Effects Of An 8-Weeks Mindfulness-based Intervention In Individuals With Subjective Cognitive Decline

NCT03005652 | Completed

• 1 other identifier: C16-61
• Study Type: interventional
• Target: 168
• Locations: 4 countries
• Sites: 4

Brief Summary

The European Commission Horizon 2020 programme has funded the SCD-WELL trial to investigate the efficacy of mindfulness-based training to reduce anxiety in individuals with Subjective Cognitive Decline (SCD), in comparison to an active comparison condition. It is increasingly recognized that most neuropathological processes start years before the onset of clinical Alzheimer's disease (AD). Hence, there is a growing urgency to target individuals in the earliest stages for intervention when neurodegeneration is still limited. Individuals clinically judged to have SCD, defined by subjectively experienced cognitive decline but normal performance on cognitive tests, are at increased risk for future cognitive decline and AD. These individuals with SCD currently have no established treatment options. Symptoms of anxiety have high prevalence in this population, and evidence from recent longitudinal research links anxiety with significantly accelerated cognitive decline in at risk individuals. Effectively reducing anxiety in this population may therefore not only relieve participants from burdensome symptoms, but may also slow cognitive decline and delay or prevent the onset of AD. The investigators chose to study the efficacy of a mindfulness-based intervention to reduce anxiety in this population because this type of intervention has been shown to reduce anxiety in a number of populations, including in older adults. Further, accumulating evidence indicates that intensive mindfulness training effectively down-regulates a number of other adverse psychological and biological risk factors for AD, such as stress, depression, insomnia, feelings of loneliness and social exclusion, and cardiovascular risk factors. These findings are relevant to AD because approximately a third of AD cases worldwide might be attributable to potentially modifiable risk factors. In spite of the increased use of mindfulness-based interventions to treat clinical symptoms, these trials often suffer from the lack of an adequate comparison condition and lack of follow up to know whether initial benefits are maintained.

Conditions

Cognitive Dysfunction

Keywords

Subjective Cognitive Decline; Mental Health; Meditation; Health Education

Outcome Measures

Primary Outcomes (1)

• Mean change in anxiety after the intervention

  (measured by the trait-STAI)

  Between baseline and the end of the 8-week interventions

Secondary Outcomes (8)

• Mean change in anxiety from baseline to 24 weeks

  From baseline and 24 weeks

• Change in depression by the Geriatric Depression Scale (GDS)

  a) from baseline to the end of the 8-week intervention b) from baseline to 24 weeks.

• Change in behavioural measures of compassion measured by the Self Compassion and Compassionate Love Scale questionnaires

  a) from baseline to the end of the 8-week intervention b) from baseline to 24 weeks.

• Change in cognitive function assessed by a composite score derived from neuropsychological tests.

  a) from baseline to the end of the 8-week intervention b) from baseline to 24 weeks.

• Subjective measures of sleep collected via the Pittsburg Sleep Quality Index questionnaire

  a) from baseline to the end of the 8-week intervention b) from baseline to 24 weeks.

Other Outcomes (5)

• Difference in partner perceptions of participant mindfulness measured by Five-Facet Mindfulness Questionnaire (FFMQ-15, range 15-75, higher scores indicate greater mindfulness)

  a) from baseline to the end of the 8-week intervention and b) from baseline to 24 weeks.

• Difference in partner perceptions of participant compassion towards others measured by Compassionate Love Scale (Range 21-147, higher scores indicate greater compassion)

  a) from baseline to the end of the 8-week intervention and b) from baseline to 24 weeks.

• Difference in partner perceptions of participant depression measured by the Geriatric Depression Scale (range 0-15, higher scores indicate greater depressive symptoms)

  a) from baseline to the end of the 8-week intervention and b) from baseline to 24 weeks.

Study Arms (2)

Mindfulness intervention

EXPERIMENTAL

consists of eight weekly group-based sessions of 2 hours duration and an individual pre-class interview, in which the participants will be socialised to the treatment. The intervention will combine intensive training in mindfulness and compassion meditation and gentle yoga practices with psycho-educational components targeted at helping individuals to deal more effectively with emotional difficulties and stressors commonly encountered in old age. These will include addressing concerns about cognitive functioning and health, and will have a particular emphasis on cultivating wholesome attitudes towards self and others.

Behavioral: Mindfulness weekly courses for 8 weeks

Health education intervention

ACTIVE COMPARATOR

follow the same format and structure as the mindfulness-based intervention, and will be matched to the mindfulness-based intervention in administration, dosage, and duration. The treatment is based on a published manual, with every session of the program covering different subjects, including self-management, problem-solving, sleep, stress, exercise, managing medicines and memory, communicating with family, friends, and healthcare professionals, eating, weight management, and planning for the future. Participants will be provided with information about these subjects and engage in group exercises and discussions about these subjects. They will be given a workbook and asked to actively engage in activities described in by the workbook to improve health and well-being on 6 out of 7 days each week, matching home assignments in the mindfulness-based intervention.

Behavioral: Health education weekly courses for 8 weeks

Interventions

Mindfulness weekly courses for 8 weeks BEHAVIORAL

The mindfulness intervention combines intensive training in mindfulness and compassion meditations, light movement and yoga activities, and psycho-educational components to promote nonjudgmental awareness of present moment experiences.

Mindfulness intervention

Health education weekly courses for 8 weeks BEHAVIORAL

The health education intervention is group-based programme has been developed and validated in an SCD population. Each session of the course covers different subjects, which include self-management, problem-solving, sleep, stress, exercise, managing medicines and memory, communicating with healthcare professionals, eating, and planning for the future.

Health education intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 60 years
• Meet the research criteria proposed by the international SCD-I working group for studies in SCD
• Performance within the normal range on standardised cognitive tests according to agreed study-specific standards to rule out mild cognitive impairment (MCI) and dementia
• Either referred to the memory clinic by a physician or who are self-referrals because of memory concerns (assessed by a positive response to the question 'Are you worried about your memory?')
• Ability to provide informed consent in accordance with International Conference on Harmonization of Good Clinical Practice (GCP/ICH) guidelines and local regulations
• State that they are available for the trial duration

You may not qualify if:

• Presence of a major neurological or psychiatric disorder (including generalised anxiety, major depressive disorder, or an addiction to alcohol or drugs) according to ICD-10 and/or DSM 5 criteria
• Under legal guardianship or incapacitation
• History of cerebral disease (vascular, degenerative, physical malformation, tumor, or head trauma with loss of consciousness for more than an hour) which interferes with the aims of the study protocol
• Presence of a chronic disease or acute unstable illness (respiratory, cardiovascular, digestive, renal, metabolic, hematologic, endocrine or infectious) which interferes with the aims of the study protocol
• Current or recent medication that may interfere with cognitive action (psychotropic, systemic corticosteroid, anti-Parkinson's, or analgesic drugs). The interfering nature of the different treatments will be at the discretion of the investigating doctor.
• Have regularly or intensively practiced meditation or comparable practices (yoga, Qi Gong, Alexander technique)
• more than one day per week for more than six months consecutively over the last 10 years,
• intensively (internship or retreat \> five consecutive days) over the past 10 years,
• more than 25 days of retreats (cumulatively) prior to the last 10 years.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (4)

The Clinical Research Memory Centre of Lyon (CMRR), department of the University Hospitals of Lyon - Hospices Civils de Lyon (HCL)

Lyon, France

Location

The Department of Psychiatry at University of Cologne (UKK)

Cologne, Germany

Location

The Consorci Institut D'Investigacions Biomediques August Pi i Sunyer (IDIBAPS)

Barcelona, Spain

Location

The Division of Psychiatry at University College London (UCL).

London, England, United Kingdom

Location

Related Publications (7)

• Masebo L, Whitfield T, Demnitz-King H, Heslegrave A, Poisnel G, Lutz A, Frison E, Wirth M, Hye A, Jessen F, Ashton NJ, Zetterberg H, Marchant NL. Can non-pharmacological interventions change levels of neurofilament light in older adults at risk of dementia? A secondary analysis of the SCD-Well randomized clinical trial. J Prev Alzheimers Dis. 2025 Sep;12(8):100299. doi: 10.1016/j.tjpad.2025.100299. Epub 2025 Jul 18.

  PMID: 40683836 RESULT

• D'elia Y, Whitfield T, Schlosser M, Lutz A, Barnhofer T, Chetelat G, Marchant NL, Gonneaud J, Klimecki O; Medit-Ageing group. Impact of mindfulness-based and health self-management interventions on mindfulness, self-compassion, and physical activity in older adults with subjective cognitive decline: A secondary analysis of the SCD-Well randomized controlled trial. Alzheimers Dement (Amst). 2024 Mar 4;16(1):e12558. doi: 10.1002/dad2.12558. eCollection 2024 Jan-Mar.

  PMID: 38440222 RESULT

• Marchant NL, Barnhofer T, Klimecki OM, Poisnel G, Lutz A, Arenaza-Urquijo E, Collette F, Wirth M, Schild AK, Coll-Padros N, Reyrolle L, Horney D, Krolak-Salmon P, Molinuevo JL, Walker Z, Maillard A, Frison E, Jessen F, Chetelat G; SCD-WELL Medit-Ageing Research Group. The SCD-Well randomized controlled trial: Effects of a mindfulness-based intervention versus health education on mental health in patients with subjective cognitive decline (SCD). Alzheimers Dement (N Y). 2018 Dec 14;4:737-745. doi: 10.1016/j.trci.2018.10.010. eCollection 2018.

  PMID: 30581979 RESULT

• Marchant NL, Barnhofer T, Coueron R, Wirth M, Lutz A, Arenaza-Urquijo EM, Collette F, Poisnel G, Demnitz-King H, Schild AK, Coll-Padros N, Delphin-Combe F, Whitfield T, Schlosser M, Gonneaud J, Asselineau J, Walker Z, Krolak-Salmon P, Molinuevo JL, Frison E, Chetelat G, Jessen F, Klimecki OM; The Medit-Ageing Research Group. Effects of a Mindfulness-Based Intervention versus Health Self-Management on Subclinical Anxiety in Older Adults with Subjective Cognitive Decline: The SCD-Well Randomized Superiority Trial. Psychother Psychosom. 2021;90(5):341-350. doi: 10.1159/000515669. Epub 2021 Apr 19.

  PMID: 33873195 RESULT

• Whitfield T, Demnitz-King H, Schlosser M, Barnhofer T, Frison E, Coll-Padros N, Dautricourt S, Requier F, Delarue M, Gonneaud J, Klimecki OM, Lutz A, Paly L, Salmon E, Schild AK, Walker Z, Jessen F, Chetelat G, Collette F, Wirth M, Marchant NL; Medit-Ageing Research Group. Effects of a mindfulness-based versus a health self-management intervention on objective cognitive performance in older adults with subjective cognitive decline (SCD): a secondary analysis of the SCD-Well randomized controlled trial. Alzheimers Res Ther. 2022 Sep 6;14(1):125. doi: 10.1186/s13195-022-01057-w.

  PMID: 36068621 RESULT

• Schlosser M, Demnitz-King H, Barnhofer T, Collette F, Gonneaud J, Chetelat G, Jessen F, Kliegel M, Klimecki OM, Lutz A, Marchant NL; Medit-Ageing Research Group. Effects of a mindfulness-based intervention and a health self-management programme on psychological well-being in older adults with subjective cognitive decline: Secondary analyses from the SCD-Well randomised clinical trial. PLoS One. 2023 Dec 15;18(12):e0295175. doi: 10.1371/journal.pone.0295175. eCollection 2023.

  PMID: 38100477 RESULT

• Demnitz-King H, Gonneaud J, Klimecki OM, Chocat A, Collette F, Dautricourt S, Jessen F, Krolak-Salmon P, Lutz A, Morse RM, Molinuevo JL, Poisnel G, Touron E, Wirth M, Walker Z, Chetelat G, Marchant NL; Medit-Ageing Research Group. Association of Self-reflection With Cognition and Brain Health in Cognitively Unimpaired Older Adults. Neurology. 2022 Sep 27;99(13):e1422-e1431. doi: 10.1212/WNL.0000000000200951. Epub 2022 Jul 19.

  PMID: 35853750 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction; Psychological Well-Being; Health Education

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Personal Satisfaction; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Frank Jessen

  Director of the Clinic for Psychiatry and Psychotherapy at University Hospital Cologne

  PRINCIPAL INVESTIGATOR

• Natalie Marchant

  Division of Psychiatry, University College London

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The trial will compare outcomes in two groups of participants randomised to one of two study arms, either receiving: (i) an 8-week mindfulness-based intervention, using a secular form of mindfulness training; or (ii) an 8-week validated health-educational programme (comparison condition, see section 6.3 for description) The randomization will be performed with a 1:1 allocation. The primary outcome will be change in symptoms of anxiety from baseline to 8 weeks.

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 29, 2016
• Study Start: April 21, 2017
• Primary Completion: September 18, 2018
• Study Completion: September 18, 2018
• Last Updated: December 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); FR (1); DE (1); GB (1)