<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/NCT03266120</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201701647</org_study_id>
    <nct_id>NCT03266120</nct_id>
  </id_info>
  <brief_title>Health Benefits of Gardening</brief_title>
  <official_title>Assessing Human Health Benefits of Gardening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the research is to test the hypothesis that participating in group-based&#xD;
      gardening or group-based art activities may alter the mental health and cardiac physiological&#xD;
      status of a wellness population of women ages 26-49. Assessment of the effects of gardening&#xD;
      or art activities on the experimental population will take two approaches, the first being&#xD;
      the use of physiological measurements of heart rate and blood pressure. The second approach&#xD;
      will employ six widely used and well-established self-reported assessment instruments that&#xD;
      will capture information about the health and well-being of participants. These measurements&#xD;
      and assessments will provide a psychometrically-based before and after mental health status&#xD;
      and between treatments health summaries of the participants in the gardening group and those&#xD;
      engaged in the art group 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 in a greenhouse, or a group art program that takes place&#xD;
      indoors and is devoid of images or depictions of plants influences the overall health and&#xD;
      well-being of participants.&#xD;
&#xD;
      A total anticipated study population (N = 40) will consist of up to 20 healthy women randomly&#xD;
      assigned to the art activities group, and up to 20 healthy women assigned to the gardening&#xD;
      group. There will be measurements of heart rate, systolic and diastolic blood pressure, and&#xD;
      psychometric assessments including satisfaction of social activities at baseline and post&#xD;
      intervention. Heart rate and blood pressure measurements will be taken at the beginning and&#xD;
      end of each of the eight gardening or arts sessions. Psychometric assessments of study&#xD;
      participants will be conducted at baseline and post-intervention. Each treatment group will&#xD;
      be divided into two smaller groups of up to ten women each that will receive the gardening or&#xD;
      art interventions on different days of the week. The participants in the gardening or art&#xD;
      groups will receive an experimental intervention consisting of 8 gardening or art sessions,&#xD;
      each approximately 60 minutes in duration over a four week treatment period. Gardening and&#xD;
      art sessions will take place at the same time of day twice each week, and follow a&#xD;
      standardized programming sequence to ensure equivalency of intervention across all sessions.&#xD;
      Ambient environmental conditions in the greenhouse during the gardening sessions will be&#xD;
      monitored and recorded. The gardening activities will emphasize growing plants from seeds,&#xD;
      plant propagation techniques, transplanting, and plant-mediated taste, visual, olfactory and&#xD;
      touch sensory stimulation. All gardening sessions will begin with a short educational module&#xD;
      introducing the plants and gardening activities taking place during each session. Art&#xD;
      activities will include papermaking, image transfer, visual storytelling, linocut&#xD;
      printmaking, paper batik, mixed media collage, and sensation drawing, and begin with a short&#xD;
      educational module of the activity.&#xD;
&#xD;
      In addition to the pre- and post-intervention assessments and measurement, psychometric&#xD;
      assessments will be administered for depression symptomatology, mood states and perceived&#xD;
      stress at specific points during the gardening and art activities to evaluate any changes&#xD;
      over time resulting from the interventions. Participant heart rate and blood pressure&#xD;
      measurements will be made at the beginning and at the end of all gardening and art sessions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2017</start_date>
  <completion_date type="Actual">January 15, 2018</completion_date>
  <primary_completion_date type="Actual">November 9, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>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>Biometric Changes in Heart Rate</measure>
    <time_frame>Baseline, up to 5 weeks</time_frame>
    <description>Heart rate will be monitored using a portable electronic wrist cuff monitor. Participant heart rate will be measured at the beginning and end of each Individual treatment session, and before the beginning and after the completion of the entire treatment interventions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biometric Changes in Blood Pressure</measure>
    <time_frame>Baseline, up to 5 weeks</time_frame>
    <description>Blood pressure will be monitored using a portable electronic wrist cuff blood pressure monitor that records systolic and diastolic pressure. Participant blood pressure measurements will be recorded before and after each individual treatment session, and before the beginning and after the completion of the entire treatment interventions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biometric Changes in Overall Health Status</measure>
    <time_frame>Baseline, up to 5 weeks</time_frame>
    <description>The SF-36v2 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>Biometric Changes in Depressive Symptomatology</measure>
    <time_frame>Baseline, up to 5 weeks</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>Biometric Changes in State Anxiety</measure>
    <time_frame>Baseline, up to 5 weeks</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>Biometric Changes in Mood States</measure>
    <time_frame>Baseline, up to 5 weeks</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>Biometric Changes in Perceived Stress</measure>
    <time_frame>Baseline, up to 5 weeks</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>
  <secondary_outcome>
    <measure>Biometric Changes in Satisfaction in Social Activities</measure>
    <time_frame>Baseline, up to 5 weeks</time_frame>
    <description>The study will use the The Satisfaction with Participation in Discretionary Social Activities (SPDSA) PROMIS short form v1.0 instrument to assess contentment with participants' leisure time and affairs with friends, and encompasses a recall interval of one week (Hahn et al 2010)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <condition>Healthy</condition>
  <condition>Mood Disturbance</condition>
  <condition>Stress</condition>
  <condition>Quality of Life</condition>
  <condition>Physical Activity</condition>
  <condition>Social Interaction</condition>
  <arm_group>
    <arm_group_label>Art Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomly assigned to this arm will receive a hands-on art intervention that will consist of twice weekly group sessions of approximately 60 minutes each in duration that will take place indoors over a period of four weeks for a total of eight art sessions. Participants will complete sets of self-report psychometric assessments and blood pressure and heart rate will be monitored before, during, and following the conclusion of the intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gardening Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomly assigned to this arm will receive a hands-on gardening intervention that will consist of twice weekly group sessions of approximately 60 minutes each in duration that will take place in a greenhouse over a period of four weeks for a total of eight gardening sessions. Participants will complete sets of self-report psychometric assessments and blood pressure and heart rate will be monitored before, during, and following the conclusion of the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Art</intervention_name>
    <description>Participants will receive a hands-on art activities intervention consisting of two art activities sessions each week lasting approximately 60 minutes each in duration for four weeks for a total of eight sessions. Art activities will include hand papermaking, image transfer, visual storytelling, linocut printmaking, paper batik, mixed media collage, and sensation drawing based activities. Participants will complete sets of self-report psychometric assessments before, during, and following the art intervention. Heart rate and blood pressure will be monitored before, during, and following completion of the art intervention.</description>
    <arm_group_label>Art Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gardening</intervention_name>
    <description>Participants will receive a hands-on gardening intervention consisting of two gardening sessions each week lasting approximately 60 minutes each in duration for four weeks, for a total of eight sessions. Gardening activities will include planting seeds, bulbs and tubers, transplanting seedlings, vegetative propagation and sight, smell, taste and touch sensory based activities. Participants will complete sets of self-report psychometric assessments before, during, and following the gardening intervention. Heart rate and blood pressure will be monitored before, during, and following completion of the gardening intervention.</description>
    <arm_group_label>Gardening Intervention</arm_group_label>
    <other_name>Horticulture</other_name>
    <other_name>People-Plant Interactions</other_name>
  </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-artist&#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 and Merhof Halls</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilmot Gardens Conference Center and 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>
  <reference>
    <citation>Hahn EA, Beaumont JL, Pilkonis PA, Garcia SF, Magasi S, DeWalt DA, Cella D. The PROMIS satisfaction with social participation measures demonstrated responsiveness in diverse clinical populations. J Clin Epidemiol. 2016 May;73:135-41. doi: 10.1016/j.jclinepi.2015.08.034. Epub 2016 Feb 27.</citation>
    <PMID>26931288</PMID>
  </reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>June 4, 2018</last_update_submitted>
  <last_update_submitted_qc>June 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gardening</keyword>
  <keyword>Therapeutic Arts</keyword>
  <keyword>Therapeutic Horticulture</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Depression</keyword>
  <keyword>Mood States</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Social Interactions</keyword>
  <keyword>Stress</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>No</sharing_ipd>
  </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/NCT03266120
org study id: IRB201701647
nct id: NCT03266120
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the research is to test the hypothesis that participating in group-based
      gardening or group-based art activities may alter the mental health and cardiac physiological
      status of a wellness population of women ages 26-49. Assessment of the effects of gardening
      or art activities on the experimental population will take two approaches, the first being
      the use of physiological measurements of heart rate and blood pressure. The second approach
      will employ six widely used and well-established self-reported assessment instruments that
      will capture information about the health and well-being of participants. These measurements
      and assessments will provide a psychometrically-based before and after mental health status
      and between treatments health summaries of the participants in the gardening group and those
      engaged in the art group activities.
The goal of this project is to better understand how interacting and working with plants in a
      group gardening activities program in a greenhouse, or a group art program that takes place
      indoors and is devoid of images or depictions of plants influences the overall health and
      well-being of participants.

      A total anticipated study population (N = 40) will consist of up to 20 healthy women randomly
      assigned to the art activities group, and up to 20 healthy women assigned to the gardening
      group. There will be measurements of heart rate, systolic and diastolic blood pressure, and
      psychometric assessments including satisfaction of social activities at baseline and post
      intervention. Heart rate and blood pressure measurements will be taken at the beginning and
      end of each of the eight gardening or arts sessions. Psychometric assessments of study
      participants will be conducted at baseline and post-intervention. Each treatment group will
      be divided into two smaller groups of up to ten women each that will receive the gardening or
      art interventions on different days of the week. The participants in the gardening or art
      groups will receive an experimental intervention consisting of 8 gardening or art sessions,
      each approximately 60 minutes in duration over a four week treatment period. Gardening and
      art sessions 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 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. Art
      activities will include papermaking, image transfer, visual storytelling, linocut
      printmaking, paper batik, mixed media collage, and sensation drawing, and begin with a short
      educational module of the activity.

      In addition to the pre- and post-intervention assessments and measurement, psychometric
      assessments will be administered for depression symptomatology, mood states and perceived
      stress at specific points during the gardening and art activities to evaluate any changes
      over time resulting from the interventions. Participant heart rate and blood pressure
      measurements will be made at the beginning and at the end of all gardening and art sessions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Biometric Changes in Heart Rate
time frame: Baseline, up to 5 weeks
description: Heart rate will be monitored using a portable electronic wrist cuff monitor. Participant heart rate will be measured at the beginning and end of each Individual treatment session, and before the beginning and after the completion of the entire treatment interventions.
measure: Biometric Changes in Blood Pressure
time frame: Baseline, up to 5 weeks
description: Blood pressure will be monitored using a portable electronic wrist cuff blood pressure monitor that records systolic and diastolic pressure. Participant blood pressure measurements will be recorded before and after each individual treatment session, and before the beginning and after the completion of the entire treatment interventions.
measure: Biometric Changes in Overall Health Status
time frame: Baseline, up to 5 weeks
description: The SF-36v2 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: Biometric Changes in Depressive Symptomatology
time frame: Baseline, up to 5 weeks
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: Biometric Changes in State Anxiety
time frame: Baseline, up to 5 weeks
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: Biometric Changes in Mood States
time frame: Baseline, up to 5 weeks
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: Biometric Changes in Perceived Stress
time frame: Baseline, up to 5 weeks
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.
measure: Biometric Changes in Satisfaction in Social Activities
time frame: Baseline, up to 5 weeks
description: The study will use the The Satisfaction with Participation in Discretionary Social Activities (SPDSA) PROMIS short form v1.0 instrument to assess contentment with participants' leisure time and affairs with friends, and encompasses a recall interval of one week (Hahn et al 2010)
arm group label: Art Intervention
arm group type: Active Comparator
description: Participants randomly assigned to this arm will receive a hands-on art intervention that will consist of twice weekly group sessions of approximately 60 minutes each in duration that will take place indoors over a period of four weeks for a total of eight art sessions. Participants will complete sets of self-report psychometric assessments and blood pressure and heart rate will be monitored before, during, and following the conclusion of the intervention.
arm group label: Gardening Intervention
arm group type: Experimental
description: Participants randomly assigned to this arm will receive a hands-on gardening intervention that will consist of twice weekly group sessions of approximately 60 minutes each in duration that will take place in a greenhouse over a period of four weeks for a total of eight gardening sessions. Participants will complete sets of self-report psychometric assessments and blood pressure and heart rate will be monitored before, during, and following the conclusion of the intervention.
intervention type: Other
intervention name: Art
description: Participants will receive a hands-on art activities intervention consisting of two art activities sessions each week lasting approximately 60 minutes each in duration for four weeks for a total of eight sessions. Art activities will include hand papermaking, image transfer, visual storytelling, linocut printmaking, paper batik, mixed media collage, and sensation drawing based activities. Participants will complete sets of self-report psychometric assessments before, during, and following the art intervention. Heart rate and blood pressure will be monitored before, during, and following completion of the art intervention.
arm group label: Art Intervention
intervention type: Other
intervention name: Gardening
description: Participants will receive a hands-on gardening intervention consisting of two gardening sessions each week lasting approximately 60 minutes each in duration for four weeks, for a total of eight sessions. Gardening activities will include planting seeds, bulbs and tubers, transplanting seedlings, vegetative propagation and sight, smell, taste and touch sensory based activities. Participants will complete sets of self-report psychometric assessments before, during, and following the gardening intervention. Heart rate and blood pressure will be monitored before, during, and following completion of the gardening intervention.
arm group label: Gardening Intervention
other name: Horticulture
other name: People-Plant Interactions
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: 
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
citation: Hahn EA, Beaumont JL, Pilkonis PA, Garcia SF, Magasi S, DeWalt DA, Cella D. The PROMIS satisfaction with social participation measures demonstrated responsiveness in diverse clinical populations. J Clin Epidemiol. 2016 May;73:135-41. doi: 10.1016/j.jclinepi.2015.08.034. Epub 2016 Feb 27.
PMID: 26931288
responsible party type: Sponsor
mesh term: Depression
sharing ipd: No