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A Dose of Nature: An Interdisciplinary Study of Green Prescriptions

Primary Purpose

Mental Health Issue, Depression

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Green prescription
Sponsored by
University of Sheffield
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Health Issue focused on measuring Green prescription, Nature-based health intervention, Nature on prescription, Mental health, Nature connectedness, Nature relatedness, Therapeutic horticulture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    Participants in the intervention arm will be given a green prescription (gardening activities).

    Participants in the control arm will not be given the intervention.

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    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).
    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.
    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).

    Full Information

    First Posted
    November 18, 2019
    Last Updated
    November 22, 2019
    Sponsor
    University of Sheffield
    Collaborators
    Greener Practice, Sheffield, Sheffield Network North Primary Care Network (PCN)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04175561
    Brief Title
    A Dose of Nature: An Interdisciplinary Study of Green Prescriptions
    Official Title
    A Dose of Nature: An Interdisciplinary Study of Green Prescriptions and the Environment-Microbiome-Health Axis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2020 (Anticipated)
    Primary Completion Date
    September 2020 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Sheffield
    Collaborators
    Greener Practice, Sheffield, Sheffield Network North Primary Care Network (PCN)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Health Issue, Depression
    Keywords
    Green prescription, Nature-based health intervention, Nature on prescription, Mental health, Nature connectedness, Nature relatedness, Therapeutic horticulture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Social prescribing intervention based on RCT design
    Masking
    Outcomes Assessor
    Masking Description
    Analytical blinding is possible, but intervention blinding is not.
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Participants in the intervention arm will be given a green prescription (gardening activities).
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Participants in the control arm will not be given the intervention.
    Intervention Type
    Other
    Intervention Name(s)
    Green prescription
    Intervention Description
    Green prescription intervention will include horticultural activities such as planting, harvesting, learning about ecology and sustainable food growing.
    Primary Outcome Measure Information:
    Title
    Patient Health Questionnaire-9 (PHQ-9) scale questionnaire assessing change in symptoms of depression
    Description
    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)
    Time Frame
    Baseline (start of study), during (at 6 weeks), and post intervention (at 3 months)
    Secondary Outcome Measure Information:
    Title
    Nature Connectedness Index questionnaire assessing change in level of nature connectedness
    Description
    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).
    Time Frame
    Baseline (start of study), during (at 6 weeks), and post intervention (at 3 months)
    Title
    Perceived Stress Scale (PSS) questionnaire assessing change in symptoms of stress
    Description
    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.
    Time Frame
    Baseline (start of study), during (at 6 weeks), and post intervention (at 3 months)
    Title
    Warwick and Edinburgh Mental Wellbeing Scale (WEMWBS) assessing change in levels of wellbeing
    Description
    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).
    Time Frame
    Baseline (start of study), during (at 6 weeks), and post intervention (at 3 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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    A Dose of Nature: An Interdisciplinary Study of Green Prescriptions

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