NCT03195985

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

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

December 2, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

5 months

First QC Date

December 2, 2016

Last Update Submit

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

EXPERIMENTAL

Mindfulness intervention of 4 weeks

Other: Mindfulness-based intervention

"Age Well" psycho-education course

ACTIVE COMPARATOR

4-week active control condition

Other: Age Well psycho-education

Interventions

A shortened, 4 week mindfulness intervention course based on the original 8 week mindfulness-based stress reduction course by Jon Kabat-Zinn

Mindfulness-based Intervention

4-week active control condition aimed at psycho-education regarding healthy ageing

"Age Well" psycho-education course

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

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

Study Sites (2)

Chelsea and Westminster Hospital NHS Trust

London, sw10 9nh, United Kingdom

Location

The Magill Department of Anaesthesia, Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

Location

Study Officials

  • Trudi Edginton, PhD

    Chelsea & Westminster Hospital, London UK

    PRINCIPAL INVESTIGATOR

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

Locations