You, Me and Nature Pilot Study

NCT06451978 | Active Not Recruiting

• 1 other identifier: VCS-FEHHS-02-22
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dementia; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  Post-intervention - 8 weeks after the baseline

• Change in anxiety of the person living with dementia or mild cognitive impairment and their caregiver

  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

  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

  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

  Post-intervention - 8 weeks after the baseline

Study Arms (2)

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).

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).

Other: Nature-based intervention

Interventions

Nature-based intervention OTHER

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.

Intervention group; Waitlist-control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People living with dementia or mild cognitive impairment (PLWD/MCI)
• Self-reported diagnosis of mild cognitive impairment or dementia (any subtype)
• 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.
• 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.

You may not qualify if:

• 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
• \. Currently residing in a nursing or care home 2. Insufficient command of English to complete questionnaires and to deliver the intervention

Sponsors & Collaborators

• Harmony Jiang: lead

Study Sites (1)

School of Human Sciences, Faculty of Education, Health and Human Sciences

London, SE10 9LS, United Kingdom

Location

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 11, 2024
• Study Start: January 29, 2025
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)