DementiaNCT06451978
You, Me and Nature Pilot Study
A study testing Nature-based intervention in people with Dementia and Mild Cognitive Impairment, run by Harmony Jiang at 1 site in United Kingdom.
Trial summary
Background: Nature positively affects people living with dementia. However, there are a lack of nature-based interventions for people living with mild cognitive impairment or dementia who reside in the community. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Mild Cognitive Impairment
- What is being tested?
- Nature-based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jan 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People living with dementia or mild cognitive impairment (PLWD/MCI)
- Self-reported diagnosis of mild cognitive impairment or dementia (any subtype)
- 18 years old or over
- Has capacity to consent
- Willing to follow the sessions in the manual
- Has a caregiver (family/friend/supporter) that is also willing to take part in the study
Show all 17Show fewer
- Currently residing in the community (e.g. own home, supported accommodation)
- Sufficient command of English to complete questionnaires and to take part in the intervention
- Supporter/caregiver
- An unpaid or informal caregiver, who is caring for a person living with a self-reported diagnosis of mild cognitive impairment or dementia (any subtype) i.e. has at least weekly contact together.
- 18 years old or over
- Has capacity to consent
- The person that they are supporting/caring for is also willing to take part in the study
- Willing to deliver the sessions in the manual
- Willing and able to attend a one-off online caregiver intervention-delivery training session using video conferencing software.
- Currently residing in the community (e.g. own home, supported accommodation)
- Sufficient command of English to complete questionnaires and to deliver the intervention
Who cannot join
- People living with mild cognitive impairment or dementia
- Currently residing in a nursing or care home
- Insufficient command of English to complete questionnaires and to take part in the intervention Supporter/caregiver
- 1. Currently residing in a nursing or care home 2. Insufficient command of English to complete questionnaires and to deliver the intervention
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Human Sciences, Faculty of Education, Health and Human Sciences
London, SE10 9LS
About this study
Official title: You, Me and Nature: A Randomised Pilot Study of a Manualised, Caregiver-led Nature-based Intervention to Improve the Wellbeing of People Living With Mild Cognitive Impairment or Dementia and Their Supporters or Caregivers
Background: Nature positively affects people living with dementia. However, there are a lack of nature-based interventions for people living with mild cognitive impairment or dementia who reside in the community.
Aim: This study is testing a caregiver-led nature-based intervention, which has been co-developed with people living with dementia, supporters/caregivers and professionals, and the study design and set-up will also be evaluated. The results will help provide evidence for whether or not to carry out a larger study in the future and will also contribute to the evidence of nature-based interventions for people living with mild cognitive impairment or dementia.
Read more
Methods: People from the NHS and charities with a diagnosis of mild cognitive impairment or dementia, and their supporters/caregivers (this pair of participants are called a 'dyad') will be approached. The PhD researcher and dyads will meet to discuss the information sheet, answer any questions, then if they'd like to take part, dyads will each complete a consent form and questionnaire asking about demographics, mental health, and service use. A computer will then randomly assign the dyads into the intervention group or waitlist-control group (who will receive the intervention at the end of the study). Supporters/caregivers in the intervention group will attend a one-off online training session on how to use the manual.
The intervention involves 8 weekly sessions of nature-based activities, including a session evaluation sheet to complete for each session. The PhD researcher will call the supporters/caregivers twice during the intervention to check in. At the end of the intervention, dyads will complete another questionnaire each, and then those in the waitlist-control group will have the opportunity to take part in the intervention. There is also an optional interview that dyads can take part in to talk about their experience of the intervention and the study set-up.
- Conditions
- Dementia, Mild Cognitive Impairment
- Being tested
- Nature-based intervention
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature-based interventionOther
The nature-based intervention is a manualised, caregiver-led intervention consisting of a physical manual comprising of 8 sessions of 8 different nature-based activities. It is designed for the person living with dementia or mild cognitive impairment and their caregiver to carry out the sessions together, either in their own home or out in a local area of nature.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will receive the intervention first. Caregivers will attend a one-off training session on how to deliver the intervention. Then the participants will follow the sessions in the intervention manual (8 sessions weekly). Receives: Other: Nature-based intervention |
| Waitlist-control group | Active comparator | Participants will receive the intervention after the intervention group has finished the intervention. Caregivers will attend a one-off training session on how to deliver the intervention. Then the participants will follow the sessions in the intervention manual (8 sessions weekly). Receives: Other: Nature-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wellbeing of the person living with dementia or mild cognitive impairment and their caregiver
As measured by the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) - 14-item. Minimum score = 14, maximum score = 70. Higher score means better wellbeing (better outcome).
Measured: Post-intervention - 8 weeks after the baseline
Secondary outcomes (8)
Change in depression of the person living with dementia or mild cognitive impairment and their caregiver
As measured by the Patient Health Questionnaire-9 (PHQ-9). Minimum score = 0, maximum score = 27. Higher score means higher levels of depression (worse outcome).
Measured: Post-intervention - 8 weeks after the baseline
Change in anxiety of the person living with dementia or mild cognitive impairment and their caregiver
As measured by the Generalised Anxiety Disorder-7 (GAD-7) Minimum score = 0, maximum score = 21. Higher score means higher levels of anxiety (worse outcome).
Measured: Post-intervention - 8 weeks after the baseline
Change in connectedness to nature of the person living with dementia or mild cognitive impairment and their caregiver
As measured by the Nature Relatedness Scale - 21-item (NR-21). Minimum score = 21, maximum score = 105. Higher score means higher connectedness to nature (neither better or worse outcome).
Measured: Post-intervention - 8 weeks after the baseline
Change number of medication used and dosages of the person living with dementia or mild cognitive impairment and their caregiver
As measured using a non-validated questionnaire which was created by the researchers - this is called 'Medication Use'. The non-validated questionnaire asks for the name of the medication, dosage and dose frequency. No minimum or maximum score. Higher use of medication could mean worse outcome.
Measured: Post-intervention - 8 weeks after the baseline
Change in number of services used and types of services used by the person living with dementia or mild cognitive impairment and their caregiver
As measured using the Client Service Receipt Inventory (CSRI). No minimum or maximum score. Higher use of services could mean better or worse outcome.
Measured: Post-intervention - 8 weeks after the baseline
Change in cognition score of the person living with dementia or mild cognitive impairment
as measured by the Addenbrooke's Cognitive Examination - ACE-III (UK Version A - 2017).
Minimum score = 0, maximum score = 100. Higher score means higher levels of cognition (better outcome).
Measured: Post-intervention - 8 weeks after the baseline
Change in positive effects of caregiving score of the caregiver from baseline to post-intervention
As measured by the Gain in Alzheimer care Instrument (GAIN). Minimum score = 0, maximum score = 40. Higher score means higher levels of gains in dementia caregiving (better outcome).
Measured: Post-intervention - 8 weeks after the baseline
Costs of providing the intervention
As measured using a non-validated questionnaire. No minimum or maximum score. Higher costs could mean worse outcome.
Measured: Post-intervention - 8 weeks after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start29 Jan 2025
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harmony Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Harmony Jiang, University of Greenwich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451978
- Sponsor's protocol ID
- VCS-FEHHS-02-22
- Status last verified
- Sep 2025
- First submitted
- 28 May 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- You, Me and Nature: A Randomised Pilot Study of a Manualised, Caregiver-led Nature-based Intervention to Improve the Wellbeing of People Living With Mild Cognitive Impairment or Dementia and Their Supporters or Caregivers
- ClinicalTrials.gov ID
- NCT06451978
- Acronym / sponsor ID
- VCS-FEHHS-02-22
- Conditions
- Dementia, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Harmony JiangUniversity, hospital or other
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 11 Jun 2024 (actual)
- 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.
Background: Nature positively affects people living with dementia. However, there are a lack of nature-based interventions for people living with mild cognitive impairment or dementia who reside in the community.
Aim: This study is testing a caregiver-led nature-based intervention, which has been co-developed with people living with dementia, supporters/caregivers and professionals, and the study design and set-up will also be evaluated. The results will help provide evidence for whether or not to carry out a larger study in the future and will also contribute to the evidence of nature-based interventions for people living with mild cognitive impairment or dementia.
Methods: People from the NHS and charities with a diagnosis of mild cognitive impairment or dementia, and their supporters/caregivers (this pair of participants are called a 'dyad') will be approached. The PhD researcher and dyads will meet to discuss the information sheet, answer any questions, then if they'd like to take part, dyads will each complete a consent form and questionnaire asking about demographics, mental health, and service use. A computer will then randomly assign the dyads into the intervention group or waitlist-control group (who will receive the intervention at the end of the study). Supporters/caregivers in the intervention group will attend a one-off online training session on how to use the manual.
The intervention involves 8 weekly sessions of nature-based activities, including a session evaluation sheet to complete for each session. The PhD researcher will call the supporters/caregivers twice during the intervention to check in. At the end of the intervention, dyads will complete another questionnaire each, and then those in the waitlist-control group will have the opportunity to take part in the intervention. There is also an optional interview that dyads can take part in to talk about their experience of the intervention and the study set-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Nature-based interventionParticipants will receive the intervention first. Caregivers will attend a one-off training session on how to deliver the intervention. Then the participants will follow the sessions in the intervention manual (8 sessions weekly). |
| Waitlist-control group | Active comparator | Other: Nature-based interventionParticipants will receive the intervention after the intervention group has finished the intervention. Caregivers will attend a one-off training session on how to deliver the intervention. Then the participants will follow the sessions in the intervention manual (8 sessions weekly). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- People living with dementia or mild cognitive impairment (PLWD/MCI)
- Self-reported diagnosis of mild cognitive impairment or dementia (any subtype)
- 18 years old or over
- Has capacity to consent
- Willing to follow the sessions in the manual
Key exclusion criteria (4 listed)
- People living with mild cognitive impairment or dementia
- Currently residing in a nursing or care home
- Insufficient command of English to complete questionnaires and to take part in the intervention Supporter/caregiver
- 1. Currently residing in a nursing or care home 2. Insufficient command of English to complete questionnaires and to deliver the intervention
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 |
|---|---|---|
| Nature-based interventionThe nature-based intervention is a manualised, caregiver-led intervention consisting of a physical manual comprising of 8 sessions of 8 different nature-based activities. It is designed for the person living with dementia or mild cognitive impairment and their caregiver to carry out the sessions together, either in their own home or out in a local area of nature. | Other | Intervention group, Waitlist-control group |
Primary outcome
Change in wellbeing of the person living with dementia or mild cognitive impairment and their caregiver
Time frame: Post-intervention - 8 weeks after the baseline
As measured by the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) - 14-item. Minimum score = 14, maximum score = 70. Higher score means better wellbeing (better outcome).
8 secondary outcomes
Change in depression of the person living with dementia or mild cognitive impairment and their caregiver
Time frame: Post-intervention - 8 weeks after the baseline
Change in anxiety of the person living with dementia or mild cognitive impairment and their caregiver
Time frame: Post-intervention - 8 weeks after the baseline
Change in connectedness to nature of the person living with dementia or mild cognitive impairment and their caregiver
Time frame: Post-intervention - 8 weeks after the baseline
Change number of medication used and dosages of the person living with dementia or mild cognitive impairment and their caregiver
Time frame: Post-intervention - 8 weeks after the baseline
Change in number of services used and types of services used by the person living with dementia or mild cognitive impairment and their caregiver
Time frame: Post-intervention - 8 weeks after the baseline
Change in cognition score of the person living with dementia or mild cognitive impairment
Time frame: Post-intervention - 8 weeks after the baseline
Change in positive effects of caregiving score of the caregiver from baseline to post-intervention
Time frame: Post-intervention - 8 weeks after the baseline
Costs of providing the intervention
Time frame: Post-intervention - 8 weeks after the baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature-based intervention in people with Dementia and Mild Cognitive Impairment, run by Harmony Jiang at 1 site in United Kingdom.
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 17 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in wellbeing of the person living with dementia or mild cognitive impairment and their caregiver (time frame: Post-intervention - 8 weeks after the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2025.