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

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ClinicalTrials.gov Identifier: NCT02683330
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Angeliki Bogosian, 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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: Mindfulness-based intervention (MBI) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness-based Intervention for People Affected by Parkinson's Disease: A Distant-delivered Randomised Pilot Trial
Actual Study Start Date : January 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683330


Locations
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United Kingdom
City University London
London, United Kingdom, EC1V 0HB
Sponsors and Collaborators
City, University of London
Investigators
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Principal Investigator: Angeliki Bogosian, PhD City, University of London
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Angeliki Bogosian, Lecturer in Psychology, City, University of London
ClinicalTrials.gov Identifier: NCT02683330    
Other Study ID Numbers: PSYETH (S/F) 15/16 112
Innovation grant: K-1409 ( Other Grant/Funding Number: Parkinson's UK )
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Angeliki Bogosian, City, University of London:
PD
Parkinson's
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases