You, Me and Nature Pilot Study

September 2, 2025 updated by: Harmony Jiang

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.

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE10 9LS
        • School of Human Sciences, Faculty of Education, Health and Human Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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
  • 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

Exclusion Criteria:

People living with mild cognitive impairment or dementia

  1. Currently residing in a nursing or care home
  2. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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).
Other: Nature-based intervention
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.
Active Comparator: Waitlist-control group
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).
Other: Nature-based intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Post-intervention - 8 weeks after the baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
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
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).
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
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).
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
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.
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
As measured using the Client Service Receipt Inventory (CSRI). No minimum or maximum score. Higher use of services could mean better or worse outcome.
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

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).
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
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).
Post-intervention - 8 weeks after the baseline
Costs of providing the intervention
Time Frame: Post-intervention - 8 weeks after the baseline
As measured using a non-validated questionnaire. No minimum or maximum score. Higher costs could mean worse outcome.
Post-intervention - 8 weeks after the baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harmony Jiang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCS-FEHHS-02-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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