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

January 31, 2019 updated by: Angeliki Bogosian, City, University of London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, EC1V 0HB
        • City University London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Mindfulness-based intervention (MBI)
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.
No Intervention: Wait-list control (WLC)
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20).

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Brief Pain Inventory (BPI)
Time Frame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Fatigue Severity Scale (FSS)
Time Frame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Insomnia Severity Index (ISI)
Time Frame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)

Other Outcome Measures

Outcome Measure
Time Frame
Self-Compassion Scale (SCS)
Time Frame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Philadelphia Mindfulness Scale (PHLMS)
Time Frame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Experiences Questionnaire (EQ)
Time Frame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Acceptance Action Questionnaire (AAQ-II)
Time Frame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Subjective Well-Being questionnaire (SWB)
Time Frame: Baseline, Post-intervention (week 8) and Follow-up (week 20)
Baseline, Post-intervention (week 8) and Follow-up (week 20)
EuroQol Five-Dimensional questionnaire (EQ-5D-3L)
Time Frame: Baseline, Post-intervention (week 8) and Follow-up (week 20)
Baseline, Post-intervention (week 8) and Follow-up (week 20)
Visual Analogue Scale (VAS)
Time Frame: Baseline, Post-intervention (week 8) and Follow-up (week 20)
Baseline, Post-intervention (week 8) and Follow-up (week 20)
ICEpop CAPability measure for Adults (ICECAP-A)
Time Frame: Baseline, Post-intervention (week 8) and Follow-up (week 20)
Baseline, Post-intervention (week 8) and Follow-up (week 20)
Adult Social Care Outcomes Toolkit (ASCOT)
Time Frame: Baseline, Post-intervention (week 8) and Follow-up (week 20)
Baseline, Post-intervention (week 8) and Follow-up (week 20)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City, University of London

Investigators

  • Principal Investigator: Angeliki Bogosian, PhD, City, University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

February 8, 2016

First Submitted That Met QC Criteria

February 16, 2016

First Posted (Estimate)

February 17, 2016

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSYETH (S/F) 15/16 112
  • Innovation grant: K-1409 (Other Grant/Funding Number: Parkinson's UK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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