Mindfulness for Older Adults With Cognitive Concerns
12. září 2016 aktualizováno: King's College London
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.
Přehled studie
Detailní popis
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.
Typ studie
Intervenční
Zápis (Očekávaný)
90
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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London, Spojené království, SE5 8AF
- Nábor
- South London and Maudsely NHS Memory Services
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Kontakt:
- Rebecca Gould, PHD
- Telefonní číslo: 02078480346
- E-mail: rebecca.gould@kcl.ac.uk
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Kontakt:
- David Matthews, PHD
- Telefonní číslo: 02032289500
- E-mail: david.matthews@slam.nhs.uk
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
50 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
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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Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Brief Mindfulness
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)
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Test of Everyday Attention
Časové okno: Change in attention from Baseline to 1 Week
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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.
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Change in attention from Baseline to 1 Week
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Hospital Anxiety Depression Scale (HADS)
Časové okno: Change in anxiety and depression from Baseline to 1 Week
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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.
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Change in anxiety and depression from Baseline to 1 Week
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Penn State Worry Questionnaire
Časové okno: Change in worry from Baseline to 1 Week
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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).
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Change in worry from Baseline to 1 Week
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Short Form Health Survey
Časové okno: Change in quality of life from Baseline to 1 Week
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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.
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Change in quality of life from Baseline to 1 Week
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The Trail Making Test Parts A&B
Časové okno: Change in executive functioning from Baseline to 1 Week
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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
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Change in executive functioning from Baseline to 1 Week
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Digit Span Task
Časové okno: Change in working memory from Baseline to 1 Week
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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).
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Change in working memory from Baseline to 1 Week
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Letter-Number Sequencing Task
Časové okno: Change in working memory from Baseline to 1 Week
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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.
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Change in working memory from Baseline to 1 Week
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The Cognitive Failures Questionnaire
Časové okno: Change in subjective cognitive concerns from Baseline to 1 Week
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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).
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Change in subjective cognitive concerns from Baseline to 1 Week
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The Five Facet Mindfulness Questionnaire (FFMQ)
Časové okno: Change in mindfulness from Baseline to 1 Week
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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).
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Change in mindfulness from Baseline to 1 Week
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Ruminative Response Scale of the Response Styles Questionnaire
Časové okno: Change in rumination from Baseline to 1 Week
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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.
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Change in rumination from Baseline to 1 Week
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Self-Compassion Scale Short-Form
Časové okno: Change in self-compassion from Baseline to 1 Week
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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
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Change in self-compassion from Baseline to 1 Week
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CORE-10
Časové okno: Change in general psychological functioning from Baseline to 1 Week
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CORE-10.
The CORE-10 is a short, 10 item version of the CORE-OM, a standard measure of psychological distress
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Change in general psychological functioning from Baseline to 1 Week
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Discharge Satisfaction Questionnaire
Časové okno: Post-treatment
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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
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Post-treatment
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Rebecca Gould, PhD,DClinPsy, King's College London
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. dubna 2016
Primární dokončení (Očekávaný)
1. března 2017
Dokončení studie (Očekávaný)
1. května 2017
Termíny zápisu do studia
První předloženo
31. srpna 2016
První předloženo, které splnilo kritéria kontroly kvality
12. září 2016
První zveřejněno (Odhad)
16. září 2016
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
16. září 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
12. září 2016
Naposledy ověřeno
1. dubna 2016
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 16/LO/0223
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