An interventional study of Art and Gardening in Anxiety, Depression and Healthy, sponsored by University of Florida. Completed at 2 sites in United States. Open to female participants aged 26 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by University of Florida · Not applicable, Interventional, and Basic science
Among 13 studies in Depression by University of Florida — 3 open to participants now, 4 under way, 1 of them phase 3. Depression · University of Florida.
Among the 13 studies in Depression by University of Florida, this one is the 6th largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2017, is one of 9 with no phase, and was the 6th registered.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
Browse Depression studies →3 of the 13 studies in Depression by University of Florida are open now, in 1 country. Recruiting first, the newest first:
University of Florida · Sites in United States
University of Florida · Sites in United States
University of Florida · Sites in United States
By country, each count listing its studies:
Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.
This study: 26 Years to 49 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2017.
This study's enrollment of 36 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Median enrollment 47 across the 10 interventional studies, 71 across the 3 observational. Of the 8 that completed or were terminated, 2 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
1 of the studies in Depression by University of Florida that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07112001University of FloridaA Behavioral mHealth Intervention for People With HIV With Anxiety and Depression | 2026-11-30 |
Among the 13 studies in Depression by University of Florida, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 36 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Art
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.
Other: Gardening
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.
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.
Also known as: Horticulture, People-Plant Interactions
Biometric Changes in Heart Rate
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.
Time frame: Baseline, up to 5 weeks
Biometric Changes in Blood Pressure
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.
Time frame: Baseline, up to 5 weeks
Biometric Changes in Overall Health Status
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.
Time frame: Baseline, up to 5 weeks
Biometric Changes in Depressive Symptomatology
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.
Time frame: Baseline, up to 5 weeks
Biometric Changes in State Anxiety
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.
Time frame: Baseline, up to 5 weeks
Biometric Changes in Mood States
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 .
Time frame: Baseline, up to 5 weeks
Biometric Changes in Perceived Stress
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.
Time frame: Baseline, up to 5 weeks
Biometric Changes in Satisfaction in Social Activities
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)
Time frame: Baseline, up to 5 weeks
Plan to share: No
Ran from Aug 2017 to primary completion in Nov 2017, 3 months.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 3 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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