Building Individual and Community Resilience Through Nature-based Therapies - Case Study 8 Nature for All (RESONATE-CS8)

Building Individual and Community Resilience Through Nature-based Therapies - Case Study 8

The aim of this randomized controlled trial is to test if digital engagement instructions (a nature guide APP) can enhance the nature connection and provide positive health outcomes for individuals with mobility disabilities.

The study has an active control group, that will have the same nature exposure without the guidance of the APP. 124 participants will be randomized to either the intervention group or the control group.

The intervention consists of two parts:

Intervention day 1: The intervention starts for both the 'intervention group' and the 'control group' in the Hoersholm arboretum, which contain Denmark's largest collection of different trees and shrubs. The intervention group will listen to the 'intervention APP' during a tour with three stops along a trail in the arboretum. The active control group will take the same tour but does not have access to the 'intervention APP'.

4 week intervention: During the following 4 weeks the participants will be encouraged to visit nature for 120 minutes in total per week on their own. The intervention group will still be encouraged to use the APP during the nature visits.

Study Overview

• Status: Not yet recruiting
• Conditions: Mobility Disability
• Intervention / Treatment: Behavioral: Audioguided Nature tour; Behavioral: Non audio guided nature tour

Detailed Description

See protocol

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ulrika K Stigsdotter, PHD; Phone Number: +45 40110801; Email: uks@ign.ku.dk
• Study Contact Backup: Name: Sus S Corazon, PDH; Phone Number: +45 61680921; Email: suoe@ign.ku.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Not being able to walk at all or be able to walk short distances (ICF 2017: d4500, walking short distances; walking for less than a kilometer, such as walking around rooms or hallways, within a building or for short distances outside)
• All types of assistive devices, including e.g. scooters, walkers, and canes. Also service dogs and personal carers are included.
• Adults (+18 years)
• All genders
• All educational levels
• All religious affiliations
• All types of marital status
• All types of households
• All types of employment and income

Exclusion Criteria:

• - Do not understand Danish (APP, questionnaires and interviews in Danish)
• Physically not able to use a smartphone with touch screen, by themselves or with the help of a personal carer
• Participating in mindfulness program during intervention (intervention day 1 and 4-week intervention period)
• Cognitive limitations (difficulties in understanding and using information from APP, understanding and responding to questionnaires and interviews.)
• Known drug or alcohol abuse
• Diagnosed epilepsy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Audio guided nature tour; Listening to audio instructions by an app while visiting nature.	Behavioral: Audioguided Nature tour; Listening to audio instructions by an app while visiting nature. The instructions emphasize the connection between self and nature and direct attention to the present moment experience by guiding focus towards sensory experiences and specific natural elements.
Active Comparator: Non audio guided nature tour; Visiting nature without audio guided instructions (app).	Behavioral: Non audio guided nature tour; Visiting nature without listening to audio instructions by an app

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Nature Connection Index	Questionnaire Nature Connection Index (NCI) is a 6-item self-report measure of connection to nature. The level of agreement with each of the 6 statements is rated on a scale from 1 (completely agree) to 7 (completely disagree), where a higher score indicates higher level of nature connection.	Baseline 0 (1 week before intervention), After intervention day 1, End of intervention (after 4 months), 1 month follow-up, 3 month-follow up, 6-months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Variability	HRV analysis will be performed on electrocardiograms, ECG signals	During tour on intervention day 1
the State Mindfulness Scale	The State Mindfulness Scale (SMS) is a 21-item self-report measure of state mindfulness. The level of agreement with each of the 21 statements is rated on a scale from 1 (not at all) to 5 (very much), where a higher score indicates higher level of state mindfulness.	Baseline 1 (just before intervention), After tour on intervention day 1, End of intervention (after 4 months)
The Restorative Outcome Scale	The Restorative Outcome Scale (ROS) is a 6-item self-report measure of the restorative effect of natural environments. The level of agreement with each of the six statement is rated on a 7 point scale from 0 (completely disagree) to 6 (completely agree), where a higher score indicates higher level of self perceived restorative outcome.	After tour on intervention day 1, End of intervention (after 4 months)
The Subjective Vitality Scale	The Subjective Vitality Scale (SVS) is a 6-item self-report measure of subjective vitality. The level of agreement with each of the six statement is rated on a 7 point scale from 1(completely disagree) to 7 (completely agree), where a higher score indicates higher level of subjective vitality.	Baseline 0 (1 week before intervention), After intervention day 1, End of intervention (after 4 months), 1 month follow-up, 3 month-follow up, 6-months follow-up
The State-Trait Assessment of Resilience Scale	The State-Trait Assessment of Resilience Scale (STARS) is a 7-item self-report measure of resilience. The level of agreement with each of the 7 statements is rated on a 4 point scale from 1(disagree) to 4 (completely agree). Item 3,4,5 have reverse scoring. A higher score indicates higher level of subjective vitality.	Baseline 0 (1 week before intervention), After intervention day 1, End of intervention (after 4 months), 1 month follow-up, 3 month-follow up, 6-months follow-up
The Health-related Quality of Life Short Form Survey	The Health-related Quality of Life Short Form Survey (SF-12) is a 12-item Short Form Survey measuring health related quality of life. Each question is answered on a 6 point scale ranging from not at all (1) to all the time (6). A higher total score indicates higher level of health-related quality of life.	Baseline 0 (1 week before intervention), End of intervention (after 4 months), 1 month follow-up, 3 month-follow up, 6-months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eye-tracking	Portable eye-tracking recording	During tour on intervention day 1
System Usability Scale	The System Usability Scale (SUS) consists of 10 question, scored on a 5 point likert scale ranging from strongly disagree (0) to strongly agree (4), where item 2,4,6,8 and 10 have reverse scoring. A higher score indicate higher level of perceived usability.	After tour on intervention day 1

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Investigators: Principal Investigator: Ulrika K Stigsdotter, PHD, University of Copenhagen - IGN

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: resilience; eyetracking; mobility disability; nature app; nature connection; forest walks
• Other Study ID Numbers: 101081420

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data is shared exclusively in pseudonymized form with all partners in the RESONATE project. The countries included in RESONATE are: Denmark, Spain, Italy, Belgium, Sweden, Bulgaria, Austria, and the Netherlands. The UK is an associated partner.
• IPD Sharing Time Frame: 2025 to 2028

IPD Sharing Access Criteria

The RESONATE project is currently developing a Joint Control Agreement which is an arrangement on shared responsibility for data processing, which determines in a transparent manner the partner's respective responsibilities for GDPR compliance. Signing this agreement allows results to be shared freely within the consortium. Thus, the RESONATE partners would not need separate Data Sharing or Data Transfer agreements with each partner.

The General Data Protection Regulation (GDPR) is enforced in all EU countries and also in the UK. All partners in the consortium need to follow the GDPR.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No