A 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 (SCD-WELL)
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|ClinicalTrials.gov Identifier: NCT03005652|
Recruitment Status : Active, not recruiting
First Posted : December 29, 2016
Last Update Posted : July 10, 2018
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Dysfunction||Behavioral: Mindfulness weekly courses for 8 weeks Behavioral: Health education weekly courses for 8 weeks||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Outcomes Assessor)|
|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|
|Actual Study Start Date :||April 21, 2017|
|Estimated Primary Completion Date :||March 1, 2019|
|Estimated Study Completion Date :||January 31, 2020|
|Experimental: Mindfulness intervention||
Behavioral: Mindfulness weekly courses for 8 weeks
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.
|Active Comparator: Health education intervention||
Behavioral: Health education weekly courses for 8 weeks
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.
- Mean change in anxiety after the intervention [ Time Frame: Between baseline and the end of the 8-week interventions ](measured by the trait-STAI)
- Mean change in anxiety at 16 weeks post-intervention [ Time Frame: Between baseline and 16 weeks post-intervention follow-up ]measured by the state-STAI
- Change in cognition assessed by neuropsychological tests [ Time Frame: Between baseline and the end of the 8-week intervention ; Between baseline and 16 weeks post-intervention follow-up ]One composite score per cognitive area assessed by the neuropsychological tests. For each score within a cognitive area, a z score is computed for each participant [(participant score - mean)/standard deviation]. Then the composite variable for that cognitive area is created by summing up z scores. Additional exploratory analyses will be conducted on all individual behavioural measures obtained. These cognitive tests include: Mattis Dementia Rating Scale (DRS), Stroop, WAIS IV Coding, Trail Making Test A and B, California Verbal Learning Test (CVLT II), Visual Object Separation Task, phonemic and semantic fluency.
- Change in compassion assessed by questionnaires [ Time Frame: Between baseline and the end of the 8-week intervention ; Between baseline and 16 weeks post-intervention follow-up ]Self-compassion questionnaire, compassion towards others questionnaire.
- Change in sleep quality assessed by questionnaires [ Time Frame: Between baseline and the end of the 8-week intervention ; Between baseline and 16 weeks post-intervention follow-up ]Pittsburgh Sleep Quality Index (PSQI)
- Change in physical activity assessed by questionnaires [ Time Frame: Between baseline and the end of the 8-week intervention ; Between baseline and 16 weeks post-intervention follow-up ]The Physical Activity Scale for the Elderly (PASE)
- Change in wellbeing and quality of life assessed by questionnaires [ Time Frame: Between baseline and the end of the 8-week intervention ; Between baseline and 16 weeks post-intervention follow-up ]Measures include The World Health Organization Quality of Life short version (WHOQOL-bref), Ryff's psychological well-being questionnaire and the three-item loneliness scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03005652
|The Clinical Research Memory Centre of Lyon (CMRR), department of the University Hospitals of Lyon - Hospices Civils de Lyon (HCL)|
|The Department of Psychiatry at University of Cologne (UKK)|
|The Consorci Institut D'Investigacions Biomediques August Pi i Sunyer (IDIBAPS)|
|The Division of Psychiatry at University College London (UCL).|
|London, England, United Kingdom|
|Principal Investigator:||Frank Jessen||Director of the Clinic for Psychiatry and Psychotherapy at University Hospital Cologne|