NCT04210856

Brief Summary

There is an established consensus between researchers that the contact with natural environments has beneficial influence on mental health and well-being of people exposed to them. The knowledge in this area is based mostly on the correlational analyses, but more research is needed to explore the causal relationships between the human and his environment. More specifically, in order to identify specific restorative mechanisms in response to the specific types and components of the designed landscapes, especially in the highly urbanized context. This study will attempt to find the psychophysiological responses in human brain to landscapes videos (in the lab), and real landscapes with different visual quality, carefully pre-selected and analysed in terms of landscape composition. In the study the rigorous experimental protocol will be administered in order to acquire qualitative and quantitative data both self-reported and measured by neuroscience tools, in order to demonstrate the causal effect of landscape exposure on the brain activity patterns and mood of healthy and depressed individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable depression

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

February 28, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2021

Completed
Last Updated

July 12, 2021

Status Verified

July 1, 2021

Enrollment Period

2.4 years

First QC Date

December 19, 2019

Last Update Submit

July 9, 2021

Conditions

Keywords

landscapeexposureEEGfNIRSdepressionstressurbananxietycontemplative

Outcome Measures

Primary Outcomes (3)

  • EEG power in alpha band

    predictor of positive affect and positive mental health outcomes, measured with EEG

    5 minutes

  • EEG power in beta band

    more beta in the right temporal lobes associated with stimuli-driven attention, measured with EEG

    5 minutes

  • fNIRS haemodynamics

    decreased oxy-hemoglobin in the frontal part of the brain indicates more relaxation

    5 minutes

Secondary Outcomes (2)

  • Profile of mood states

    30 minutes

  • landscape preference measured with self-assessment manikin scale.

    30 minutes

Study Arms (1)

Sequence of Landscape exposures

EXPERIMENTAL

All participants undergo the procedure of visiting all landscape exposures in a random order.

Other: Contemplative landscape exposure

Interventions

landscapes classified as contemplative (through a CLM psychometric measure) are expected to elicit different brainwave oscillations as compared to non-contemplative ones.

Sequence of Landscape exposures

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 21 to 75
  • Right-handed only
  • (They must suffer from depressive disorder)

You may not qualify if:

  • Major neurological disorders e.g. epilepsy, stroke
  • Any form of cancer
  • Major heart diseases: e.g. ischemic heart disease
  • Major lung diseases: e.g. chronic obstructive pulmonary disorder.
  • Major liver disease e.g. liver failure
  • Major kidney disease e.g. kidney failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Health Innovation & Technology (iHealthtech)

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Ho Roger, MDD

    NUHS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
participants do not know the hypothesis of a study, other people cannot influence the brainwave reaction
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: non-randomised within subjects clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2019

First Posted

December 26, 2019

Study Start

February 28, 2019

Primary Completion

July 9, 2021

Study Completion

July 9, 2021

Last Updated

July 12, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations