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Mild Cognitive ImpairmentNCT02902692

Mindfulness for Older Adults With Cognitive Concerns

A study testing Brief Mindfulness in people with Mild Cognitive Impairment, run by King's College London at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Brief Mindfulness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited Kingdom
Study dates
Apr 2016to May 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 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

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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.

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Trial locations and contacts

1 site in 1 country.

Pearlene Ng, BSc contact

07562988867

pearlene.ng@kcl.ac.uk

Aisling Roche, BSc,MSc contact

07778485687

aisling.roche@kcl.ac.uk

United Kingdom1 site, 1 recruiting
  • South London and Maudsely NHS Memory Services

    London, London, SE5 8AF

    Rebecca Gould, PHD, 02078480346, rebecca.gould@kcl.ac.uk

    David Matthews, PHD, 02032289500, david.matthews@slam.nhs.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: Examining the Effects of a Brief Mindfulness Based Intervention (BMBI) on Mood and Cognitive Functioning in an Older Adult Population

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.

Read the 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.

Being tested
Brief Mindfulness
Keywords
brief, mindfulness
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief MindfulnessOther

    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.

Study groups in NCT02902692
Study groupRoleWhat they receive
Brief MindfulnessExperimental45 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)
Receives: Other: Brief Mindfulness

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change in attention from Baseline to 1 Week

Secondary outcomes (12)
  1. 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.

    Measured: Change in anxiety and depression from Baseline to 1 Week

  2. 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).

    Measured: Change in worry from Baseline to 1 Week

  3. 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.

    Measured: Change in quality of life from Baseline to 1 Week

  4. 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

    Measured: Change in executive functioning from Baseline to 1 Week

  5. 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).

    Measured: Change in working memory from Baseline to 1 Week

  6. 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.

    Measured: Change in working memory from Baseline to 1 Week

  7. 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).

    Measured: Change in subjective cognitive concerns from Baseline to 1 Week

  8. 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).

    Measured: Change in mindfulness from Baseline to 1 Week

  9. 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.

    Measured: Change in rumination from Baseline to 1 Week

  10. 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

    Measured: Change in self-compassion from Baseline to 1 Week

  11. CORE-10

    CORE-10. The CORE-10 is a short, 10 item version of the CORE-OM, a standard measure of psychological distress

    Measured: Change in general psychological functioning from Baseline to 1 Week

  12. 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

    Measured: Post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionMar 2017 (estimated)
  4. Study completionMay 2017 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02902692
Sponsor's protocol ID
16/LO/0223
Status last verified
Apr 2016
First submitted
31 Aug 2016
Last updated
16 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Brief Mindfulness in people with Mild Cognitive Impairment, run by King's College 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?

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: status not confirmed, as of the sponsor's last update on 16 Sep 2016. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pearlene Ng, BSc (07562988867, pearlene.ng@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Test of Everyday Attention (time frame: Change in attention from Baseline to 1 Week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 16 Sep 2016; AzTrials last refreshed its copy on 2 Nov 2026.

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