NCT05384301

Brief Summary

This single-group pretest-posttest clinical trial aims to evaluate the effects of a single-session afforestation activity on mood, stress, and anxiety in a sample of adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started May 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

May 25, 2022

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2022

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

11 days

First QC Date

May 17, 2022

Last Update Submit

June 5, 2022

Conditions

Keywords

Green spacesNature-based activitiesUrban afforestationHorticultural therapyMental healthMoodStressAnxiety

Outcome Measures

Primary Outcomes (1)

  • Mood

    The Spanish adaptation of the 30-item Short Form of the Profile of Mood States will be utilised. There are five questions situated under each mood factor of Anger, Fatigue, Vigour, Friendliness, Tension, and Depressed Mood, which will be rated on a five-point scale starting from 0 indicating "not at all" up to 4 indicating "a lot" to evaluate the current feelings. Higher scores on the vigour and friendliness subscale indicate more positive mood, and higher scores on the remaining subscales indicate more negative mood.

    Change from baseline the total mood disturbance after 90 minutes.

Secondary Outcomes (2)

  • State stress

    Change from baseline state stress after 90 minutes.

  • State anxiety

    Change from baseline state anxiety after 90 minutes.

Study Arms (1)

Urban Afforestation Group

EXPERIMENTAL

Participants will perform an afforestation activity with a duration of 90 minutes.

Other: Urban Afforestation Program

Interventions

An afforestation program based on land cultivation and transplantation of several plants for 90 minutes will be implemented.

Also known as: Nature-based activity, Afforestation activity
Urban Afforestation Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults between 18 and 65 years.
  • Any sex and gender.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Granada, Faculty of Health Sciences

Granada, Andalusia, 18071, Spain

Location

MeSH Terms

Conditions

Psychological Well-BeingAnxiety Disorders

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorMental Disorders

Study Officials

  • José Manuel PÉREZ-MÁRMOL, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 17, 2022

First Posted

May 20, 2022

Study Start

May 25, 2022

Primary Completion

June 5, 2022

Study Completion

June 5, 2022

Last Updated

June 7, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations