NCT02683330

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

9 months

First QC Date

February 8, 2016

Last Update Submit

January 31, 2019

Conditions

Parkinson's Disease

Keywords

PDParkinson's

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20).

Secondary Outcomes (4)

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

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

  • Brief Pain Inventory (BPI)

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

  • Fatigue Severity Scale (FSS)

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

  • Insomnia Severity Index (ISI)

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

Other Outcomes (9)

  • Self-Compassion Scale (SCS)

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

  • Philadelphia Mindfulness Scale (PHLMS)

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

  • Experiences Questionnaire (EQ)

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

  • +6 more other outcomes

Study Arms (2)

Mindfulness-based intervention (MBI)

EXPERIMENTAL

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)

Wait-list control (WLC)

NO INTERVENTION

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.

Interventions

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.

Mindfulness-based intervention (MBI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City University London

London, EC1V 0HB, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 26101690BACKGROUND

  • 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.

    PMID: 8503796BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 28116120DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Angeliki Bogosian, PhD

    City, University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Psychology

Study Record Dates

First Submitted

February 8, 2016

First Posted

February 17, 2016

Study Start

January 1, 2016

Primary Completion

October 1, 2016

Study Completion

March 1, 2017

Last Updated

February 1, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)