NCT04175561

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

November 18, 2019

Last Update Submit

November 22, 2019

Conditions

Keywords

Green prescriptionNature-based health interventionNature on prescriptionMental healthNature connectednessNature relatednessTherapeutic horticulture

Outcome Measures

Primary Outcomes (1)

  • 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)

    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

    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

    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

    Baseline (start of study), during (at 6 weeks), and post intervention (at 3 months)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Green prescription

Control

NO INTERVENTION

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

Interventions

Green prescription intervention will include horticultural activities such as planting, harvesting, learning about ecology and sustainable food growing.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Analytical blinding is possible, but intervention blinding is not.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Social prescribing intervention based on RCT design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 25, 2019

Study Start

March 1, 2020

Primary Completion

September 1, 2020

Study Completion

December 1, 2021

Last Updated

November 25, 2019

Record last verified: 2019-11