NCT02225847

Brief Summary

The objective of the research is to test the hypothesis that participating in group-based gardening activities alters brain network activation and function, and that such change occurring in the brain forms the neurobiological basis for much of the nonphysical activity portion of the therapeutic benefits of gardening and horticultural therapy. Assessment of the effects of the gardening activities on the experimental population will take two approaches, the first being the use of functional Magnetic Resonance Imaging (fMRI) to assess the regions of the brain that may become activated as a consequence of experiencing the cumulative gardening activities and associated stimuli. The allied approach will employ widely used and well-established self-reported assessment instruments that will capture information about the health and well-being that will then provide a psychometrically-based before and after physical and health summary of the participants in the control group and those engaged in the gardening activities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

8 months

First QC Date

August 20, 2014

Last Update Submit

May 22, 2019

Conditions

StressDepressionAnxietyQuality of Life

Keywords

GardeningTherapeutic HorticultureFunctional Magnetic Resonance ImagingPsychometric AssessmentStressDepressionAnxietyQuality of LifeWellness

Outcome Measures

Primary Outcomes (1)

  • Change in Spatial Patterns of Brain Network Activation

    Functional magnetic resonance imaging will be employed to assess whether engaging in gardening activities in a greenhouse does or does not alter the spatial patterns of brain network activation relative to changes that occur in the control group.

    Baseline, up to 2 months

Secondary Outcomes (5)

  • Change in Overall Health Status

    Baseline, up to 2 months

  • Change in Depressive Symptomatology

    Baseline, up to 2 months

  • Change in State Anxiety

    Baseline up to 2 months

  • Change in Mood States

    Baseline, up to 2 months

  • Change in Perceived Stress

    Baseline, up to 2 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Members of this group will continue with their daily life activities and will not receive gardening intervention. The control group will be given a set of psychometric assessments for health and quality of life evaluations and undergo a Functional Magnetic Resonance Imaging (fMRI) brain scan, followed by a second round of psychometric assessments and a fMRI brain scan administered seven to eight weeks after the initial baseline psychometric assessments and fMRI brain scan.

Procedure: Functional Magnetic Resonance Imaging (fMRI)Behavioral: psychometric assessments

Gardening

EXPERIMENTAL

Members of this group will be given a set of psychometric assessments for health and quality of life evaluations and a Functional Magnetic Resonance Imaging (fMRI) brain scan prior to receiving the gardening activities intervention. The gardening intervention will consist of twice weekly group sessions lasting 60 minutes in duration that will take place in a greenhouse. The duration of the experimental intervention will be six weeks for a total of 12 individual gardening activity sessions. Following the completion of the gardening intervention, a second round of psychometric assessments and a fMRI brain scan will be administered seven to eight weeks after the initial baseline psychometric assessments and fMRI brain scan.

Other: GardeningProcedure: Functional Magnetic Resonance Imaging (fMRI)Behavioral: psychometric assessments

Interventions

GardeningOTHER

The intervention consists of twice weekly group sessions of gardening activities of 60 minutes in duration that will take place in a greenhouse. A total of 12 gardening sessions administered over a period of six weeks will include planting seeds, bulbs and tubers, transplanting seedlings, vegetative propagation and sight, smell, taste and touch sensory based activities.

Gardening
Functional Magnetic Resonance Imaging (fMRI)PROCEDURE

Functional magnetic resonance imaging will be employed to assess whether engaging in gardening activities in a greenhouse does or does not alter the spatial patterns of brain network activation relative to changes that occur between the groups.

ControlGardening
psychometric assessmentsBEHAVIORAL

The following assessments will be used: The SF-36 Health Survey assessment instrument (Ware and Sherbourne 1992; Hays et al 1993), the Beck Depression Inventory 2nd edition (BDI-II) (Beck et al 1988), The State Trait Anxiety Inventory (STAI) instrument (Form Y) (Spielberger et al 1983), the Profile of Mood States 2nd edition short form for adults instrument (POMS2-AS), and the Perceived Stress Scale (PSS) (Cohen et al 1983) for changes that occur in between the groups.

ControlGardening

Eligibility Criteria

Age26 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal women
  • years of age
  • Not pregnant
  • Non-gardener
  • Non-smoker
  • Good Health
  • Able to participate in all aspects of the study, including working with plants.

You may not qualify if:

  • Uncomfortable in close spaces (claustrophobia)
  • Allergies to plants
  • Allergies to plant parts like pollen
  • Allergies to plant-based foods
  • No additions to alcohol or to recreational drugs or prescription medications
  • Not suffering from recurring pain, and
  • No diseases, disorders or disabilities that affect daily life.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fifield Hall

Gainesville, Florida, 32611, United States

Location

McKnight Brain Institute

Gainesville, Florida, 32611, United States

Location

Wilmot Greenhouse

Gainesville, Florida, 32611, United States

Location

Related Publications (7)

  • Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

    PMID: 1593914BACKGROUND

  • Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305.

    PMID: 8275167BACKGROUND

  • Beck, AT, Steer RA, Garbin MG. Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clinical Psychology Review 1988 (8):77-100.

    BACKGROUND

  • Spielberger, CD, Gorsuch RL, Lushene R. The State-Trait Personality Inventory STAI-Y, form Y. Consulting Psychologists Press, Palo Alto. 1983

    BACKGROUND

  • McNair PM, Lorr M, Droppleman LF. POMS manual (2nd ed.). San Diego: Educational and Industrial Testing Service. 1981.

    BACKGROUND

  • Shacham S. A shortened version of the Profile of Mood States. J Pers Assess. 1983 Jun;47(3):305-6. doi: 10.1207/s15327752jpa4703_14.

    PMID: 6886962BACKGROUND

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PMID: 6668417BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Gardening

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

HorticultureAgricultureTechnology, Industry, and Agriculture

Study Officials

  • Charles L Guy, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2014

First Posted

August 26, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 23, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

At the completion of the study de-identified raw fMRI data from the study will be submitted to OpenfMRI, an open source fMRI database repository located at: https://openfmri.org/. De-identified processed datasets from the brain scans will be submitted to BrainMap or Neurosynth for open source access suitable for meta-analysis of processed fMRI data from brain imaging studies. The URL for BrainMap: http://www.brainmap.org/. The URL for Neurosynth is: http://www.neurosynth.org/.

Locations

US(3)