Mental Health IssueNCT04175561
A Dose of Nature: An Interdisciplinary Study of Green Prescriptions
A study testing Green prescription in people with Mental Health Issue and Depression, run by University of Sheffield.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Depression
- What is being tested?
- Green prescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Mental Health Issue, Depression
- Being tested
- Green prescription
- Keywords
- Green prescription, Nature-based health intervention, Nature on prescription, Mental health, Nature connectedness, Nature relatedness, Therapeutic horticulture
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green prescriptionOther
Green prescription intervention will include horticultural activities such as planting, harvesting, learning about ecology and sustainable food growing.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in the intervention arm will be given a green prescription (gardening activities). Receives: Other: Green prescription |
| Control | No intervention | Participants in the control arm will not be given the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9) scale questionnaire assessing change in symptoms of depression
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:
- Mild = 5-9
- Moderate = 10-14 (where a lower score indicates lower level of depression to a minimum score of 5 and a maximum score of 14 for higher levels of depression)
Measured: Baseline (start of study), during (at 6 weeks), and post intervention (at 3 months)
Secondary outcomes (3)
Nature Connectedness Index questionnaire assessing change in level of nature connectedness
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).
Measured: 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
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.
Measured: 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
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).
Measured: Baseline (start of study), during (at 6 weeks), and post intervention (at 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study startMar 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Social prescribing intervention based on RCT design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- Greener Practice, Sheffield, Sheffield Network North Primary Care Network (PCN)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175561
- Sponsor's protocol ID
- IRAS 263091
- Status last verified
- Nov 2019
- First submitted
- 18 Nov 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose of Nature: An Interdisciplinary Study of Green Prescriptions and the Environment-Microbiome-Health Axis
- ClinicalTrials.gov ID
- NCT04175561
- Acronym / sponsor ID
- IRAS 263091
- Conditions
- Mental Health Issue, Depression
- Keywords
- Green prescription, Nature-based health intervention, Nature on prescription, Mental health, Nature connectedness, Nature relatedness, Therapeutic horticulture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- Greener Practice, Sheffield, Sheffield Network North Primary Care Network (PCN)
- Study start
- Mar 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 25 Nov 2019 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Social prescribing intervention based on RCT design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Green prescriptionParticipants in the intervention arm will be given a green prescription (gardening activities). |
| Control | No intervention | –Participants in the control arm will not be given the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Green prescriptionGreen prescription intervention will include horticultural activities such as planting, harvesting, learning about ecology and sustainable food growing. | Other | Intervention |
Primary outcome
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: * Mild = 5-9 * Moderate = 10-14 (where a lower score indicates lower level of depression to a minimum score of 5 and a maximum score of 14 for higher levels of depression)
3 secondary outcomes
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)
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)
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 and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Green prescription in people with Mental Health Issue and Depression, run by University of Sheffield.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
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)). 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 25 Nov 2019.