Cognitive DysfunctionSCD-WELLNCT03005652
Effects Of An 8-Weeks Mindfulness-based Intervention In Individuals With Subjective Cognitive Decline
A study testing Mindfulness weekly courses for 8 weeks and Health education weekly courses for 8 weeks in people with Cognitive Dysfunction, run by Institut National de la Santé Et de la Recherche Médicale, France at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- Mindfulness weekly courses for 8 weeks and Health education weekly courses for 8 weeks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 21 Apr 2017to 18 Sep 2018
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
France1 site
The Clinical Research Memory Centre of Lyon (CMRR), department of the University Hospitals of Lyon - Hospices Civils de Lyon (HCL)
Lyon
Germany1 site
The Department of Psychiatry at University of Cologne (UKK)
Cologne
Spain1 site
The Consorci Institut D'Investigacions Biomediques August Pi i Sunyer (IDIBAPS)
Barcelona
United Kingdom1 site
The Division of Psychiatry at University College London (UCL).
London, England
About this study
Official title: A Multicenter Randomized Superiority Study To Compare The Effects Of An 8-Weeks Mindfulness-based Intervention Versus Health Education Programme On Mental Health And Wellbeing In Individuals With Subjective Cognitive Decline
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.
Read the detailed description
SCD-WELL includes both an active comparison condition and a 16-week follow up assessment after the end of the intervention. SCD-WELL is a non-CTIMP European multicentre, observer-blinded, randomized, controlled, superiority trial with two parallel groups, which compares anxiety and additional behavioural and biological outcomes amongst people with SCD who receive mindfulness-based training and those who receive a health education comparison intervention. Outcomes will be measured at baseline, post-intervention and 16 weeks after the end of the intervention.
160 older-adult patients diagnosed with SCD will be recruited to the study from memory clinics at four sites in Europe: London, UK; Cologne, Germany; Barcelona, Spain; Lyon, France where they will have sought help due to concern about their memory. Participants will be recruited in two waves over a maximum two-year period and will be provided with a participant information sheet, and asked to consider their participation. Should they wish to participate, and after a signed and dated Informed Consent Form has been obtained, a unique participant identification (ID) will be assigned to the participant.
Behavioural assessments will take place at baseline, after the intervention, and 16 weeks after the end of the intervention. Because we believe that mindfulness-based training has the potential to affect a number of areas of life we will also look at changes in other areas of psycho-affective symptoms, social functioning, awareness, well being and quality of life, sleep quality, and cognition, after the intervention and 16 weeks after the end of the intervention. Validated neuropsychological tests and behavioural questionnaires were selected for their sensitivity to the domains listed above. These measures will be completed alone by the participant or in the presence of a psychometrist. Questionnaires will also be completed by partners at the three time points to coincide with assessments of participants.
Blood samples will be taken at the memory clinic by certified phlebotomists at baseline, after the intervention and during follow-up to measure genetic markers of risk for AD as well as proteomic markers of stress and AD that may be affected by this intervention. Information will also be collected about the medical care of the participant.
Trained facilitators will deliver both interventions. Both interventions follow a manual, are group-based, include at-home activities, and are 8 weeks in duration. Both interventions provide individuals with sustainable skills that remain beyond the intervention period.
- Conditions
- Cognitive Dysfunction
- Being tested
- Mindfulness weekly courses for 8 weeks, Health education weekly courses for 8 weeks
- Keywords
- Subjective Cognitive Decline, Mental Health, Meditation, Health Education
- Medical subject headings
- Cognitive Dysfunction, Psychological Well-Being, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness weekly courses for 8 weeksBehavioural
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.
Health education weekly courses for 8 weeksBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Health education weekly courses for 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in anxiety after the intervention
(measured by the trait-STAI)
Measured: Between baseline and the end of the 8-week interventions
Secondary outcomes (8)
Mean change in anxiety from baseline to 24 weeks
measured by the trait-STAI
Measured: From baseline and 24 weeks
Change in depression by the Geriatric Depression Scale (GDS)
depression (Geriatric Depression Scale) : Range 0-15, higher scores indicate greater depressive symptoms.
Measured: 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
Self Compassion: Range 12-60, higher scores indicate greater compassion. Compassionate Love Scale: Range 21-147, higher scores indicate greater compassion.
Measured: 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.
The composite score will correspond to the mean of z-scores calculated from relevant test scores from the Mattis Dementia Rating Scale-2 (DRS-2), Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding, Rey Auditory Verbal Learning Test (RAVLT), Category Fluency (Animals). Higher z-scores correspond to better cognitive performance.
Measured: 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
collected via the Pittsburg Sleep Quality Index questionnaire: Range 0-21, higher scores indicate better sleep quality
Measured: a) from baseline to the end of the 8-week intervention b) from baseline to 24 weeks.
Change in lifestyle as assessed by The Physical Activity Scale for the Elderly questionnaire
assessed by The Physical Activity Scale for the Elderly questionnaire: Range 0-873, higher scores indicate more physical activity
Measured: a) from baseline to the end of the 8-week intervention b) from baseline to 24 weeks.
Change in quality of life assessed by the world health organization quality of life - brief questionnaire
WHOQOL-bref: Range 21-147, higher scores indicate better quality of life.
Measured: a) from baseline to the end of the 8-week intervention b) from baseline to 24 weeks.
Mean change in blood-based biological markers of stress and Alzheimer's disease assessed by DNA methylation patterns and quantities of proteins - neurofilament light and tau
assessed by DNA methylation patterns and quantities of proteins - neurofilament light and tau
Measured: a) from baseline to the end of the 8-week interventions and b) from baseline to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start21 Apr 2017
- Primary completion18 Sep 2018
- Study completion18 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Frank Jessen, Principal investigator, Director of the Clinic for Psychiatry and Psychotherapy at University Hospital CologneNatalie Marchant, Study director, Division of Psychiatry, University College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005652
- Sponsor's protocol ID
- C16-61
- Acronym
- SCD-WELL
- Status last verified
- Feb 2025
- First submitted
- 16 Dec 2016
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40683836D'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.
PubMed 38440222Marchant 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.
PubMed 30581979Marchant 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.
PubMed 33873195Whitfield 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.
PubMed 36068621Schlosser 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.
PubMed 38100477Demnitz-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.
PubMed 35853750
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Superiority Study To Compare The Effects Of An 8-Weeks Mindfulness-based Intervention Versus Health Education Programme On Mental Health And Wellbeing In Individuals With Subjective Cognitive Decline
- ClinicalTrials.gov ID
- NCT03005652
- Acronym / sponsor ID
- SCD-WELL / C16-61
- Conditions
- Cognitive Dysfunction
- Keywords
- Subjective Cognitive Decline, Mental Health, Meditation, Health Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 18 Sep 2018 (actual)
- Study completion
- 18 Sep 2018 (actual)
- First posted
- 29 Dec 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 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.
Detailed description
SCD-WELL includes both an active comparison condition and a 16-week follow up assessment after the end of the intervention. SCD-WELL is a non-CTIMP European multicentre, observer-blinded, randomized, controlled, superiority trial with two parallel groups, which compares anxiety and additional behavioural and biological outcomes amongst people with SCD who receive mindfulness-based training and those who receive a health education comparison intervention. Outcomes will be measured at baseline, post-intervention and 16 weeks after the end of the intervention.
160 older-adult patients diagnosed with SCD will be recruited to the study from memory clinics at four sites in Europe: London, UK; Cologne, Germany; Barcelona, Spain; Lyon, France where they will have sought help due to concern about their memory. Participants will be recruited in two waves over a maximum two-year period and will be provided with a participant information sheet, and asked to consider their participation. Should they wish to participate, and after a signed and dated Informed Consent Form has been obtained, a unique participant identification (ID) will be assigned to the participant.
Behavioural assessments will take place at baseline, after the intervention, and 16 weeks after the end of the intervention. Because we believe that mindfulness-based training has the potential to affect a number of areas of life we will also look at changes in other areas of psycho-affective symptoms, social functioning, awareness, well being and quality of life, sleep quality, and cognition, after the intervention and 16 weeks after the end of the intervention. Validated neuropsychological tests and behavioural questionnaires were selected for their sensitivity to the domains listed above. These measures will be completed alone by the participant or in the presence of a psychometrist. Questionnaires will also be completed by partners at the three time points to coincide with assessments of participants.
Blood samples will be taken at the memory clinic by certified phlebotomists at baseline, after the intervention and during follow-up to measure genetic markers of risk for AD as well as proteomic markers of stress and AD that may be affected by this intervention. Information will also be collected about the medical care of the participant.
Trained facilitators will deliver both interventions. Both interventions follow a manual, are group-based, include at-home activities, and are 8 weeks in duration. Both interventions provide individuals with sustainable skills that remain beyond the intervention period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness intervention | Experimental | Behavioral: Mindfulness weekly courses for 8 weeksconsists 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. |
| Health education intervention | Active comparator | Behavioral: Health education weekly courses for 8 weeksfollow 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Mindfulness weekly courses for 8 weeksThe 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. | Behavioural | Mindfulness intervention |
| Health education weekly courses for 8 weeksThe 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. | Behavioural | Health education intervention |
Primary outcome
Mean change in anxiety after the intervention
Time frame: Between baseline and the end of the 8-week interventions
(measured by the trait-STAI)
8 secondary outcomes
Mean change in anxiety from baseline to 24 weeks
Time frame: From baseline and 24 weeks
Change in depression by the Geriatric Depression Scale (GDS)
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: a) from baseline to the end of the 8-week intervention b) from baseline to 24 weeks.
Change in lifestyle as assessed by The Physical Activity Scale for the Elderly questionnaire
Time frame: a) from baseline to the end of the 8-week intervention b) from baseline to 24 weeks.
Change in quality of life assessed by the world health organization quality of life - brief questionnaire
Time frame: a) from baseline to the end of the 8-week intervention b) from baseline to 24 weeks.
Mean change in blood-based biological markers of stress and Alzheimer's disease assessed by DNA methylation patterns and quantities of proteins - neurofilament light and tau
Time frame: a) from baseline to the end of the 8-week interventions and b) from baseline to 24 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 40683836Masebo 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.
- Results publication: PubMed 38440222D'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.
- Results publication: PubMed 30581979Marchant 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.
- Results publication: PubMed 33873195Marchant 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.
- Results publication: PubMed 36068621Whitfield 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.
- Results publication: PubMed 38100477Schlosser 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.
- Results publication: PubMed 35853750Demnitz-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.
- Individual participant dataSharing planned: No
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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.
Frank Jessen principal investigator
Director of the Clinic for Psychiatry and Psychotherapy at University Hospital Cologne
Natalie Marchant study director
Division of Psychiatry, University College London
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness weekly courses for 8 weeks and Health education weekly courses for 8 weeks in people with Cognitive Dysfunction, run by Institut National de la Santé Et de la Recherche Médicale, France at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. 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: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, Spain, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in anxiety after the intervention (time frame: Between baseline and the end of the 8-week interventions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03005652, which also lists 7 linked publications.
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 4 Dec 2025.