---
title: You, Me and Nature Pilot Study
nct_id: NCT06451978
overall_status: ACTIVE_NOT_RECRUITING
phase: NA
sponsor: Harmony Jiang
study_type: INTERVENTIONAL
primary_condition: Dementia
countries: United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06451978.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06451978"
ct_last_update_post_date: 2025-09-10
last_seen_at: "2026-05-12T07:33:45.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# You, Me and Nature Pilot 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

**NCT ID:** [NCT06451978](https://clinicaltrials.gov/study/NCT06451978)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 48
- **Lead Sponsor:** Harmony Jiang
- **Conditions:** Dementia, Mild Cognitive Impairment
- **Start Date:** 2025-01-29
- **Completion Date:** 2025-11
- **CT.gov Last Update:** 2025-09-10

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **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).
- **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).

## 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.

## Primary Outcomes

- **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).

## 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)_

## Locations (1)

- School of Human Sciences, Faculty of Education, Health and Human Sciences, London, United Kingdom

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.school of human sciences, faculty of education, health and human sciences|london||united kingdom` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06451978*  
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