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.
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.
-
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.
-
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- 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
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.
- Conditions
- Mild Cognitive Impairment
- 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 group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Brief Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted16 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Gould, PhD,DClinPsy, Principal investigator, King's College London
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of a Brief Mindfulness Based Intervention (BMBI) on Mood and Cognitive Functioning in an Older Adult Population
- ClinicalTrials.gov ID
- NCT02902692
- Acronym / sponsor ID
- 16/LO/0223
- Conditions
- Mild Cognitive Impairment
- Keywords
- brief, mindfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief Mindfulness | Experimental | Other: Brief Mindfulness45 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) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Mindfulness15 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. | Other | Brief Mindfulness |
Primary outcome
Test of Everyday Attention
Time frame: Change in attention from Baseline to 1 Week
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.
12 secondary outcomes
Hospital Anxiety Depression Scale (HADS)
Time frame: Change in anxiety and depression from Baseline to 1 Week
Penn State Worry Questionnaire
Time frame: Change in worry from Baseline to 1 Week
Short Form Health Survey
Time frame: Change in quality of life from Baseline to 1 Week
The Trail Making Test Parts A&B
Time frame: Change in executive functioning from Baseline to 1 Week
Digit Span Task
Time frame: Change in working memory from Baseline to 1 Week
Letter-Number Sequencing Task
Time frame: Change in working memory from Baseline to 1 Week
The Cognitive Failures Questionnaire
Time frame: Change in subjective cognitive concerns from Baseline to 1 Week
The Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Change in mindfulness from Baseline to 1 Week
Ruminative Response Scale of the Response Styles Questionnaire
Time frame: Change in rumination from Baseline to 1 Week
Self-Compassion Scale Short-Form
Time frame: Change in self-compassion from Baseline to 1 Week
CORE-10
Time frame: Change in general psychological functioning from Baseline to 1 Week
Discharge Satisfaction Questionnaire
Time frame: Post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Mild Cognitive Impairment
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Recruiting
Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Parkinson Disease, Mild Cognitive Impairment
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
Recruiting
Combating Alzheimer's Through Sleep and Exercise
Dementia, Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Gould, PhD,DClinPsy principal investigator
King's College London
1 site in 1 country: see every site and its status.
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.