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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Mindfulness-based intervention (MBI)
Sponsored by
City, University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring PD, Parkinson's

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • City University London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness-based intervention (MBI)

Wait-list control (WLC)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Parkinson's Disease Activities of Daily Living Scale (PADLS)
Brief Pain Inventory (BPI)
Fatigue Severity Scale (FSS)
Insomnia Severity Index (ISI)

Full Information

First Posted
February 8, 2016
Last Updated
January 31, 2019
Sponsor
City, University of London
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1. Study Identification

Unique Protocol Identification Number
NCT02683330
Brief Title
Distant Delivery of a Mindfulness-based Intervention for People Affected by Parkinson's Disease
Acronym
MindPD
Official Title
Mindfulness-based Intervention for People Affected by Parkinson's Disease: A Distant-delivered Randomised Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
City, University of London

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
PD, Parkinson's

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based intervention (MBI)
Arm Type
Experimental
Arm 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.
Arm Title
Wait-list control (WLC)
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based intervention (MBI)
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline Hospital Anxiety and Depression Scale (HADS) at 4, 8 and 20 weeks
Description
HADS also assessed at Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20) time points.
Time Frame
Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20).
Secondary Outcome Measure Information:
Title
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)
Title
Brief Pain Inventory (BPI)
Time Frame
Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Title
Fatigue Severity Scale (FSS)
Time Frame
Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Title
Insomnia Severity Index (ISI)
Time Frame
Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Other Pre-specified Outcome Measures:
Title
Self-Compassion Scale (SCS)
Time Frame
Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Title
Philadelphia Mindfulness Scale (PHLMS)
Time Frame
Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Title
Experiences Questionnaire (EQ)
Time Frame
Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Title
Acceptance Action Questionnaire (AAQ-II)
Time Frame
Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Title
Subjective Well-Being questionnaire (SWB)
Time Frame
Baseline, Post-intervention (week 8) and Follow-up (week 20)
Title
EuroQol Five-Dimensional questionnaire (EQ-5D-3L)
Time Frame
Baseline, Post-intervention (week 8) and Follow-up (week 20)
Title
Visual Analogue Scale (VAS)
Time Frame
Baseline, Post-intervention (week 8) and Follow-up (week 20)
Title
ICEpop CAPability measure for Adults (ICECAP-A)
Time Frame
Baseline, Post-intervention (week 8) and Follow-up (week 20)
Title
Adult Social Care Outcomes Toolkit (ASCOT)
Time Frame
Baseline, Post-intervention (week 8) and Follow-up (week 20)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angeliki Bogosian, PhD
Organizational Affiliation
City, University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
City University London
City
London
ZIP/Postal Code
EC1V 0HB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26101690
Citation
Pickut B, Vanneste S, Hirsch MA, Van Hecke W, Kerckhofs E, Marien P, Parizel PM, Crosiers D, Cras P. Mindfulness Training among Individuals with Parkinson's Disease: Neurobehavioral Effects. Parkinsons Dis. 2015;2015:816404. doi: 10.1155/2015/816404. Epub 2015 May 26.
Results Reference
background
PubMed Identifier
8503796
Citation
Brandt J, Welsh KA, Breitner JC, Folstein MF, Helms M, Christian JC. Hereditary influences on cognitive functioning in older men. A study of 4000 twin pairs. Arch Neurol. 1993 Jun;50(6):599-603. doi: 10.1001/archneur.1993.00540060039014.
Results Reference
background
Citation
Cash, T. V., et al. (2015). Pilot Study of a Mindfulness-Based Group Intervention for Individuals with Parkinson's Disease and Their Caregivers. Mindfulness 1-11.
Results Reference
background
PubMed Identifier
28116120
Citation
Bogosian A, Hurt CS, Vasconcelos E Sa D, Hindle JV, McCracken L, Cubi-Molla P. Distant delivery of a mindfulness-based intervention for people with Parkinson's disease: the study protocol of a randomised pilot trial. Pilot Feasibility Stud. 2017 Jan 16;3:4. doi: 10.1186/s40814-016-0117-4. eCollection 2017.
Results Reference
derived

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

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