Mindfulness in Old Adults With Subjective Cognitive Complaints
Managing Stress and Cognitive Difficulties With a Short Mindfulness-based Intervention in Old Adults With Subjective Cognitive Complaints
1 other identifier
interventional
20
1 country
2
Brief Summary
The study will focus on measuring stress, rumination and cognitive function across three time points in old adults with subjective cognitive complaints via a 4-week short mindfulness intervention, as compare to an active control condition (psycho-education course "ge Well"). This is a pilot study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2017
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2016
CompletedFirst Posted
Study publicly available on registry
June 22, 2017
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedMarch 13, 2018
March 1, 2018
5 months
December 2, 2016
March 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in cortisol levels between the two MCI groups over time
assessed by collecting hair from the vertex posterior for stress hormone analysis
One month
Secondary Outcomes (2)
Changes in anxiety over time
One month
Changes in verbal learning and memory over time
One month
Study Arms (2)
Mindfulness-based Intervention
EXPERIMENTALMindfulness intervention of 4 weeks
"Age Well" psycho-education course
ACTIVE COMPARATOR4-week active control condition
Interventions
A shortened, 4 week mindfulness intervention course based on the original 8 week mindfulness-based stress reduction course by Jon Kabat-Zinn
4-week active control condition aimed at psycho-education regarding healthy ageing
Eligibility Criteria
You may qualify if:
- All willing and consenting patients over the age of 65
- Patients who have been admitted to the hospital and who have been formally diagnosed with MCI at the Memory Clinic
- Patients with hair at the posterior vertex
- Patients with fluent English
- Patients who can commit to the entire length of the study
- Patients with interest in mindfulness
You may not qualify if:
- Being under 65 years of age
- Presence of any psychiatric disorders,
- Presence of myopathy
- Presence of atherosclerosis
- Use of steroids
- Having undergone chemotherapy
- heart disorder
- dementia
- head injury
- advanced neurodegenerative disease
- any patient having had dyed their hair less than one week prior to the first cortisol sampling
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chelsea and Westminster NHS Foundation Trustlead
- University of Westminstercollaborator
- Imperial College Londoncollaborator
Study Sites (2)
Chelsea and Westminster Hospital NHS Trust
London, sw10 9nh, United Kingdom
The Magill Department of Anaesthesia, Chelsea and Westminster Hospital
London, SW10 9NH, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Trudi Edginton, PhD
Chelsea & Westminster Hospital, London UK
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant in Anaesthesia and Intensive Care
Study Record Dates
First Submitted
December 2, 2016
First Posted
June 22, 2017
Study Start
July 1, 2017
Primary Completion
December 1, 2017
Study Completion
February 1, 2018
Last Updated
March 13, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share