- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04175561
A Dose of Nature: An Interdisciplinary Study of Green Prescriptions
A Dose of Nature: An Interdisciplinary Study of Green Prescriptions and the Environment-Microbiome-Health Axis
The idea that spending time in natural environments can enhance one's health has been researched for several years. However, the concept of green prescribing--or prescribing a systematic nature-based intervention that can be monitored over time--has only recently generated traction in practice (although the principles can be traced back to several hundred years ago).
Green prescriptions (social prescribing with nature) could potentially help to reduce the costs of mainstream healthcare and could have important 'co-benefits', for example, by simultaneously enhancing the environment.
There are still a number of critical questions that need answering, such as what works best for whom, where and when, and a number of key constraints need to be addressed. The conceptual framework for this proposed trial has been informed by the results of a UK-wide green prescribing questionnaire (Stage 1 of PhD) and recommendations from the Improving Wellbeing through Urban Nature (IWUN) research project (www.iwun.uk).
The main (perceived) constraints to green prescribing acquired from the questionnaire include:
- A lack of funding for all stakeholders
The research project aims to be cost-effective and not strictly reliant on other organisations
- A lack of knowledge of how to start a green prescribing service
The project aims to demonstrate how to start a green prescribing service
- A lack of opportunities and awareness of service availability
As above
- Patient motivation and ease of access/travel etc.
The novel situational aspect of the project (within the premises of GP practices) aims to maximise access/minimise travel for patients
- A lack of knowledge of the evidence and mechanisms
The research project aims to collect evidence on mental health, wellbeing and nature connectedness via an RCT-style experimental design
- Referral and set-up time
- As per funding objective - see top. The research project will also evaluate patient appointments/attendances (number and frequency) via the RCT approach
The researcher is proposing to conduct a 3-6 month randomised controlled trial (RCT) interventional study involving adult patients with mild-moderate depression as determined using the well-established PHQ-9 questionnaire. A key aim is to sustain this green prescribing service once the research is complete and to hopefully stimulate other trials across Sheffield and the UK (providing opportunities for important meta-analyses).
The intervention will include pocket gardening (activities in small, semi-permanent, versatile gardens) and nature-based activities hosted in the premises of GP surgeries in Sheffield's Network North region.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A green prescription is a prescribed nature-based health intervention designed for individuals with a defined need (or to complement orthodox medical treatments). Common examples of green prescribing activities include: therapeutic horticulture, biodiversity conservation volunteering, care farming, wild crafts and nature walks. Green prescriptions are typically provided for a set length of time (e.g. 12 weeks) but can be open ended.
As a green prescribing activity, therapeutic horticulture has several potential benefits including physical and mental health improvements, facilitating social co-mingling, educational and reward-based e.g. harvesting natural produce. It has already proven successful as a green prescribing activity in projects such as SAGE Greenfingers (sagesheffield.org.uk), which was established following a community needs assessment commissioned by Pitsmoor surgery in Sheffield.
This kind of green prescription provides natural environmental features, social context and meaningful activities - three important interacting phenomena in nature-based interventions. By integrating other nature-based activities such as simply noticing the local wildlife, this project also aims to open pathways (via senses, compassion, emotion meaning and beauty) to nature connectedness - one's emotional relationship with the natural world. The novel situational element of this project (i.e. hosted in GP surgery premises) aims to maximise accessibility and minimise travel for the patients, and to minimise multi-stakeholder logistics.
Furthermore, several policy statements--informed by empirical evidence--were recently published by the IWUN research project (www.iwun.uk). Amongst many other recommendations, these call for GP practices to enhance the biodiversity in their premises.
Importantly, the question of how GP practices can provide their own greenspaces to improve the mental health of their patients is also raised.
Re-designing the outdoor spaces surrounding GP practices and/or integrating new nature-based features and activities within these spaces could help to enhance patient (and staff) wellbeing. Creating pocket gardens (small multifunctional gardens typically installed in the pockets of empty urban spaces) and biodiverse spaces for green prescribing activities is one potential route, and an evaluation of this concept forms the basis of the research project.
There is also a severe lack of randomised controlled trial experiments in green prescribing research - further strengthening the rationale for the chosen experimental approach.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Only adults - over 18 years of age with mild-moderate depression.
- Patients will be residents of North Sheffield and part of the Network North Primary Care Network (PCN).
- Patients will preferably be comfortable with outdoors and social settings.
Exclusion Criteria:
- Those who are not adults - over 18 years of age with mild-moderate depression.
- Patients who are not residents of North Sheffield and part of the Network North Primary Care Network (PCN).
- Patients who are not comfortable with outdoors and social settings.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Participants in the intervention arm will be given a green prescription (gardening activities).
|
Green prescription intervention will include horticultural activities such as planting, harvesting, learning about ecology and sustainable food growing.
|
No Intervention: Control
Participants in the control arm will not be given the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire-9 (PHQ-9) scale questionnaire assessing change in symptoms of depression
Time Frame: Baseline (start of study), during (at 6 weeks), and post intervention (at 3 months)
|
Results of Patient Health Questionnaire-9 scale questionnaire (determining level of depression) will be the primary outcome measure. The PHQ-9 severity cut-off for this study will be as follows:
|
Baseline (start of study), during (at 6 weeks), and post intervention (at 3 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nature Connectedness Index questionnaire assessing change in level of nature connectedness
Time Frame: Baseline (start of study), during (at 6 weeks), and post intervention (at 3 months)
|
Results from the Nature Connectedness Index questionnaire to determine level of nature connectedness.
This instrument comprises 6 questions and a 7-point response scale from "completely agree" to "completely disagree" (where 0 is lowest score of nature connectedness and 42 is the maximum score).
|
Baseline (start of study), during (at 6 weeks), and post intervention (at 3 months)
|
Perceived Stress Scale (PSS) questionnaire assessing change in symptoms of stress
Time Frame: Baseline (start of study), during (at 6 weeks), and post intervention (at 3 months)
|
Results from the Perceived Stress Scale questionnaire. This is a 10-point measure using a 0-4 Likert style response system. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. |
Baseline (start of study), during (at 6 weeks), and post intervention (at 3 months)
|
Warwick and Edinburgh Mental Wellbeing Scale (WEMWBS) assessing change in levels of wellbeing
Time Frame: Baseline (start of study), during (at 6 weeks), and post intervention (at 3 months)
|
Results from the Warwick and Edinburgh Mental Wellbeing Scale.
The Warwick and Edinburgh Mental Wellbeing Scale has 14 x statements and 5 x response categories, summed to provide a single score (where 14 is the lowest score of wellbeing and 70 is the maximum).
|
Baseline (start of study), during (at 6 weeks), and post intervention (at 3 months)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRAS 263091
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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