<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02225847</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201400425</org_study_id>
    <nct_id>NCT02225847</nct_id>
  </id_info>
  <brief_title>Effect of Gardening on Brain Activity</brief_title>
  <official_title>Effect of Gardening on Brain Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Foliage Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the research is to test the hypothesis that participating in group-based&#xD;
      gardening activities alters brain network activation and function, and that such change&#xD;
      occurring in the brain forms the neurobiological basis for much of the nonphysical activity&#xD;
      portion of the therapeutic benefits of gardening and horticultural therapy. Assessment of the&#xD;
      effects of the gardening activities on the experimental population will take two approaches,&#xD;
      the first being the use of functional Magnetic Resonance Imaging (fMRI) to assess the regions&#xD;
      of the brain that may become activated as a consequence of experiencing the cumulative&#xD;
      gardening activities and associated stimuli. The allied approach will employ widely used and&#xD;
      well-established self-reported assessment instruments that will capture information about the&#xD;
      health and well-being that will then provide a psychometrically-based before and after&#xD;
      physical and health summary of the participants in the control group and those engaged in the&#xD;
      gardening activities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this project is to better understand how interacting and working with plants in a&#xD;
      group gardening activities program that takes place in a greenhouse effects patterns of brain&#xD;
      activity and overall health and well-being. There has been essentially no assessment of the&#xD;
      effects of gardening or engaging in gardening activities on brain activity using functional&#xD;
      MRI (fMRI) approaches. This study will employ visual stimuli to assess the effects of the&#xD;
      gardening activities treatment on Blood Oxygen Level Dependent (BOLD) responses as revealed&#xD;
      by fMRI in study subjects in a comparison of responses before and after engaging in the&#xD;
      gardening intervention program.&#xD;
&#xD;
      Specifically this study seeks to determine whether engaging in gardening activities taking&#xD;
      place in a greenhouse can influence brain activity and function, and result in changes in&#xD;
      overall quality of life status of subjects in a wellness population.&#xD;
&#xD;
      The total study population (N = 23) will consist of 11 healthy women in the control group,&#xD;
      and 12 healthy women in the treatment group. There will be fMRI brain scans and psychometric&#xD;
      pre- and post-intervention assessments administered to the study subjects. The fMRI and&#xD;
      psychometric assessments will be administered within 10 days prior to the start of the&#xD;
      intervention, and within 10 days following the completion of the treatment intervention. The&#xD;
      control group will continue with normal daily life over a seven to eight week interval, and&#xD;
      receive no other intervention. The treatment group will be divided into two groups of six&#xD;
      women each that will receive the gardening intervention on different days of the week. The&#xD;
      participants in the treatment group will receive an experimental intervention consisting of&#xD;
      12 gardening sessions, each approximately 60 minutes in duration over a six week treatment&#xD;
      period. Each gardening session will take place at the same time of day twice each week, and&#xD;
      follow a standardized programming sequence to ensure equivalency of intervention across all&#xD;
      gardening sessions. Ambient environmental conditions in the greenhouse during the gardening&#xD;
      sessions will be monitored and recorded. The gardening activities will emphasize growing&#xD;
      plants from seeds, plant propagation techniques, transplanting, and plant-mediated taste,&#xD;
      visual, olfactory and touch sensory stimulation. All gardening sessions will begin with a&#xD;
      short educational module introducing the plants and gardening activities taking place during&#xD;
      each session. In addition to the pre- and post-intervention assessments, psychometric&#xD;
      assessments will be administered for depression and mood states at specific time points&#xD;
      during the gardening activities to the treatment group to evaluate any changes over time&#xD;
      resulting from the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Spatial Patterns of Brain Network Activation</measure>
    <time_frame>Baseline, up to 2 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Overall Health Status</measure>
    <time_frame>Baseline, up to 2 months</time_frame>
    <description>The SF-36 Health Survey assessment instrument (Ware and Sherbourne 1992; Hays et al 1993) will be used to evaluate eight scales that link to physical and mental health over a 4-week recall interval. This will reveal whether engaging in gardening activities will or will not result in changes in the overall health status based on instrument's physical and mental health subcomponent assessments of the gardening treatment group compared to the control group. The overall assessment scale for the SF-36 ranges from a low of 36 to a high of 400, with the U.S. norm being 314.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depressive Symptomatology</measure>
    <time_frame>Baseline, up to 2 months</time_frame>
    <description>The study protocol will use the Beck Depression Inventory 2nd edition (BDI-II) (Beck et al 1988) with a recall interval of 2-weeks to gain insight relative to the intensity of depression. This assessment will determine whether engaging in gardening will or will not result in changes in depressive symptomatology of the gardening treatment group relative to the control group. The assessment scale for the Beck BDI ranges from a low of 10 to a high of 63. Scores 0-13 indicate minimal depressive symptomatology and above 19 up to 63 moderate to severe depressive symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in State Anxiety</measure>
    <time_frame>Baseline up to 2 months</time_frame>
    <description>The State Trait Anxiety Inventory (STAI) instrument (Form Y) (Spielberger et al 1983) will be used in this study to gain insight regarding the relative intensity of anxiety being experienced by the gardening treatment group relative to the control group. The STAI reports on &quot;at this moment&quot; status. The STAI assessment will seek to determine whether engaging in gardening will or will not result in changes in State Anxiety status of the participants. The overall assessment scale for the STAI-Y ranges from a low of 20 to a high of 80, with higher scores indicating greater intensity of anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mood States</measure>
    <time_frame>Baseline, up to 2 months</time_frame>
    <description>The study protocol will employ the Profile of Mood States 2nd edition short form for adults instrument (POMS2-AS) with an immediate recall interval (McNair et al 1981; Shacham 1983) to gain insight of the relative to transient and fluctuating moods and enduring states of affect. The POMS2-AS will assess whether engaging in gardening activities will or will not result in changes in mood and enduring states of affect status of the gardening treatment group relative to the control group, both during and following the completion of the gardening activities treatment regimen. The assessment scale for the POMS2-AS ranges from 5 to a high of 100 per scale .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Perceived Stress</measure>
    <time_frame>Baseline, up to 2 months</time_frame>
    <description>The study will use the Perceived Stress Scale (PSS) (Cohen et al 1983) with a recall interval of 4-weeks to gain insight relative to the intensity of perceived stress. This assessment will determine whether engaging in gardening activities will or will not result in changes in the perceived stress levels of the gardening treatment group relative to the control group. The assessment scale for the Perceived Stress Scale ranges from a low of 0 to a high of 40, indicating higher stress at higher scores. The norm score for women is 13.7.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Stress</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gardening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gardening</intervention_name>
    <description>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.</description>
    <arm_group_label>Gardening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Functional Magnetic Resonance Imaging (fMRI)</intervention_name>
    <description>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.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Gardening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>psychometric assessments</intervention_name>
    <description>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.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Gardening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Premenopausal women&#xD;
&#xD;
          -  26 - 49 years of age&#xD;
&#xD;
          -  Not pregnant&#xD;
&#xD;
          -  Non-gardener&#xD;
&#xD;
          -  Non-smoker&#xD;
&#xD;
          -  Good Health&#xD;
&#xD;
          -  Able to participate in all aspects of the study, including working with plants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncomfortable in close spaces (claustrophobia)&#xD;
&#xD;
          -  Allergies to plants&#xD;
&#xD;
          -  Allergies to plant parts like pollen&#xD;
&#xD;
          -  Allergies to plant-based foods&#xD;
&#xD;
          -  No additions to alcohol or to recreational drugs or prescription medications&#xD;
&#xD;
          -  Not suffering from recurring pain, and&#xD;
&#xD;
          -  No diseases, disorders or disabilities that affect daily life.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>26 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles L Guy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fifield Hall</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McKnight Brain Institute</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilmot Greenhouse</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>1593914</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8275167</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>Spielberger, CD, Gorsuch RL, Lushene R. The State-Trait Personality Inventory STAI-Y, form Y. Consulting Psychologists Press, Palo Alto. 1983</citation>
  </reference>
  <reference>
    <citation>McNair PM, Lorr M, Droppleman LF. POMS manual (2nd ed.). San Diego: Educational and Industrial Testing Service. 1981.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>6886962</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>6668417</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>May 22, 2019</last_update_submitted>
  <last_update_submitted_qc>May 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gardening</keyword>
  <keyword>Therapeutic Horticulture</keyword>
  <keyword>Functional Magnetic Resonance Imaging</keyword>
  <keyword>Psychometric Assessment</keyword>
  <keyword>Stress</keyword>
  <keyword>Depression</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Wellness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>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/.&#xD;
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/.&#xD;
The URL for Neurosynth is: http://www.neurosynth.org/.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02225847
org study id: IRB201400425
nct id: NCT02225847
lead sponsor: 
collaborator: 
has dmc: No
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.
The goal of this project is to better understand how interacting and working with plants in a
      group gardening activities program that takes place in a greenhouse effects patterns of brain
      activity and overall health and well-being. There has been essentially no assessment of the
      effects of gardening or engaging in gardening activities on brain activity using functional
      MRI (fMRI) approaches. This study will employ visual stimuli to assess the effects of the
      gardening activities treatment on Blood Oxygen Level Dependent (BOLD) responses as revealed
      by fMRI in study subjects in a comparison of responses before and after engaging in the
      gardening intervention program.

      Specifically this study seeks to determine whether engaging in gardening activities taking
      place in a greenhouse can influence brain activity and function, and result in changes in
      overall quality of life status of subjects in a wellness population.

      The total study population (N = 23) will consist of 11 healthy women in the control group,
      and 12 healthy women in the treatment group. There will be fMRI brain scans and psychometric
      pre- and post-intervention assessments administered to the study subjects. The fMRI and
      psychometric assessments will be administered within 10 days prior to the start of the
      intervention, and within 10 days following the completion of the treatment intervention. The
      control group will continue with normal daily life over a seven to eight week interval, and
      receive no other intervention. The treatment group will be divided into two groups of six
      women each that will receive the gardening intervention on different days of the week. The
      participants in the treatment group will receive an experimental intervention consisting of
      12 gardening sessions, each approximately 60 minutes in duration over a six week treatment
      period. Each gardening session will take place at the same time of day twice each week, and
      follow a standardized programming sequence to ensure equivalency of intervention across all
      gardening sessions. Ambient environmental conditions in the greenhouse during the gardening
      sessions will be monitored and recorded. The gardening activities will emphasize growing
      plants from seeds, plant propagation techniques, transplanting, and plant-mediated taste,
      visual, olfactory and touch sensory stimulation. All gardening sessions will begin with a
      short educational module introducing the plants and gardening activities taking place during
      each session. In addition to the pre- and post-intervention assessments, psychometric
      assessments will be administered for depression and mood states at specific time points
      during the gardening activities to the treatment group to evaluate any changes over time
      resulting from the intervention.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in Spatial Patterns of Brain Network Activation
time frame: Baseline, up to 2 months
description: 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.
measure: Change in Overall Health Status
time frame: Baseline, up to 2 months
description: The SF-36 Health Survey assessment instrument (Ware and Sherbourne 1992; Hays et al 1993) will be used to evaluate eight scales that link to physical and mental health over a 4-week recall interval. This will reveal whether engaging in gardening activities will or will not result in changes in the overall health status based on instrument's physical and mental health subcomponent assessments of the gardening treatment group compared to the control group. The overall assessment scale for the SF-36 ranges from a low of 36 to a high of 400, with the U.S. norm being 314.
measure: Change in Depressive Symptomatology
time frame: Baseline, up to 2 months
description: The study protocol will use the Beck Depression Inventory 2nd edition (BDI-II) (Beck et al 1988) with a recall interval of 2-weeks to gain insight relative to the intensity of depression. This assessment will determine whether engaging in gardening will or will not result in changes in depressive symptomatology of the gardening treatment group relative to the control group. The assessment scale for the Beck BDI ranges from a low of 10 to a high of 63. Scores 0-13 indicate minimal depressive symptomatology and above 19 up to 63 moderate to severe depressive symptomatology.
measure: Change in State Anxiety
time frame: Baseline up to 2 months
description: The State Trait Anxiety Inventory (STAI) instrument (Form Y) (Spielberger et al 1983) will be used in this study to gain insight regarding the relative intensity of anxiety being experienced by the gardening treatment group relative to the control group. The STAI reports on "at this moment" status. The STAI assessment will seek to determine whether engaging in gardening will or will not result in changes in State Anxiety status of the participants. The overall assessment scale for the STAI-Y ranges from a low of 20 to a high of 80, with higher scores indicating greater intensity of anxiety.
measure: Change in Mood States
time frame: Baseline, up to 2 months
description: The study protocol will employ the Profile of Mood States 2nd edition short form for adults instrument (POMS2-AS) with an immediate recall interval (McNair et al 1981; Shacham 1983) to gain insight of the relative to transient and fluctuating moods and enduring states of affect. The POMS2-AS will assess whether engaging in gardening activities will or will not result in changes in mood and enduring states of affect status of the gardening treatment group relative to the control group, both during and following the completion of the gardening activities treatment regimen. The assessment scale for the POMS2-AS ranges from 5 to a high of 100 per scale .
measure: Change in Perceived Stress
time frame: Baseline, up to 2 months
description: The study will use the Perceived Stress Scale (PSS) (Cohen et al 1983) with a recall interval of 4-weeks to gain insight relative to the intensity of perceived stress. This assessment will determine whether engaging in gardening activities will or will not result in changes in the perceived stress levels of the gardening treatment group relative to the control group. The assessment scale for the Perceived Stress Scale ranges from a low of 0 to a high of 40, indicating higher stress at higher scores. The norm score for women is 13.7.
arm group label: Control
arm group type: Active Comparator
description: 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.
arm group label: Gardening
arm group type: Experimental
description: 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.
intervention type: Other
intervention name: Gardening
description: 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.
arm group label: Gardening
intervention type: Procedure
intervention name: Functional Magnetic Resonance Imaging (fMRI)
description: 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.
arm group label: Control
arm group label: Gardening
intervention type: Behavioral
intervention name: psychometric assessments
description: 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.
arm group label: Control
arm group label: Gardening
criteria: 
gender: Female
minimum age: 26 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Charles L Guy, PhD
role: Principal Investigator
affiliation: University of Florida
facility: 
facility: 
facility: 
country: United States
citation: 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: 1593914
citation: 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: 8275167
citation: 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.
citation: Spielberger, CD, Gorsuch RL, Lushene R. The State-Trait Personality Inventory STAI-Y, form Y. Consulting Psychologists Press, Palo Alto. 1983
citation: McNair PM, Lorr M, Droppleman LF. POMS manual (2nd ed.). San Diego: Educational and Industrial Testing Service. 1981.
citation: 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: 6886962
citation: 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: 6668417
responsible party type: Sponsor
mesh term: Depression
sharing ipd: Yes
ipd description: 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/.