Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03195985 |
| Other study ID # |
C&W1234 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
December 2, 2016 |
| Last updated |
March 12, 2018 |
| Start date |
July 1, 2017 |
| Est. completion date |
February 1, 2018 |
Study information
| Verified date |
March 2018 |
| Source |
Chelsea and Westminster NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study will focus on measuring stress, rumination and cognitive function across three time
points in old adults with subjective cognitive complaints via a 4-week short mindfulness
intervention, as compare to an active control condition (psycho-education course "ge Well").
This is a pilot study.
Description:
20 old adults with subjective cognitive complaints will be recruited from adult day centres
and the Chelsea Westminster Hospital in London. All patients will be aged 65 and above. Each
participant will be randomly allocated to either a mindfulness intervention or the active
control condition (psychoeducation) with 10 participants in each intervention.
A short mindfulness intervention of 4 weeks will be delivered by a trained mindfulness
teacher across four 2 hour sessions that focus on the breath, links between mind and body,
sensory and metacognitive awareness, emotion regulation, movement and compassion using
visually engaging materials that will enhance understanding, encoding and recollection.
There will be one session per week. The proposed study will evaluate the effects of a short
mindfulness intervention in old adults with subjective cognitive complaints. Management of
emotional difficulties associated with anxiety and stress can improve psychological
well-being in sufferers, and in turn can enhance cognitive capacity to maximise function.
Mindfulness interventions are gentle, non-invasive and cost effective techniques that have
been designed for stress reduction, that have been associated with improvements in mood,
stress, pain management and overall well-being in a range of clinical and healthy
populations. In addition mindfulness interventions have also been shown to improve cognitive
function and emotion regulation by enhancing attentional awareness, attentional flexibility
and attentional capacity. However, very few studies to date focus on elderly participants and
no study to date has tried to shorten the current 8-week Mindfulness-Based Stress Reduction
training in older adult populations.
The psycho-education course will also take 4 consecutive weeks, with one session each week.
All participants will be screened (see Appendix 6 of protocol) prior to the beginning of the
study and recruited if they fulfil the criteria required as highlighted within the
'participants' section. The screening session will take approximately 20minutes. Written
informed consent will be obtained from the participant prior to performing any study related
evaluations or procedures. Informed consent (see Appendix 4 of protocol) will be taken during
all assessment sessions and also during the screening assessment.
Participants will be provided with written information about the study in the form of a
participant information sheet (see Appendix 3 of protocol) and mindfulness course leaflet,
and will be allowed a minimum of 24 hours for questions and to consider the study before
agreeing to participate. It will be the responsibility of the investigator or co-investigator
to obtain written informed consent prior to undertaking any questionnaires, tests, or hair
sampling detailed within the protocol.
The Mini-Mental State Examination and the National Adult Reading Task will be performed
during a screening session only. All other assessments (cognitive, psychological and
physiological) will be done at baseline, pre- intervention (week 4), and at a follow-up (week
8).
All assessments done during baseline, week 4, and week 8 assessment sessions will take
approximately 45minutes per session. Each assessment session will follow the same order in
which questionnaires and tasks are presented to participant (see Appendix 5 of protocol).
Physiological assessment: Hair cortisol will be sampled from each participant during the
three assessment stages (baseline, week 4, and 8) by obtaining hair samples from
participant's vertex posterior. Each sample will be approximately 0.5cm in diameter, and will
be used for analysis carried out by Stratech (formerly Salimetrics) whereby 10% of the sample
will be extracted in duplicate and the remaining 90% of extractions will be performed in
singlet. Individually wrapped hair samples will be stored at a temperature between 20 and 25
degrees Celsius in a breathable container. The sampling should take approximately 5 minutes
for each participant.
The following hair sampling equipment is not included by Stratech and will need to be
provided by the researcher: thread for tying hair samples, sharp scissors, hair clips, a
pin-tailed comb, aluminium foil, large paper envelopes for long-term storage, and jiffy bags
for shipping.
Cognitive Assessment: The cognitive domain will be assessed based on the Trail Making Task
(TMT) at three time points (baseline, week 4, and 8) and will provide information on
executive function, and also based on the Verbal Fluency Tasks to assess verbal fluency and
executive function. The Everyday Memory Questionnaire (EMQ) will be used to assess subjective
memory function at the three time points (baseline, week 4, and 8). The Verbal Fluency Tasks
will consist of the FAS phonemic fluency task and the Animal Naming Task (semantic fluency).
Psychological Assessment: The psychological domain will be assessed based on the Perceived
Stress Scale (PSS) which will provide information on the subjective stress levels of
participants, and also based on the Penn State Worry Questionnaire - Abbreviated (PSWQ-A)
which will provide information on the amount of worry each participant feels, and also the
Rumination Response Scale (RRS) which will provide information regarding the effect of
mindful exercises on ruminative behaviours. These will all be assessed at the three
assessment points (baseline, week 4, and 8).
Please note all questionnaires and tasks involved are validated.
All questionnaires and tasks will be administered in paper form in the presence of a member
of the research team trained at administering the tasks.
The Mindfulness course:
A short mindfulness course will be delivered by a trained mindfulness teacher and Clinical
Psychologist across four 2-hour sessions.
The course will be accompanied by a booklet designed by Edginton and Nenadlova (in prep)
highlighting the main themes within each session using visually engaging pictures to help
enhance understanding, encoding and recollection (see appendix 1 of protocol).
There will be one session per week for 4 consecutive weeks, at the same time each week. The
details of each session are described below:
Week 1:
Introduction to the topic. Guided mindful eating. Focus on being 'in the moment' and
appreciating the task the participant doing at each point in time.
Mindful eating will take form via eating a raisin - studying the raisin in detail (colour,
sensations such as smell and texture) and focusing in detail on the process involved in
eating the raisin.
The aim of this session will be to teach participants to focus on each task that they are
doing in detail, with the goal to be able to give full attention to each task, without
thinking about the next task.
Homework given in the form of a practice exercise.
Week 2:
Recap of the previous week's topic. Guided mindful breathing exercise, focus on the breath
and being 'in the moment'.
Guided mindful body-scan. Focus on different parts of the body and its sensations via a
guided body scan exercise.
Emphasis on observing sensations rather than judging sensations. Focus on being 'in the
moment', focusing at one thing at a time, and also training the ability to focus attention
and awareness to different parts of the body at will.
Homework given in the form of a practice exercise.
Week 3:
Recap of the previous week's topic. Guided session mindful coping and dealing with
difficulties. The aim of the session will be to become mindfully aware of whatever is most
predominant in the participant's moment by moment experience, and for participants to uncover
how they are relating to feelings and thoughts are arising, and approach them in an accepting
way.
Exercise practiced during the session: The Three Step Breathing Space - creating an imaginary
space around ourselves by imaging our breath expanding beyond our body into the space around
us.
Homework given in the form of a practice exercise.
Week 4:
Recap of the previous week's topic. Guided session on mindful choices and looking after own
self. Exercises involve (a) focusing on what the participant finds nourishing and depleting
in their daily activities and (b) a guided Mountain exercise whereby participants imagine
themselves as being a mountain which stands tall despite the ever-changing environment around
them. Recap of topics covered will be included at the end, and suggestion for how to continue
the practice beyond the course will be provided.
The delivery of the mindfulness intervention will be designed for independent groups of up to
10 participants within one class.
The active control condition:
The active control condition will be identical in length to the mindfulness course. It will
consist of 4 "Age Well" psycho-education sessions. These sessions will aim to provide
individuals with knowledge about general well-being such as healthy movement and activity,
healthy eating, and the importance of cognitive stimulation.
These sessions will run in parallel to the mindfulness course, and will be run by the
Clinical Psychologist.
Participants will be asked to write their name onto an attendance sheet during both
Mindfulness and "Age Well" sessions to track participant attendance throughout the courses
(Appendix 2 of protocol).
Please note that the screening and assessment visits may take place within +/- 7 days based
on the discretion of the Chief Investigator. Date of each assessment visit will be recorded
on the informed consent form which will be signed at each assessment visit.
The research is being funded by the Imperial College Alzheimer's Network, London.
