search
Back to results

Mindfulness for Older Adults With Cognitive Concerns

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Brief Mindfulness
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mild Cognitive Impairment focused on measuring brief, mindfulness

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:People aged 50 years and older with subjective memory concerns (SMC) and/or those who meet criteria for amnestic mild cognitive impairment (MCI) who have been seen by one of the three SLAM memory services (i.e. Croydon Memory Service; Southwark and Lambeth Memory Service; and Lewisham Memory Service) in the past three months. Participants must be able to give informed consent to participate.

-

Exclusion Criteria: Diagnosis of dementia or multi-domain mild cognitive impairment, intellectual disability, current substance misuse, a current diagnosis of epilepsy or another neurodegenerative disorder (such as Parkinson's), a history of brain injury or stroke, a severe and enduring mental health disorder (e.g. severe depression or anxiety, personality disorder, schizophrenia, schizoaffective disorder, bipolar affective disorder), active suicidal ideation, severe sensory impairment that would significantly impair a person's ability to engage in the intervention.

-

Sites / Locations

  • South London and Maudsely NHS Memory ServicesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brief Mindfulness

Arm Description

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hospital Anxiety Depression Scale (HADS)
The HADS consists of two subscales measuring depression and anxiety respectively. Each subscale consists of seven items and responses on the items are based on the relative frequency of symptoms over the past week using a four point Likert scale ranging from 0 (not at all) to 3 (very often indeed). Higher scores indicate higher levels of depression and anxiety, and scores of about 10 on each subscale indicate clinical significance.
Penn State Worry Questionnaire
Penn State Worry Questionnaire: The PSWQ is a 16-item measure of worry that has shown adequate internal consistency and convergent validity in elderly patients with GAD and controls( Beck et al., 1995 and Stanley et al., 2001). It uses a Likert rating from 1 (not at all typical of me) to 5 (very typical of me).
Short Form Health Survey
Short-Form Health Survey (SF-36): The physical and mental summary scores of the Short Form Health Survey (SF-36) (Van de Zee et al., 1993) are used to measure quality of life related to physical and mental aspects. The SF-36 is composed of 36 items measuring health across eight dimensions: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, pain, mental health, vitality, and general health perception. These eight subscales can be summarized into one physical and one mental component summary score. Each dimension score ranges from 0-100. Higher scores indicate better health-related quality of life.
The Trail Making Test Parts A&B
The Trail Making Test (TMT; Army Individual Test Battery, 1944) is a commonly used neuropsychological test of visual attention and task switching. It consists of 2 parts: part A asks participants to connect a series of numbers in ascending order on a page, while part B requires participants to draw a line alternating between ascending numbers and letters. Part A is used primarily to capture processing speed whereas Part B requires more complex attention shifting, planning, and concentration, and is, thus, considered a valid index of executive control. The time taken to complete the task is the primary performance outcome
Digit Span Task
Digit Span is a core working memory sub-test of the WAIS-IV (Wechsler, 2008). It requires participants to repeat a series of digits forwards and backwards with series ranging in length from 2 to 9 digits. This test also measures auditory sequential processing as the individual must recall auditory information and repeat it back aloud. The Digit Span subtest has revealed an average test-retest reliability of .82 (Wechsler, 2008b).
Letter-Number Sequencing Task
Letter Number Sequencing is a subtest of the WAIS-IV (Wechsler, 2008) and is a measure of attention and short-term memory. Lemay et al. (2004) report test-retest reliability data of between .73 and .75 in a two-week interval in middle aged to elderly subjects suggesting it can be reliably used in repeated neuropsychological assessments.
The Cognitive Failures Questionnaire
The Cognitive Failures Questionnaire (Broadbent et al., 1982) will be used as a measure of subjective cognitive complaints. The CFQ has been shown to have acceptable internal consistency and retest reliability, and good face validity in a sample of older adults (Knight et al., 2004).
The Five Facet Mindfulness Questionnaire (FFMQ)
The Five Facet Mindfulness Questionnaire (FFMQ): The FFMQ (Baer et al., 2006) assesses five components of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. It has been shown to have good internal consistency (Baer et al., 2006) and adequate construct validity (Baer et al., 2008).
Ruminative Response Scale of the Response Styles Questionnaire
Ruminative Response Scale of the Response Styles Questionnaire (RRS of RSQ; Nolen-Hoeksema & Morrow, 1991). The RRS will be administered to assess participants' tendencies to ruminate in response to their symptoms of negative emotion. The RRS includes 22 items in response to depressed mood that are self-focused (e.g., "I think why do I always react this way?"), symptom focused (e.g., "I think about how hard it is to concentrate"), and focused on the possible consequences and causes of mood (e.g., "I think I won't be able to do my job if I don't snap out of this"), which participants rate on a scale from 1 (never) to 4 (always). Total scores range from 22 to 88 with higher scores indicating greater rumination.
Self-Compassion Scale Short-Form
Self-Compassion Scale Short-Form (SCS-SF): The SCS-SF (Raes, Pommier, Neff, & Van Gucht, 2011) measures self-compassion and it has the following sub-scales: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Participants have to rate how often they behave in a stated manner (e.g., "When I'm going through a very hard time, I give myself the caring and tenderness I need") in a scale from 1 (almost never) to 5 (almost always). Total scores range from 12 to 60 with higher scores indicating greater self-compassion
CORE-10
CORE-10. The CORE-10 is a short, 10 item version of the CORE-OM, a standard measure of psychological distress
Discharge Satisfaction Questionnaire
The Discharge Satisfaction Questionnaire, (a standard service measure used within the MHOA CAG) will be completed by both the mindfulness and WLC group at post-intervention only to evaluate service satisfaction and the acceptability of the mindfulness intervention

Full Information

First Posted
August 31, 2016
Last Updated
September 12, 2016
Sponsor
King's College London
search

1. Study Identification

Unique Protocol Identification Number
NCT02902692
Brief Title
Mindfulness for Older Adults With Cognitive Concerns
Official Title
Examining the Effects of a Brief Mindfulness Based Intervention (BMBI) on Mood and Cognitive Functioning in an Older Adult Population
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Participants will be randomly assigned to either the BMBI group or the WLC group. Those assigned to the BMBI group will complete a number of cognitive assessments and questionnaires at Time 1. They will then receive a 45 minute mindfulness intervention. Following this, they will be asked to practice mindfulness for 30 minutes per day for 7 days a week in their own homes. After 7 days, participants in the BMBI group will be invited to complete a paired set of cognitive assessments and questionnaires (Time 2). Participants in the WLC group will complete the same number of cognitive assessments and questionnaires as the BMBI group at Time 1. However, they will not receive the 45 minute mindfulness intervention nor will they be asked to practice it at home for 7 days. After 7 days, participants in the WLC group will be invited to complete a paired set of cognitive assessments and questionnaires (Time 2). After completion of the measures at Time 2, the WLC participants will then receive the 45 minute mindfulness intervention. All assessments, questionnaires and the intervention will be carried out either in a SLaM memory clinic or at participants own homes depending on level of mobility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
brief, mindfulness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brief Mindfulness
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Brief Mindfulness
Intervention Description
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.
Primary Outcome Measure Information:
Title
Test of Everyday Attention
Description
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.
Time Frame
Change in attention from Baseline to 1 Week
Secondary Outcome Measure Information:
Title
Hospital Anxiety Depression Scale (HADS)
Description
The HADS consists of two subscales measuring depression and anxiety respectively. Each subscale consists of seven items and responses on the items are based on the relative frequency of symptoms over the past week using a four point Likert scale ranging from 0 (not at all) to 3 (very often indeed). Higher scores indicate higher levels of depression and anxiety, and scores of about 10 on each subscale indicate clinical significance.
Time Frame
Change in anxiety and depression from Baseline to 1 Week
Title
Penn State Worry Questionnaire
Description
Penn State Worry Questionnaire: The PSWQ is a 16-item measure of worry that has shown adequate internal consistency and convergent validity in elderly patients with GAD and controls( Beck et al., 1995 and Stanley et al., 2001). It uses a Likert rating from 1 (not at all typical of me) to 5 (very typical of me).
Time Frame
Change in worry from Baseline to 1 Week
Title
Short Form Health Survey
Description
Short-Form Health Survey (SF-36): The physical and mental summary scores of the Short Form Health Survey (SF-36) (Van de Zee et al., 1993) are used to measure quality of life related to physical and mental aspects. The SF-36 is composed of 36 items measuring health across eight dimensions: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, pain, mental health, vitality, and general health perception. These eight subscales can be summarized into one physical and one mental component summary score. Each dimension score ranges from 0-100. Higher scores indicate better health-related quality of life.
Time Frame
Change in quality of life from Baseline to 1 Week
Title
The Trail Making Test Parts A&B
Description
The Trail Making Test (TMT; Army Individual Test Battery, 1944) is a commonly used neuropsychological test of visual attention and task switching. It consists of 2 parts: part A asks participants to connect a series of numbers in ascending order on a page, while part B requires participants to draw a line alternating between ascending numbers and letters. Part A is used primarily to capture processing speed whereas Part B requires more complex attention shifting, planning, and concentration, and is, thus, considered a valid index of executive control. The time taken to complete the task is the primary performance outcome
Time Frame
Change in executive functioning from Baseline to 1 Week
Title
Digit Span Task
Description
Digit Span is a core working memory sub-test of the WAIS-IV (Wechsler, 2008). It requires participants to repeat a series of digits forwards and backwards with series ranging in length from 2 to 9 digits. This test also measures auditory sequential processing as the individual must recall auditory information and repeat it back aloud. The Digit Span subtest has revealed an average test-retest reliability of .82 (Wechsler, 2008b).
Time Frame
Change in working memory from Baseline to 1 Week
Title
Letter-Number Sequencing Task
Description
Letter Number Sequencing is a subtest of the WAIS-IV (Wechsler, 2008) and is a measure of attention and short-term memory. Lemay et al. (2004) report test-retest reliability data of between .73 and .75 in a two-week interval in middle aged to elderly subjects suggesting it can be reliably used in repeated neuropsychological assessments.
Time Frame
Change in working memory from Baseline to 1 Week
Title
The Cognitive Failures Questionnaire
Description
The Cognitive Failures Questionnaire (Broadbent et al., 1982) will be used as a measure of subjective cognitive complaints. The CFQ has been shown to have acceptable internal consistency and retest reliability, and good face validity in a sample of older adults (Knight et al., 2004).
Time Frame
Change in subjective cognitive concerns from Baseline to 1 Week
Title
The Five Facet Mindfulness Questionnaire (FFMQ)
Description
The Five Facet Mindfulness Questionnaire (FFMQ): The FFMQ (Baer et al., 2006) assesses five components of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. It has been shown to have good internal consistency (Baer et al., 2006) and adequate construct validity (Baer et al., 2008).
Time Frame
Change in mindfulness from Baseline to 1 Week
Title
Ruminative Response Scale of the Response Styles Questionnaire
Description
Ruminative Response Scale of the Response Styles Questionnaire (RRS of RSQ; Nolen-Hoeksema & Morrow, 1991). The RRS will be administered to assess participants' tendencies to ruminate in response to their symptoms of negative emotion. The RRS includes 22 items in response to depressed mood that are self-focused (e.g., "I think why do I always react this way?"), symptom focused (e.g., "I think about how hard it is to concentrate"), and focused on the possible consequences and causes of mood (e.g., "I think I won't be able to do my job if I don't snap out of this"), which participants rate on a scale from 1 (never) to 4 (always). Total scores range from 22 to 88 with higher scores indicating greater rumination.
Time Frame
Change in rumination from Baseline to 1 Week
Title
Self-Compassion Scale Short-Form
Description
Self-Compassion Scale Short-Form (SCS-SF): The SCS-SF (Raes, Pommier, Neff, & Van Gucht, 2011) measures self-compassion and it has the following sub-scales: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Participants have to rate how often they behave in a stated manner (e.g., "When I'm going through a very hard time, I give myself the caring and tenderness I need") in a scale from 1 (almost never) to 5 (almost always). Total scores range from 12 to 60 with higher scores indicating greater self-compassion
Time Frame
Change in self-compassion from Baseline to 1 Week
Title
CORE-10
Description
CORE-10. The CORE-10 is a short, 10 item version of the CORE-OM, a standard measure of psychological distress
Time Frame
Change in general psychological functioning from Baseline to 1 Week
Title
Discharge Satisfaction Questionnaire
Description
The Discharge Satisfaction Questionnaire, (a standard service measure used within the MHOA CAG) will be completed by both the mindfulness and WLC group at post-intervention only to evaluate service satisfaction and the acceptability of the mindfulness intervention
Time Frame
Post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:People aged 50 years and older with subjective memory concerns (SMC) and/or those who meet criteria for amnestic mild cognitive impairment (MCI) who have been seen by one of the three SLAM memory services (i.e. Croydon Memory Service; Southwark and Lambeth Memory Service; and Lewisham Memory Service) in the past three months. Participants must be able to give informed consent to participate. - Exclusion Criteria: Diagnosis of dementia or multi-domain mild cognitive impairment, intellectual disability, current substance misuse, a current diagnosis of epilepsy or another neurodegenerative disorder (such as Parkinson's), a history of brain injury or stroke, a severe and enduring mental health disorder (e.g. severe depression or anxiety, personality disorder, schizophrenia, schizoaffective disorder, bipolar affective disorder), active suicidal ideation, severe sensory impairment that would significantly impair a person's ability to engage in the intervention. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pearlene Ng, BSc
Phone
07562988867
Email
pearlene.ng@kcl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Aisling Roche, BSc,MSc
Phone
07778485687
Email
aisling.roche@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Gould, PhD,DClinPsy
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
South London and Maudsely NHS Memory Services
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Gould, PHD
Phone
02078480346
Email
rebecca.gould@kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
David Matthews, PHD
Phone
02032289500
Email
david.matthews@slam.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mindfulness for Older Adults With Cognitive Concerns

We'll reach out to this number within 24 hrs