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.
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
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
- Lab (indoors) BIGHEART, 14 Medical Drive, #14-01. 50min
- Site 01 (outdoors) Therapeutic Garden @Hortpark, 33 Hyderabad Rd, Singapore 20min
- Site 02 (outdoors) Casa Clementi, Clementi Ave 1, Singapore 20min
- 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.
- Conditions
- Depression, Stress, Anxiety Disorders
- 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 group | Role | What they receive |
|---|---|---|
| Sequence of Landscape exposures | Experimental | All 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.
EEG power in alpha band
predictor of positive affect and positive mental health outcomes, measured with EEG
Measured: 5 minutes
EEG power in beta band
more beta in the right temporal lobes associated with stimuli-driven attention, measured with EEG
Measured: 5 minutes
fNIRS haemodynamics
decreased oxy-hemoglobin in the frontal part of the brain indicates more relaxation
Measured: 5 minutes
Secondary outcomes (2)
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
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.
- First posted26 Dec 2019
- Study start28 Feb 2019
- Primary completion9 Jul 2021
- Study completion9 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University Hospital, Singapore, National Parks Board, Singapore, Ministry of National Development, Singapore
- Responsible party
- Principal investigator, Agnieszka Olszewska-Guizzo, National University of Singapore
- Investigators
- Ho Roger, MDD, Principal investigator, NUHS
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Landscapes on the Brain: Assessment of Neurophysiological Response in Healthy and Depressed Individuals to Different Landscape Quality Exposures in Singapore
- ClinicalTrials.gov ID
- NCT04210856
- Acronym / sponsor ID
- R-722-000-010-490
- Conditions
- Depression, Stress, Anxiety Disorders
- Keywords
- landscape, exposure, EEG, fNIRS, depression, stress, urban, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- National University Hospital, Singapore, National Parks Board, Singapore, Ministry of National Development, Singapore
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Lab (indoors) BIGHEART, 14 Medical Drive, #14-01. 50min
- Site 01 (outdoors) Therapeutic Garden @Hortpark, 33 Hyderabad Rd, Singapore 20min
- Site 02 (outdoors) Casa Clementi, Clementi Ave 1, Singapore 20min
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non-randomised within subjects clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Sequence of Landscape exposures | Experimental | Other: Contemplative landscape exposureAll participants undergo the procedure of visiting all landscape exposures in a random order. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 21 to 75
- Right-handed only
- (They must suffer from depressive disorder)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contemplative landscape exposurelandscapes classified as contemplative (through a CLM psychometric measure) are expected to elicit different brainwave oscillations as compared to non-contemplative ones. | Other | Sequence of Landscape exposures |
Primary outcome
EEG power in alpha band
Time frame: 5 minutes
predictor of positive affect and positive mental health outcomes, measured with EEG
EEG power in beta band
Time frame: 5 minutes
more beta in the right temporal lobes associated with stimuli-driven attention, measured with EEG
fNIRS haemodynamics
Time frame: 5 minutes
decreased oxy-hemoglobin in the frontal part of the brain indicates more relaxation
2 secondary outcomes
Profile of mood states
Time frame: 30 minutes
landscape preference measured with self-assessment manikin scale.
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho Roger, MDD principal investigator
NUHS
1 site in 1 country: see every site and its status.
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.