Poor Mental HealthNCT02624921

PHENOTYPE. Therapeutic Study in Barcelona

An observational study of Poor Mental Health and Natural Outdoor Environments, run by Barcelona Institute for Global Health.

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

The study aimed to explore therapeutic effects of natural environments. To do so, the investigators evaluated the immediate and sustained changes in several indicators of well-being while people (n=26) with poor mental health were engaged in unconstrained exposures to natural (green, blue) and urban environments. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Poor Mental Health, Natural Outdoor Environments
How many people: 26 participants
Where: No sites listed yet
Study dates: Oct 2013to Jan 2014
Phase: Observational
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: All the participants (n=26) were individuals that had previously participated in a survey of 1000 people in Barcelona city as part of the PHENOTYPE project. As part of the survey, they had answered the Mental Health Inventory (MHI-5) subscale from the SF-36 health questionnaire. The investigators purposively selected those individuals MHI-5 scored in the lower 50th percentile.

Who may be able to join

MHI-5 scored in the lower 50th percentile of the Barcelona city PHENOTYPE sample
willing to participate

Who cannot join

no able to walk for 30 minutes at self-directed pace.
with chest, abdomen surgery or heart attack during the last three months.
with retinal detachment or eyes surgery or hospitalized for heart problem during the last month.
with tuberculosis treatment, or respiratory infection during the last three weeks.
being asthmatic or pregnant
using inhaler the 24 hours previous to the study day.
taking medication different from the usual the 24 hours previous to the study day.

About this study

Official title: Positive Health Effects of the Natural Outdoor Environment in Typical Populations in Different Regions in Europe. Work Package 4: Therapeutic Study in Barcelona

Each participant was exposed to all environments for a period of 210 minutes between October 2013 and January 2014. During the exposure period, participants were instructed to do what they would usually do in that environment. Before, during (at 30 and 210 minutes) and after each exposure, several psycho-physiological measures were taken: (i) heart rate variability and heart rate using a Holter monitor, (ii) blood pressure using a digital blood pressure monitor, (iii) physical activity using the CalFIT application installed in a Smartphone, (iv) lung function using a portable computerized spirometer, (v) stress level using salivary cortisol samples collected using Salivettes, (vi) affect, perceived restoration and social interactions using questionnaires, (vii) cognitive functioning using the backwards digit-span task test.

Conditions: Poor Mental Health, Natural Outdoor Environments
Being tested: There was no intervention.

What participants receive

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

There was no intervention.Other
Participants were transported one day to a urban setting, one day to a green space, one day to a beach. No intervention was done.

What is being measured

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

Change from Baseline heart rate variability at 30 min
Measured: after 30 minutes of exposure to green/blue/urban environment
Change from Baseline heart rate at 30 min
Measured: after 30 minutes of exposure to green/blue/urban environment
Change from blood pressure at 30min
Measured: after 30 minutes of exposure to green/blue/urban environment
Change from stress level at 30min (salivary cortisol)
Measured: after 30 of exposure to green/blue/urban environment
Change from affect at 30 min (BRUMS/POMS)
Measured: after 30 minutes of exposure to green/blue/urban environment
Change from cognitive functioning at 30 min (backward digit span task)
Measured: after 30 minutes of exposure to green/blue/urban environment
Change from Baseline heart rate variability at 210 min
Measured: after 210 minutes of exposure to green/blue/urban environment
Change from Baseline heart rate at 210 min
Measured: after 210 minutes of exposure to green/blue/urban environment
Change from blood pressure at 210min
Measured: after 210 minutes of exposure to green/blue/urban environment
Change from stress level at 210min (salivary cortisol)
Measured: after 210 minutes of exposure to green/blue/urban environment
Change from affect at 210 min (BRUMS/POMS)
Measured: after 210 minutes of exposure to green/blue/urban environment
Change from cognitive functioning at 210 min (backward digit span task)
Measured: after 210 minutes of exposure to green/blue/urban environment

Secondary outcomes (9)

objectively measured physical activity 30
Measured with a Smartphone application (CalFIT)
Measured: During the first 30 minutes of exposure to green/blue/urban environment
perceived restoration 30 (ROS - Korpela's Restoration outcome scale)
Measured: after 30 minutes of exposure to green/blue/urban environment
subjectively recorded social interactions 30
Measurement tool developed by the research team
Measured: after 30 minutes of exposure to green/blue/urban environment
ambient air pollution exposure 30 (PM2.5)
Measured with MicroAthelometer
Measured: During the first 30 minutes of exposure to green/blue/urban environment
objectively measured physical activity 210
Measured with a Smartphone application (CalFIT)
Measured: During the first 210 minutes of exposure to green/blue/urban environment
perceived restoration 210 (ROS- Korpela's Restoration outcome scale)
Measured: after 210 minutes of exposure to green/blue/urban environment
subjectively recorded social interactions 210
Measurement tool developed by the research team
Measured: after 210 minutes of exposure to green/blue/urban environment
ambient air pollution exposure 210 (PM2.5)
Measured with MicroAthelometer
Measured: During the first 210 minutes of exposure to green/blue/urban environment
personal air pollution (CO, NO, NO2)
Personal sensors designed and built at Cambridge University, UK (CamPerS)
Measured: During all the data collection day

Timeline

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

Oct 2013Jan 2014

First posted9 Dec 2015 (estimated)
Study startOct 2013
Primary completionJan 2014
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Poor Mental HealthStudies of the same condition, open and under way.
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: Observational
Observational model: Case crossover
Time perspective: Prospective
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02624921
Sponsor's protocol ID: PHENOTYPE_WP4BCN
Status last verified: Apr 2018
First submitted: 1 Dec 2015
Last updated: 27 Apr 2018
Results posted: No

Publications

Triguero-Mas M, Gidlow CJ, Martinez D, de Bont J, Carrasco-Turigas G, Martinez-Iniguez T, Hurst G, Masterson D, Donaire-Gonzalez D, Seto E, Jones MV, Nieuwenhuijsen MJ. The effect of randomised exposure to different types of natural outdoor environments compared to exposure to an urban environment on people with indications of psychological distress in Catalonia. PLoS One. 2017 Mar 1;12(3):e0172200. doi: 10.1371/journal.pone.0172200. eCollection 2017.
PubMed 28248974

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Poor Mental Health trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Positive Health Effects of the Natural Outdoor Environment in Typical Populations in Different Regions in Europe. Work Package 4: Therapeutic Study in Barcelona
ClinicalTrials.gov ID: NCT02624921
Acronym / sponsor ID: PHENOTYPE_WP4BCN
Conditions: Poor Mental Health, Natural Outdoor Environments
Study type: Observational
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Barcelona Institute for Global HealthUniversity, hospital or other
Study start: Oct 2013
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 9 Dec 2015 (estimated)
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.

Study design

Observational model: Case crossover
Time perspective: Prospective

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All the participants (n=26) were individuals that had previously participated in a survey of 1000 people in Barcelona city as part of the PHENOTYPE project. As part of the survey, they had answered the Mental Health Inventory (MHI-5) subscale from the SF-36 health questionnaire. The investigators purposively selected those individuals MHI-5 scored in the lower 50th percentile.

Key inclusion criteria (2 listed)

MHI-5 scored in the lower 50th percentile of the Barcelona city PHENOTYPE sample
willing to participate

Key exclusion criteria (7 listed)

no able to walk for 30 minutes at self-directed pace.
with chest, abdomen surgery or heart attack during the last three months.
with retinal detachment or eyes surgery or hospitalized for heart problem during the last month.
with tuberculosis treatment, or respiratory infection during the last three weeks.
being asthmatic or pregnant

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
There was no intervention.Participants were transported one day to a urban setting, one day to a green space, one day to a beach. No intervention was done.	Other	–

Primary outcome

Change from Baseline heart rate variability at 30 min
Time frame: after 30 minutes of exposure to green/blue/urban environment
Change from Baseline heart rate at 30 min
Time frame: after 30 minutes of exposure to green/blue/urban environment
Change from blood pressure at 30min
Time frame: after 30 minutes of exposure to green/blue/urban environment
Change from stress level at 30min (salivary cortisol)
Time frame: after 30 of exposure to green/blue/urban environment
Change from affect at 30 min (BRUMS/POMS)
Time frame: after 30 minutes of exposure to green/blue/urban environment
Change from cognitive functioning at 30 min (backward digit span task)
Time frame: after 30 minutes of exposure to green/blue/urban environment
Change from Baseline heart rate variability at 210 min
Time frame: after 210 minutes of exposure to green/blue/urban environment
Change from Baseline heart rate at 210 min
Time frame: after 210 minutes of exposure to green/blue/urban environment
Change from blood pressure at 210min
Time frame: after 210 minutes of exposure to green/blue/urban environment
Change from stress level at 210min (salivary cortisol)
Time frame: after 210 minutes of exposure to green/blue/urban environment
Change from affect at 210 min (BRUMS/POMS)
Time frame: after 210 minutes of exposure to green/blue/urban environment
Change from cognitive functioning at 210 min (backward digit span task)
Time frame: after 210 minutes of exposure to green/blue/urban environment

9 secondary outcomes

objectively measured physical activity 30
Time frame: During the first 30 minutes of exposure to green/blue/urban environment
perceived restoration 30 (ROS - Korpela's Restoration outcome scale)
Time frame: after 30 minutes of exposure to green/blue/urban environment
subjectively recorded social interactions 30
Time frame: after 30 minutes of exposure to green/blue/urban environment
ambient air pollution exposure 30 (PM2.5)
Time frame: During the first 30 minutes of exposure to green/blue/urban environment
objectively measured physical activity 210
Time frame: During the first 210 minutes of exposure to green/blue/urban environment
perceived restoration 210 (ROS- Korpela's Restoration outcome scale)
Time frame: after 210 minutes of exposure to green/blue/urban environment
subjectively recorded social interactions 210
Time frame: after 210 minutes of exposure to green/blue/urban environment
ambient air pollution exposure 210 (PM2.5)
Time frame: During the first 210 minutes of exposure to green/blue/urban environment
personal air pollution (CO, NO, NO2)
Time frame: During all the data collection day

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 27 Apr 2018.
Derived from this study: PubMed 28248974Triguero-Mas M, Gidlow CJ, Martinez D, de Bont J, Carrasco-Turigas G, Martinez-Iniguez T, Hurst G, Masterson D, Donaire-Gonzalez D, Seto E, Jones MV, Nieuwenhuijsen MJ. The effect of randomised exposure to different types of natural outdoor environments compared to exposure to an urban environment on people with indications of psychological distress in Catalonia. PLoS One. 2017 Mar 1;12(3):e0172200. doi: 10.1371/journal.pone.0172200. eCollection 2017.

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Poor Mental Health and Natural Outdoor Environments, run by Barcelona Institute for Global Health.

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 2 inclusion and 7 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 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Change from Baseline heart rate variability at 30 min (time frame: after 30 minutes of exposure to green/blue/urban environment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02624921, which also lists 1 linked publication.

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 27 Apr 2018.