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

Parkinson's Disease Clinical Trial

— MindPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683330
• Other study ID #: PSYETH (S/F) 15/16 112
• Secondary ID: Innovation grant
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: March 2017

Study information

• Verified date: January 2019
• Source: City, University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	City University London	London

Sponsors (1)

Lead Sponsor	Collaborator
City, University of London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View 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.

Pickut B, Vanneste S, Hirsch MA, Van Hecke W, Kerckhofs E, Mariën 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-Compassion Scale (SCS)		Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Other	Philadelphia Mindfulness Scale (PHLMS)		Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Other	Experiences Questionnaire (EQ)		Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Other	Acceptance Action Questionnaire (AAQ-II)		Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Other	Subjective Well-Being questionnaire (SWB)		Baseline, Post-intervention (week 8) and Follow-up (week 20)
Other	EuroQol Five-Dimensional questionnaire (EQ-5D-3L)		Baseline, Post-intervention (week 8) and Follow-up (week 20)
Other	Visual Analogue Scale (VAS)		Baseline, Post-intervention (week 8) and Follow-up (week 20)
Other	ICEpop CAPability measure for Adults (ICECAP-A)		Baseline, Post-intervention (week 8) and Follow-up (week 20)
Other	Adult Social Care Outcomes Toolkit (ASCOT)		Baseline, Post-intervention (week 8) and Follow-up (week 20)
Primary	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	Parkinson's Disease Activities of Daily Living Scale (PADLS)		Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Secondary	Brief Pain Inventory (BPI)		Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Secondary	Fatigue Severity Scale (FSS)		Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Secondary	Insomnia Severity Index (ISI)		Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)