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

City, University of London

Status: Completed

Conditions: Parkinson's Disease

Treatments: Behavioral: Mindfulness-based intervention (MBI)

Study type: Interventional

Funder types: Other

Identifiers

NCT02683330

Innovation grant: K-1409 (Other Grant/Funding Number)

PSYETH (S/F) 15/16 112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Mindfulness-based intervention (MBI)

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-based intervention (MBI)

Wait-list control (WLC)

No Intervention group

Description:

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.