Clinical trial NCT02683330: Distant Delivery of a Mindfulness-based Intervention for People Affected by Parkinson's Disease
Official title: Mindfulness-based Intervention for People Affected by Parkinson's Disease: A Distant-delivered Randomised Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: PD
Parkinson's
Lead sponsor: City, University of London
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline Hospital Anxiety and Depression Scale (HADS) at 4, 8 and 20 weeks
timeFrame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20).
Secondary outcomes:
measure: Parkinson's Disease Activities of Daily Living Scale (PADLS)
timeFrame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
measure: Brief Pain Inventory (BPI)
timeFrame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
measure: Fatigue Severity Scale (FSS)
timeFrame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Other outcomes:
measure: Self-Compassion Scale (SCS)
timeFrame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
measure: Philadelphia Mindfulness Scale (PHLMS)
timeFrame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
measure: Experiences Questionnaire (EQ)
timeFrame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
measure: Acceptance Action Questionnaire (AAQ-II)
timeFrame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
measure: Subjective Well-Being questionnaire (SWB)
timeFrame: Baseline, Post-intervention (week 8) and Follow-up (week 20)
measure: EuroQol Five-Dimensional questionnaire (EQ-5D-3L)
timeFrame: Baseline, Post-intervention (week 8) and Follow-up (week 20)
measure: Visual Analogue Scale (VAS)
timeFrame: Baseline, Post-intervention (week 8) and Follow-up (week 20)
measure: ICEpop CAPability measure for Adults (ICECAP-A)
timeFrame: Baseline, Post-intervention (week 8) and Follow-up (week 20)
measure: Adult Social Care Outcomes Toolkit (ASCOT)
timeFrame: Baseline, Post-intervention (week 8) and Follow-up (week 20)
Locations:
city: London
country: United Kingdom
facility: City University London
Study officials:
affiliation: City, University of London
name: Angeliki Bogosian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.