NCT04878744

Brief Summary

The aim of the study is to understand how different aspects of city living affect wellbeing. The investigators hope that the results from the study will inform town planners and policy makers about how city spaces can be designed for better health and wellbeing of residents. What? This study will test the use of a new intervention amongst adults with common mental health difficulties such as depression and anxiety. The intervention will be a smartphone app which will prompt users twice a day to notice and record the good things about green spaces or built spaces around Sheffield. Previous research has shown that engaging with the natural environment can benefit health and mental wellbeing. Who? Adults over 18 years old, who have a mild to moderate common mental health problem (such as depression or anxiety), and who own a smartphone will be able to participate. Where? Participants will use the app as part of their day to day routine as they travel around Sheffield and the surrounding area. The app will prompt them to notice green or built spaces around them. How? The app will be delivered as a 'green prescription' which means that health professionals will tell their patients about the intervention. If patients choose to take part, they will be allocated at random to either noticing the good things about green spaces or the good things about built spaces. This is to control for whether noticing green space or noticing other aspects of city life affects health and wellbeing. Patients will complete questionnaires about health, mental wellbeing and their feelings about nature, before, after and 3 months after using the app for one month.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2019

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

9 months

First QC Date

March 19, 2019

Last Update Submit

May 6, 2021

Conditions

Outcome Measures

Primary Outcomes (9)

  • Number of participants completing the study

    Whether the participant remains in the study until post-intervention measures

    post-intervention at 1 month

  • Number of participants who write daily notes

    Whether the participant engages with the app at least 50% of the time by writing notes about the good things they noticed when prompted daily by the app.

    post-intervention at 1 month

  • Change in Recovering Quality of Life scale (Brazier et al., 2014) from baseline to post-intervention

    This is a mental health specific quality of life scale. Possible scores range from 0-40, with higher scores indicating greater quality of life.

    Baseline and post-intervention at 1 month

  • Change in Inclusion of self in nature scale (Schultz, 2001) between baseline and post-intervention

    This is a single item measure of connection to nature. Scores range from 0-100 with higher scores indicating greater nature connection.

    Baseline and post-intervention at 1 month

  • Change in Types of positive affect scale (Gilbert et al., 2009) between baseline and post-intervention

    This scale measures activated and relaxed constructs of positive affect. Higher scores indicate greater positive affect. There are three subscales of Relaxed positive affect (scores range 0-48), Safe positive affect (scores range 0-32) and Activated positive affect (scores range 0-32).

    Baseline and post-intervention at 1 month

  • Change in Nature Relatedness scale (Nisbet & Zelenski 2008) between baseline and post-intervention

    This is a measure of connection to nature. Scores range from 1-30 with higher scores indicating greater nature connection.

    Baseline and post-intervention at 1 month

  • Change in Engagement with Natural Beauty scale (Diessner et al. 2008) between baseline and post-intervention

    This is a measure of noticing natures beauty. Scores range from 1-28, with higher scores indicating greater appreciation of natures beauty.

    Baseline and post-intervention at 1 month

  • Change in EQ-5D-European Quality of Life scale (Rabin, 2001) between baseline and post-intervention

    This is a measure of physical and mental wellbeing. Questions are scored individually and there are four questions. Lower scores indicate better health, so a maximum score of 1 per question indicates optimal health. There is also a visual analogue scale scored 0-100 with 100 indicating the best health score.

    Baseline and post-intervention at 1 month

  • Details about participants visit to green/built spaces

    4 single questions ask about 1) the variety of wildlife or how built-up the area was (responses are none or lots, 2) how that place made them feel (participants respond by clicking a smiley face or a sad face), 3)who they were with (response options include no one, friends/family/partner, Coworker/course mate, in a crowd, pet or other) , and 4) what they were doing (response options include walking, exercising, relaxing, travelling, other).

    post-intervention at 1 month

Study Arms (2)

Noticing the good things about green spaces

EXPERIMENTAL

The intervention condition will prompt participants once a day to notice the good things about green spaces, write notes about the 'good things in nature' and answer 4 questions about the context (e.g. were they alone or in company, exercising or passing through, did they feel comfortable in the place, what were their perceived levels of species variety). Participants were initially asked to use the app for one month. This was found to be associated with poor engagement at feasibility testing and so participants were asked to use the app for 7 days for the evaluation. Both the intervention and active control conditions are based on gratitude interventions. Practicing gratitude in controlled psychological intervention settings has been shown to have lasting effects on dispositional gratitude and psychological wellbeing (Seligman et al. 2005).

Behavioral: Shmapped

Noticing the good things about built spaces

ACTIVE COMPARATOR

In the control condition, participants will not be prompted to notice nature, rather they will be prompted to record the good things about the built environment, write notes about the 'good things in built spaces' and answer 4 questions about the context (e.g. were they alone or in company, exercising or passing through, did they feel comfortable in the place, what were their perceived levels of the area being built-up). Participants were initially asked to use the app for one month. This was found to be associated with poor engagement at feasibility testing and so participants were asked to use the app for 7 days for the evaluation.

Behavioral: Shmapped

Interventions

ShmappedBEHAVIORAL

Novel app-based intervention to improve wellbeing in patients with common mental health problems.

Noticing the good things about built spacesNoticing the good things about green spaces

Eligibility Criteria

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

You may qualify if:

  • Adults over 18 years old
  • Having a mild to moderate common mental health problem (such as depression and/or anxiety)
  • Owning a smartphone

You may not qualify if:

  • Aged under 18 years old
  • Do not have a mild to moderate common mental health problem (depression and/or anxiety)
  • Do not own a smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sheffield

Sheffield, South Yorkshire, S102TN, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The app will be delivered as a 'green prescription' which means that health professionals will tell their patients about the intervention. If patients choose to take part, they will be allocated at random to either noticing the good things about green spaces or the good things about built spaces. This is to control for whether noticing green space or noticing other aspects of city life affects health and wellbeing. Patients will complete questionnaires about health, mental wellbeing and their feelings about nature, before, after and 3 months after using the app for one month.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 19, 2019

First Posted

May 7, 2021

Study Start

April 3, 2017

Primary Completion

January 1, 2018

Study Completion

May 29, 2018

Last Updated

May 7, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

The investigators will not collect any person-identifiable data in this study. None of the demographics data collected, or the participants partial postcode are enough alone or necessarily in combination to identify an individual with any certainty. Tracking data can be sensitive and so the investigators are only collecting the minimum location tracking data to answer the study questions. Ethnicity data is deemed personal by the Data Protection Act and will therefore be stored in a separate database to the remainder of the data and will be linked for analysis using an anonymised linking ID code. Research participants' self-assessed health and wellbeing and perceptions of the natural environment (urban parks and green spaces) will be shared with other researchers via the UK Data Service at the end of the project.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available from 5th June 2019

Locations