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Mindfulness training in older patients with cognitive complaints [Dutch: Mindfulnesstraining voor oudere patiŽnten met geheugenklachten]

- candidate number19342
- NTR NumberNTR4749
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-aug-2014
- Secondary IDsMETC 142043.3/ab NL49941.068.14 CCMO
- Public TitleMindfulness training in older patients with cognitive complaints [Dutch: Mindfulnesstraining voor oudere patiŽnten met geheugenklachten]
- Scientific TitlePilot study into the feasibility and effects of Mindfulness-based Stress Reduction (MBSR) in older patients with cognitive complaints
- hypothesisDelivery of a generic MBSR training to patients who visit a memory clinic with cognitive complaints, and who show no clinical signs of a cognitive disorder, is feasible.
- Healt Condition(s) or Problem(s) studiedMild Cognitive Impairment (MCI)
- Inclusion criteria- Age between 50 and 75 years
- Existing complaints about at least one, or more aspects of cognitive functioning
- Expressed personal interest in participation in the training program
- Patients receive no further treatment for their complaint and will not revisit the memory clinic for a follow-up assessment for a period of at least 6 months
- Able to communicate in the Dutch language
- Availability on at least 7 of 8 (fixed) session dates
- Agreement to participate in homework assignments
- Home access to PC with internet connection (cognitive tests)
- Signed informed consent
- Exclusion criteria- Clinical evidence of psychiatric comorbidity, or any psychotropic drug usage on a daily basis, which could interfere with participation in the group sessions and homework assignments
- Patients who receive (or will receive in a period of 4 months) medical treatment or psychological intervention of any kind for their cognitive condition
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-okt-2014
- planned closingdate31-mrt-2015
- Target number of participants12
- InterventionsCustom 8-week Mindfulness-based Stress Reduction (MBSR)
- Primary outcomeFeasibility of delivering a generic MBSR training to patients who visit a memory clinic with cognitive complaints, and who show no clinical signs of a cognitive disorder
- Secondary outcome- To determine the bottlenecks in the delivery of MBSR training in combination with empirical research in this target population
- To determine preliminary evidence of health and cognition related indicators that may be sensitive to the MBSR training
- TimepointsWeek 0: interview, screening and assessment
Week 1-8: training
Week 9:assessment and interview
Week 13: 4-week follow-up assessment
- Trial web site
- statusstopped: trial finished
- CONTACT for SCIENTIFIC QUERIESDr. Martin Boxtel, van
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- PublicationsBoxtel, M. P. J., & Speckens, A. (2014). Mindfulness, cognitieve functies en ďsuccesvol ouder worden.Ē Tijdschrift Voor Gerontologie en Geriatrie, 45, 137Ė143. doi:10.1007/s12439-013-0055-z
- Brief summaryRationale: Cognitive complaints of older individuals are often related to worries and concerns related to the ageing process and the associated change in cognitive functioning. Mindfulness-based interventions have been applied successfully to different clinical and non-clinical populations to relieve the burden of stress and ruminative thinking and to improve coping strategies in the context of physical and mental disease.
Objective: Is Mindfulness-based Stress Reduction (MBSR) feasible and effective in older persons with mild cognitive complaints?
Study design: Observational pilot study
Study population: N=10-12 patients of the Maastricht Memory Clinic in the age between 50 and 75 years; no diagnosis of cognitive disorder; no significant psychiatric comorbidity
Intervention (if applicable): Standard 8-week program of MBSR, comprising of 8 weekly group meetings of 2,5h and one silent retreat of 6h. Main study parameters/endpoints: In this feasibility study, participants are interviewed after 8 weeks about their experiences during the training and how the training may be adjusted to fit the requirements for this target population even more in the future. Furthermore, the group effects of the training are evaluated by means of short questionnaires measuring life quality, mental health (perceived stress, anxiety and depressive symptoms), levels of mindfulness and self-compassion, and perceived burden of cognitive complaints, administered at baseline, 9 and 13 weeks. Feasibility of online cognitive assessment is tested at baseline and 9 weeks.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: MBSR training is nowadays widely available and can be safely followed without prior medical screening. Expectation of personal benefit from the training is realistic when the program is followed conscientiously, but cannot be guaranteed beforehand. Apart from the personal effort invested in participation and homework assignments, no adverse effects are to be expected.
- Main changes (audit trail)
- RECORD24-aug-2014 - 22-mei-2016

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