NCT02902692

Brief Summary

The current study will examine the effects of a brief mindfulness based intervention (BMBI) on mood, memory and attention in comparison to a wait-list control (WLC) group. Participants for the study will be 90 adults aged 50 years and above who have presented at a memory clinic within SLaM NHS Trust with subjective cognitive concerns and/or those who have received a diagnosis of mild cognitive impairment (MCI) from their memory clinic.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 16, 2016

Status Verified

April 1, 2016

Enrollment Period

11 months

First QC Date

August 31, 2016

Last Update Submit

September 12, 2016

Conditions

Keywords

briefmindfulness

Outcome Measures

Primary Outcomes (1)

  • Test of Everyday Attention

    The Test of Everyday Attention (TEA): Two subtests from the TEA (Robertson et al., 1994) will be used in the current study. Specifically, the Elevator Test will be used to measure sustained attention and the Visual Elevator Test will be used as a measure of attentional switching, and hence of cognitive flexibility. The TEA subtests are based on everyday life scenarios offering greater ecological validity. It has parallel forms which allow for repeat administration within short time periods reducing the impact of practice effects.

    Change in attention from Baseline to 1 Week

Secondary Outcomes (12)

  • Hospital Anxiety Depression Scale (HADS)

    Change in anxiety and depression from Baseline to 1 Week

  • Penn State Worry Questionnaire

    Change in worry from Baseline to 1 Week

  • Short Form Health Survey

    Change in quality of life from Baseline to 1 Week

  • The Trail Making Test Parts A&B

    Change in executive functioning from Baseline to 1 Week

  • Digit Span Task

    Change in working memory from Baseline to 1 Week

  • +7 more secondary outcomes

Study Arms (1)

Brief Mindfulness

EXPERIMENTAL

45 minute brief mindfulness intervention (lead by study investigator) on day 1 followed by 7 days of 30 minute mindfulness practice at home (without study investigator)

Other: Brief Mindfulness

Interventions

15 minutes psycho-education about mindfulness and a small experiential exercise using a raisin. Following this, participants listen to a 30minute pre-recorded sitting meditation which encourages them to focus on their breath and the sounds around them. Participants will be randomly assigned to either receive the brief mindfulness intervention immediately or will be asked to wait one week before receiving the intervention.

Brief Mindfulness

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South London and Maudsely NHS Memory Services

London, London, SE5 8AF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Rebecca Gould, PhD,DClinPsy

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pearlene Ng, BSc

CONTACT

Aisling Roche, BSc,MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 16, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

September 16, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations