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DepressionNCT04210856

Effects of Landscapes on the Brain

A study testing Contemplative landscape exposure in people with Depression and Stress, run by National University of Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Depression, Stress, Anxiety Disorders
What is being tested?
Contemplative landscape exposure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteSingapore
Study dates
28 Feb 2019to 9 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • Institute for Health Innovation & Technology (iHealthtech)

    Singapore, 117599

Other trials in Singapore

About this study

Official title: Effects of Landscapes on the Brain: Assessment of Neurophysiological Response in Healthy and Depressed Individuals to Different Landscape Quality Exposures in Singapore

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.

Read the detailed description

Understanding of the impact of urban green landscapes with different design and levels of contemplativeness on brain function may pave the way to more scientifically informed and more healthy planning and design of urban living environment.

Also the exposure to certain types of landscapes may be useful in mental health promotion and support for the existing treatments in patients with depression.

Specific aims The aim of the study is to assess the effects of passive exposure (viewing) images of differently designed landscapes on the brain activity of two groups: 1) healthy individuals and 2) patients with depression, using electroencephalography (EEG) and Functional Near-Infrared Spectroscopy (fNIRS). The investigators also want to compare effects of exposure to images with the in-situ immersion with the real environment.

Following the assumption that there are certain types and components of the living environments that influence our mental health and well-being even if one is passively exposed to them, the investigators want to to assess the effects of passive exposure to three differently designed, representative landscapes on the brain activity of healthy individuals. And to compare effects of exposure to images with the in-situ immersion with the real environment.

Hypothesis The investigators hypothesise that landscapes, that the Therapeutic Garden, which also achieved a high score in the Contemplative Landscape expert evaluation scale, will induce the brain activity patterns commonly associated with the relaxation, and bottom-up attention, unlike the other selected sites with lower scores. Additionally, the investigators hypothesize that in the real landscape exposures they will observe this phenomenon more intensely than in the case of images exposure.

PARTICIPANTS The investigators will recruit 100 right-handed healthy participants aged 21-75 y.o. Based on previous studies using fNIRS to study motor task (Siedel et al., 2017), the minimum number of participants is 50 participants per group. As a result, recruitment of 100 participants in order to ensure the minimal number of participants in the case of dropouts was proposed.

Exclusion criteria:

  • Left-handedness;
  • serious visual impairment; reported psychiatric, neurological or cognitive diseases;
  • reported use of medication that could alter the functioning of the Central Nervous System at the time of the experiment;
  • existence of a pacemaker, intracranial electrodes, implanted defibrillator or plates,
  • otologic surgery in the last 12 months.

The investigators will also recruit 100 right-handed patients with diagnosed depression at the Neuroscience Clinic or Psychiatric ward in National University Hospital (NUH)

Inclusion criteria:

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

Exclusion criteria:

  • 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.

Recruitment:

The target individuals will be recruited by word of mouth. The principal investigator or co-investigator will approach the participants who fulfil the inclusion criteria and explain the purpose and procedure of this project. If the participant agrees to participate in this project, he or she will sign the consent form after reading the Participant Information Sheet that provides information about this study. Then the investigators will arrange the time schedule to perform the sessions for the participant.

Ethics approvals:

For healthy participants: Ref #: S-18-352 For patients: NHG DSRB Ref # 2018/01036

METHODS NEUROIMAGING EQUIPMENT The NIRS and EEG data will be collected using NIRSport (LLC NIRx Medical Technologies). The former consists of 8 illumination sources and 8 detection sensors with two wavelengths of 760nm \& 850nm, yields 128 data channels, with a sampling rate 62.5 Hz.

The latter is V-Amp 16-channel portable EEG system, with active -dry type of electrodes (actiCAP Xpress), bandwidth of 0Hz (DC) - 500Hz(-3 dB) and sampling rate up to 20.000 Hz. Both devices are lightweight, portable and adjusted to the outdoor environment data collection, and mountable on one single cap to reduce discomforts of long data collection for participants.

EXPERIMENTAL DESIGN

This study is a non-randomised within subjects clinical trial. All participants will attend four landscape viewing sessions while having their brains imaged using the fNIRS and EEG (both machines combined into 1 cap), they will also complete an emotional state assessment questionnaire (Profile of Mood States - POMS, [Shacham,1983]), landscape preference questionnaire (Self-Assessment Manikin) and Beck Depression Inventory (BDI).The latter will serve as a control for the extreme scores in the healthy population i.e. if a healthy patricipants score shows that this participant may suffer from undiagnosed depression their data may be eliminated from the further analysis. The participant with high depression score will be advised to seek clinical assessment by psychiatrist. First session will take place in the research room at the BIGHEART premises (lab indoor environment), and three remaining sessions in the 3 oudoor preselected sites (real landscapes) - see Table 1.

Table 1. Location of the data collection sessions, and estimated time of participation Viewing session Site Adress Estimated Time

  1. Lab (indoors) BIGHEART, 14 Medical Drive, #14-01. 50min
  2. Site 01 (outdoors) Therapeutic Garden @Hortpark, 33 Hyderabad Rd, Singapore 20min
  3. Site 02 (outdoors) Casa Clementi, Clementi Ave 1, Singapore 20min
  4. Site 03 (outdoors) Sheltered sidewalk, 32 New Market Rd, Singapore 20min

Indoor Experimental protocol The first, lab-based session will start with informed consent, and completion of pre-experiment POMS (profile of mood state) questionnaire. The participant code will be then attributed to each participant, their personal information will not be used any more in the study: they will not be needed in the future and will not need to be stored. All electronic devices in the room are to be switched off except necessary data collection equipment. The room temperature and humidity will be kept the same across all participants and conditions. Before the data collection each participant will have the multimodal NIRS and EEG device positioned on their heads.

Participants will be instructed to sit comfortably on a chair and without talking or moving calmly observe the landscape views displayed in front of them, while simultaneously their brain signals will be recorded using NIRS and EEG. Resting state activity for each participant will be recorded preceding the display of the videos.

There will be 1 minute of resting state (baseline) recording followed by the landscape 9 fixed-frame videos viewing, displayed for 20 seconds, repeated 3 times each in a randomized order to avoid order bias. In between the landscapes there will be a fixation cross displayed for 5 seconds. So the overall time of recording EEG/fNIRS signal will take about 13 minutes.

After that four questionnaires will be completed by the participant, including respectively: (1) post-experimental POMS questionnaire, (2) landscape preference questionnaire, (3) Depression scale (BDI questionnaire) and (4) socio-demographic questionnaire. There are some questions that may be deemed sensitive to some participants, in this case they are allowed to skip an uncomfortable question.

The whole procedure (including explanation, consent taking, questionnaire and cognitive tasks) should be completed within 50 min. The fNIRS and EEG signals recorded during landscapes viewing as well as each cognitive task will be stored in the computer.

Outdoor Landscape Experiment multimodal NIRS and EEG In this study participants will be invited to the site session, morning (between 10AM and 12PM) or afternoon (between 2PM and 4PM). For the safety of participants and sound quality of the study design the weather during the session must be normalized: not too hot, dry with clear or partly cloudy sky. In the event of the bad weather conditions (rain, storm, heat wave) the sessions will be postponed. The travel expenses for a participant getting to the sites will be included in the reimbursement.

Because of possibility of disruption of the public space (especially in the case of Site 03), only up to 2 participants can have the session scheduled at the same time.

After completing the pre-experimental POMS questionnaire, participants will be seated in front of an actual landscape view, and advised to calmly observe it, without moving. The researchers will control for the outdoor brightness using the standard light-meter, thus the onsite data collection should be performed at the similar time of a day, with the similar weather conditions and keeping all other factors (such as other visitors and any other distracting phenomena) at the similar levels across all participants.

All the rest of the outdoors experimental procedures will be similar to the laboratory procedure except no consent (the consent signing will take place prior to the outdoors sessions), no socio-demographic and no BDI questionnaire will be performed. Participants will be seated in front of each of 3 landscape views at a location, and for the baseline recording the white glasses will be put on their eyes to cover the view. After baseline recording they will passively watch the landscape view for 1 minutes.

After data collection the devices will be dismounted from the head of participant and the POMS questionnaire will be performed.

The time of the participation in the outdoor session will be therefore shorter, estimated at 20 minutes.

Being tested
Contemplative landscape exposure
Keywords
landscape, exposure, EEG, fNIRS, depression, stress, urban, anxiety, contemplative
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contemplative landscape exposureOther

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

Study groups in NCT04210856
Study groupRoleWhat they receive
Sequence of Landscape exposuresExperimentalAll participants undergo the procedure of visiting all landscape exposures in a random order.
Receives: Other: Contemplative landscape exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EEG power in alpha band

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

    Measured: 5 minutes

  2. EEG power in beta band

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

    Measured: 5 minutes

  3. fNIRS haemodynamics

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

    Measured: 5 minutes

Secondary outcomes (2)
  1. Profile of mood states

    self-reported, pre-and post- stimulation Profile of Mood States (POMS) scale measures the change in the momentary mood, giving as an outcome measure the Total Mood Disturbance (TMD), where 1 is neutral, and above 1 is disturbed mood.

    Measured: 30 minutes

  2. landscape preference measured with self-assessment manikin scale.

    measured using pictorial Self-Asessment Manikin (SAM) where score ranged from -3 to +3, where the lower the score the less positive (valence + arousal) emotions are caused by looking at the view

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2019
  2. Study start28 Feb 2019
  3. Primary completion9 Jul 2021
  4. Study completion9 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
non-randomised within subjects clinical trial.
Masking
None (open label)
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04210856
Sponsor's protocol ID
R-722-000-010-490
Status last verified
Jul 2021
First submitted
19 Dec 2019
Last updated
12 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Contemplative landscape exposure in people with Depression and Stress, run by National University of Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EEG power in alpha band (time frame: 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.

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