- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06205940
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
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
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Audio guided 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.
|
Audio guided nature walks versus non guided nature walks
|
Active Comparator: Non audio guided nature tour
Visiting nature without listening to audio instructions.
|
Audio guided nature walks versus non guided nature walks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nature Connection Index (NCI)
Time Frame: 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
|
6-item self-report measure of connection to nature
|
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 |
---|---|---|
State Mindfulness Scale (SMS)
Time Frame: Baseline 1 (just before intervention), After tour on intervention day 1, End of intervention (after 4 months)
|
21-item self-report measure of state mindfulness
|
Baseline 1 (just before intervention), After tour on intervention day 1, End of intervention (after 4 months)
|
Restorative Outcome Scale (ROS)
Time Frame: After tour on intervention day 1, End of intervention (after 4 months)
|
6-item self-report measure of the restorative effect of natural environments
|
After tour on intervention day 1, End of intervention (after 4 months)
|
Subjective Vitality Scale (SVS)
Time Frame: 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
|
6-item self-report measure 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
|
State-Trait Assessment of Resilience Scale (STARS).
Time Frame: 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
|
10-item self-report measure of resilience
|
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
|
Heart Rate Variability
Time Frame: During tour on intervention day 1
|
HRV analysis will be performed on electrocardiograms, ECG signals
|
During tour on intervention day 1
|
Health-related Quality of Life Short Form Survey (SF-12)
Time Frame: Baseline 0 (1 week before intervention), End of intervention (after 4 months), 1 month follow-up, 3 month-follow up, 6-months follow-up
|
12-item Short Form Survey measuring 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
Time Frame: During tour on intervention day 1
|
Portable eye-tracking recording
|
During tour on intervention day 1
|
System Usability Scale (SUS)
Time Frame: After tour on intervention day 1
|
test the usability of the Intervention APP
|
After tour on intervention day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ulrika K Stigsdotter, PHD, University of Copenhagen - IGN
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 101081420
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
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
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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