Clinical trial NCT02902692: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: brief
mindfulness
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

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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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Primary outcomes:
measure: Test of Everyday Attention
timeFrame: Change in attention from Baseline to 1 Week
Secondary outcomes:
measure: Hospital Anxiety Depression Scale (HADS)
timeFrame: Change in anxiety and depression from Baseline to 1 Week
measure: Penn State Worry Questionnaire
timeFrame: Change in worry from Baseline to 1 Week
measure: Short Form Health Survey
timeFrame: Change in quality of life from Baseline to 1 Week
measure: The Trail Making Test Parts A&B
timeFrame: Change in executive functioning from Baseline to 1 Week
measure: Digit Span Task
timeFrame: Change in working memory from Baseline to 1 Week
measure: Letter-Number Sequencing Task
timeFrame: Change in working memory from Baseline to 1 Week
measure: The Cognitive Failures Questionnaire
timeFrame: Change in subjective cognitive concerns from Baseline to 1 Week
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Change in mindfulness from Baseline to 1 Week
measure: Ruminative Response Scale of the Response Styles Questionnaire
timeFrame: Change in rumination from Baseline to 1 Week
measure: Self-Compassion Scale Short-Form
timeFrame: Change in self-compassion from Baseline to 1 Week
measure: CORE-10
timeFrame: Change in general psychological functioning from Baseline to 1 Week
measure: Discharge Satisfaction Questionnaire
timeFrame: Post-treatment
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: South London and Maudsely NHS Memory Services
Study officials:
affiliation: King's College London
name: Rebecca Gould, PhD,DClinPsy
role: PRINCIPAL_INVESTIGATOR
References: