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

NCT06205940 | Not Yet Recruiting DMC

• 1 other identifier: 101081420
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mobility Disability

Keywords

nature app; nature connection; forest walks; mobility disability; resilience; eyetracking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• the State Mindfulness Scale

  Baseline 1 (just before intervention), After tour on intervention day 1, End of intervention (after 4 months)

• The Restorative Outcome Scale

  After tour on intervention day 1, End of intervention (after 4 months)

• The Subjective Vitality Scale

  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

  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

  During tour on intervention day 1

Other Outcomes (2)

• Eye-tracking

  During tour on intervention day 1

• System Usability Scale

  After tour on intervention day 1

Study Arms (2)

Audio guided nature tour

EXPERIMENTAL

Listening to audio instructions by an app while visiting nature.

Behavioral: Audioguided Nature tour

Non audio guided nature tour

ACTIVE COMPARATOR

Visiting nature without audio guided instructions (app).

Behavioral: Non audio guided nature tour

Interventions

Audioguided Nature tour BEHAVIORAL

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 tour

Non audio guided nature tour BEHAVIORAL

Visiting nature without listening to audio instructions by an app

Non audio guided nature tour

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Officials

• Ulrika K Stigsdotter, PHD

  University of Copenhagen - IGN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrika K Stigsdotter, PHD

CONTACT

40110801; uks@ign.ku.dk

Sus S Corazon, PDH

CONTACT

61680921; suoe@ign.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 16, 2024
• Study Start: June 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: April 30, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: 2025 to 2028
• 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.