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Completed

NCT Number: NCT02683330

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City University London

London, EC1V 0HB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Intervention (MBI)

Behavioral

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.

Primary outcomes

  1. Change from baseline Hospital Anxiety and Depression Scale (HADS) at 4, 8 and 20 weeks

    Time frame: 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 outcomes

  1. Parkinson's Disease Activities of Daily Living Scale (PADLS)

    Time frame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)

  2. Brief Pain Inventory (BPI)

    Time frame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)

  3. Fatigue Severity Scale (FSS)

    Time frame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)

  4. Insomnia Severity Index (ISI)

    Time frame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)

Other outcomes

  1. Self-Compassion Scale (SCS)

    Time frame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)

  2. Philadelphia Mindfulness Scale (PHLMS)

    Time frame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)

  3. Experiences Questionnaire (EQ)

    Time frame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)

  4. Acceptance Action Questionnaire (AAQ-II)

    Time frame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)

  5. Subjective Well-Being questionnaire (SWB)

    Time frame: Baseline, Post-intervention (week 8) and Follow-up (week 20)

  6. EuroQol Five-Dimensional questionnaire (EQ-5D-3L)

    Time frame: Baseline, Post-intervention (week 8) and Follow-up (week 20)

  7. Visual Analogue Scale (VAS)

    Time frame: Baseline, Post-intervention (week 8) and Follow-up (week 20)

  8. ICEpop CAPability measure for Adults (ICECAP-A)

    Time frame: Baseline, Post-intervention (week 8) and Follow-up (week 20)

  9. Adult Social Care Outcomes Toolkit (ASCOT)

    Time frame: Baseline, Post-intervention (week 8) and Follow-up (week 20)

Sponsors and collaborators

Lead sponsor

City, University of London

Other

Registry information

Official study title

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

Acronym: MindPD

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Feb 17, 2016
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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