HealthyNCT05362552
Effects of Urban Afforestation Activity on Mental Health
A study testing Urban Afforestation Program in people with Healthy, run by Universidad de Granada at 1 site in Spain.
Trial summary
This single-group pretest-posttest clinical trial aims to evaluate the effects of a single-session afforestation activity on affect and vitality levels in a sample of young adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Urban Afforestation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteSpain
- Study dates
- 9 May 2022to 20 May 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults between 18 and 65 years.
- Any sex and gender.
Who cannot join
- Intake of any psychotropic medication.
- Other severe or medically unstable diseases that may interfere with participation.
- Severe cognitive impairment (Mini-Mental State Examination score < 17 out of 30 points).
- Severe mental disorders in the acute phase or symptomatic phase.
- Severe intellectual disability.
- Behavioural alterations as this may interfere with their participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Positive Effects of an Urban Afforestation Activity on the Mental Health of Adults
This single-group pretest-posttest clinical trial aims to evaluate the effects of a single-session afforestation activity on affect and vitality levels in a sample of young adults.
Read the detailed description
The participants will perform an afforestation activity for a single session of 90 minutes. The therapists will direct the participants' attention to the visual, auditory, olfactory, and tactile features of the surrounding environment.
- Conditions
- Healthy
- Being tested
- Urban Afforestation Program
- Keywords
- Green spaces, Nature-based activities, Urban afforestation, Horticultural therapy, Adults, Mental health, Affect, Vitality
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urban Afforestation ProgramOther
Also called Nature-based activity, Afforestation activity
An afforestation program based on land cultivation and transplantation of several plants for 90 minutes will be implemented.
| Study group | Role | What they receive |
|---|---|---|
| Urban Afforestation Group | Experimental | Participants will perform an afforestation activity with a duration of 90 minutes. Receives: Other: Urban Afforestation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affect
The Spanish adaptation of the Positive and Negative Affect Schedule will be utilised. Participants rate how they feel at the present moment on a five-point Likert scale, where "not at all or very slightly" is scored as 1 and "a lot" as 5. Scores of two 10-item subscales will be analysed separately in the analysis, labelled either as Positive Affect or Negative Affect. Higher scores in the Positive Affect subscale represent higher levels of positive affect and lower scores in the Negative Affect subscale represent lower levels of negative affect.
Measured: Change from baseline affect after 90 minutes.
Subjective Vitality
The 6-item Spanish adaptation of the Subjective Vitality Scale will be utilised. Participants will transmit their levels of energy and aliveness at the present moment by rating the items on a seven-point Likert scale where 1 stands for "Not true at all" and 7 "Very true". The scores for each item will be summed up for statistical analyses. Higher scores indicate higher levels of energy and aliveness feeling.
Measured: Change from baseline subjective vitality after 90 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start9 May 2022
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Manuel Pérez Mármol, Universidad de Granada
- Investigators
- José Manuel PÉREZ-MÁRMOL, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362552
- Sponsor's protocol ID
- AfforestAffect
- Status last verified
- May 2022
- First submitted
- 2 May 2022
- Last updated
- 23 May 2022
- 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 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Positive Effects of an Urban Afforestation Activity on the Mental Health of Adults
- ClinicalTrials.gov ID
- NCT05362552
- Acronym / sponsor ID
- AfforestAffect
- Conditions
- Healthy
- Keywords
- Green spaces, Nature-based activities, Urban afforestation, Horticultural therapy, Adults, Mental health, Affect, Vitality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 5 May 2022 (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.
This single-group pretest-posttest clinical trial aims to evaluate the effects of a single-session afforestation activity on affect and vitality levels in a sample of young adults.
Detailed description
The participants will perform an afforestation activity for a single session of 90 minutes. The therapists will direct the participants' attention to the visual, auditory, olfactory, and tactile features of the surrounding environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urban Afforestation Group | Experimental | Other: Urban Afforestation ProgramParticipants will perform an afforestation activity with a duration of 90 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults between 18 and 65 years.
- Any sex and gender.
Key exclusion criteria (6 listed)
- Intake of any psychotropic medication.
- Other severe or medically unstable diseases that may interfere with participation.
- Severe cognitive impairment (Mini-Mental State Examination score < 17 out of 30 points).
- Severe mental disorders in the acute phase or symptomatic phase.
- Severe intellectual disability.
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 |
|---|---|---|
| Urban Afforestation ProgramAlso: Nature-based activity, Afforestation activityAn afforestation program based on land cultivation and transplantation of several plants for 90 minutes will be implemented. | Other | Urban Afforestation Group |
Primary outcome
Affect
Time frame: Change from baseline affect after 90 minutes.
The Spanish adaptation of the Positive and Negative Affect Schedule will be utilised. Participants rate how they feel at the present moment on a five-point Likert scale, where "not at all or very slightly" is scored as 1 and "a lot" as 5. Scores of two 10-item subscales will be analysed separately in the analysis, labelled either as Positive Affect or Negative Affect. Higher scores in the Positive Affect subscale represent higher levels of positive affect and lower scores in the Negative Affect subscale represent lower levels of negative affect.
Subjective Vitality
Time frame: Change from baseline subjective vitality after 90 minutes.
The 6-item Spanish adaptation of the Subjective Vitality Scale will be utilised. Participants will transmit their levels of energy and aliveness at the present moment by rating the items on a seven-point Likert scale where 1 stands for "Not true at all" and 7 "Very true". The scores for each item will be summed up for statistical analyses. Higher scores indicate higher levels of energy and aliveness feeling.
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 23 May 2022.
- 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.
José Manuel PÉREZ-MÁRMOL, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urban Afforestation Program in people with Healthy, run by Universidad de Granada at 1 site in Spain.
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 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 23 May 2022. 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 Spain. 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?
Affect (time frame: Change from baseline affect after 90 minutes.). The study lists 2 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 23 May 2022.