) time points. | Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parkinson's Disease Activities of Daily Living Scale (PADLS) |  | Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20) | 
| Brief Pain Inventory (BPI) |  | Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20) | 
| Fatigue Severity Scale (FSS) |  | Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20) | 
| Insomnia Severity Index (ISI) |  | Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD, Parkinson's