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

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Behavioral: Mindfulness-based intervention (MBI)

• Registration Number: NCT02683330
• Lead Sponsor: City, University of London

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-17
• Primary Completion: 2016-10
• Study Completion: 2017-03
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-based intervention (MBI)	Mindfulness-based intervention (MBI)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Parkinson's Disease Activities of Daily Living Scale (PADLS)	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)
Brief Pain Inventory (BPI)	Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)

Trial Locations

Locations (1)

City University London; 🇬🇧 London, United Kingdom