Parkinson's DiseaseMindPDNCT02683330
Distant Delivery of a Mindfulness-based Intervention for People Affected by Parkinson's Disease
A study testing Mindfulness-based intervention (MBI) in people with Parkinson's Disease, run by City, University of London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Mindfulness-based intervention (MBI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness-based Intervention for People Affected by Parkinson's Disease: A Distant-delivered Randomised Pilot Trial
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Mindfulness-based intervention (MBI)
- Keywords
- PD, Parkinson's
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based intervention (MBI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Brief Pain Inventory (BPI)
Measured: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Fatigue Severity Scale (FSS)
Measured: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Insomnia Severity Index (ISI)
Measured: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- City, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angeliki Bogosian, City, University of London
- Investigators
- Angeliki Bogosian, PhD, Principal investigator, City, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683330
- Sponsor's protocol ID
- PSYETH (S/F) 15/16 112
- Other IDs
- Innovation grant: K-1409
- Acronym
- MindPD
- Status last verified
- Jan 2019
- First submitted
- 8 Feb 2016
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26101690Brandt 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.
PubMed 8503796Cash, 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.
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.
PubMed 28116120
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Intervention for People Affected by Parkinson's Disease: A Distant-delivered Randomised Pilot Trial
- ClinicalTrials.gov ID
- NCT02683330
- Acronym / sponsor ID
- MindPD / PSYETH (S/F) 15/16 112
- Conditions
- Parkinson's Disease
- Keywords
- PD, Parkinson's
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- City, University of LondonUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based intervention (MBI) | Experimental | Behavioral: 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mindfulness-based intervention (MBI) |
Primary outcome
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.
4 secondary outcomes
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)
Brief Pain Inventory (BPI)
Time frame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Fatigue Severity Scale (FSS)
Time frame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Insomnia Severity Index (ISI)
Time frame: Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Background: PubMed 26101690Pickut 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.
- Background: PubMed 8503796Brandt 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.
- BackgroundCash, 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.
- Derived from this study: PubMed 28116120Bogosian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angeliki Bogosian, PhD principal investigator
City, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based intervention (MBI) in people with Parkinson's Disease, run by City, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02683330, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.