- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06950801
Comparing the Effects of Indoor vs. Outdoor Horticultural Therapy on College Students
This study used a randomised controlled trial to investigate the effects of different forms of horticultural group interventions on college students' depression, anxiety and subjective well-being, and the internal mechanisms of the effects.
Participants are required to complete the following tasks:
Attend one indoor/outdoor group gardening activity per week, lasting 2 hours each session, for a total of 8 weeks.
Complete psychological scale assessments at five time points: before the activity begins, at 4 weeks after the start, upon completion of the activity, and at 1 week and 2 weeks after completion.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Central University of Finance and Economics, Beijing, Beijing 100875
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- University students
Exclusion Criteria:
- Diagnosed with a mental disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: outdoor-horticultural
The participants in outdoor horticultural therapy engaged in weekly horticultural therapy activities outdoors for a total duration of eight weeks.
|
Students are randomly assigned to the Outdoor Horticultural Therapy group, where they will receive outdoor horticultural therapy for eight weeks
|
|
Experimental: indoor-Horticultural
The participants in indoor horticultural therapy engaged in therapeutic gardening activities indoors once a week for a total duration of eight weeks.
|
Students are randomly assigned to the indoor horticultural therapy group, where they will receive indoor horticultural therapy for 8 weeks
|
|
Placebo Comparator: General Psychological Group
Participants in the control group attended weekly psychological group sessions (without horticultural elements) for a total duration of eight weeks.
|
Students were randomly assigned to general group groups to participate in an 8-week mental health group activity
|
|
No Intervention: Blank control group
These participants did not engage in any psychological activities; they only regularly took part in questionnaire completion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: From enrollment to 2 weeks after the completion of the 8-week treatment Edit Copy Outcome
|
The Patient Health Questionnaire 9-item (PHQ-9): This scale consists of 9 items, each rated on a 4-point Likert scale, with higher scores indicating more severe depressive symptoms in the subject.
|
From enrollment to 2 weeks after the completion of the 8-week treatment Edit Copy Outcome
|
|
Anxiety
Time Frame: From enrollment to 2 weeks after the completion of the 8-week treatment
|
Generalized Anxiety Disorder 7-item Scale (GAD-7): This scale consists of 7 items, each rated on a 4-point Likert scale, with higher scores indicating more severe anxiety symptoms in the subjects.
|
From enrollment to 2 weeks after the completion of the 8-week treatment
|
|
Positive And Negative Affective
Time Frame: From enrollment to 2 weeks after the completion of the 8-week treatment
|
Positive and Negative Affect Schedule (PANAS): This scale consists of 20 items, including 10 positive affect items and 10 negative affect items, with each item rated on a Likert five-point scale.
Higher scores on the positive affect items indicate higher levels of positive affect in the participants, while higher scores on the negative affect items indicate higher levels of negative affect in the participants.
|
From enrollment to 2 weeks after the completion of the 8-week treatment
|
|
Life satisfaction
Time Frame: From enrollment to 2 weeks after the completion of the 8-week treatment
|
The Satisfaction With Life Scale (SWLS): This scale consists of 5 items, each rated on a 7-point Likert scale, with higher scores indicating greater life satisfaction among participants.
|
From enrollment to 2 weeks after the completion of the 8-week treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resilience
Time Frame: From enrollment to 2 weeks after the completion of the 8-week treatment
|
The Connor-Davidson Resilience Scale (CD-RISC): The scale consists of 25 items divided into three dimensions-tenacity, self-reliance, and optimism.
Each item is rated on a Likert five-point scale.
Higher scores indicate greater psychological resilience in the subjects.
|
From enrollment to 2 weeks after the completion of the 8-week treatment
|
|
Loneliness
Time Frame: From enrollment to 2 weeks after the completion of the 8-week treatment
|
UCLA Loneliness Scale: This scale consists of 8 items, each rated on a 5-point Likert scale, with higher scores indicating stronger feelings of loneliness in the subjects.
|
From enrollment to 2 weeks after the completion of the 8-week treatment
|
|
Sense of control
Time Frame: From enrollment to 2 weeks after the completion of the 8-week treatment
|
Sense of Mastery Scale (SMS): This scale consists of 7 items, each using a 5-point Likert scale, with higher scores indicating a stronger sense of mastery in the subjects.
|
From enrollment to 2 weeks after the completion of the 8-week treatment
|
|
Avoidance
Time Frame: From enrollment to 2 weeks after the completion of the 8-week treatment
|
The Brief Experiential Avoidance Questionnaire (BEAQ) was initially simplified and revised by Gámez et al. based on the Multidimensional Experiential Avoidance Questionnaire to assess content related to experiential avoidance.
Cao et al. conducted a Chinese version revision in 2021.
The questionnaire consists of 15 items, with the cognitive avoidance dimension containing 8 items and the behavioral avoidance dimension containing 7 items, all rated on a 6-point scale from "Strongly Disagree" to "Strongly Agree."
|
From enrollment to 2 weeks after the completion of the 8-week treatment
|
|
Self-concept
Time Frame: From enrollment to 2 weeks after the completion of the 8-week treatment
|
Sense of Mastery Scale, SMS.
This scale consists of 12 items, with each item rated on a five-point Likert scale.
Higher scores indicate a clearer self-concept among the participants.
|
From enrollment to 2 weeks after the completion of the 8-week treatment
|
|
meaning in life
Time Frame: From enrollment to 2 weeks after the completion of the 8-week treatment
|
The Meaning in Life Questionnaire (MLQ): This scale consists of 10 items with two dimensions: Presence of Meaning (MLQ-P) and Search for Meaning (MLQ-S).
Each item adopts a 7-point Likert scale, with higher scores indicating that participants experience a stronger sense of meaning in life.
|
From enrollment to 2 weeks after the completion of the 8-week treatment
|
|
Grit
Time Frame: From enrollment to 2 weeks after the completion of the 8-week treatment
|
The Grit Scale consists of 12 items with two dimensions: the Effort dimension and the Interest Consistency dimension.
Each item is rated on a five-point Likert scale, with higher scores indicating that participants perceive themselves as more perseverant.
|
From enrollment to 2 weeks after the completion of the 8-week treatment
|
|
nature connection
Time Frame: From enrollment to 2 weeks after the completion of the 8-week treatment
|
The Nature Connection Scale, which consists of 14 items, employs a 5-point Likert scale for each item, with higher scores indicating that participants perceive themselves as more closely connected to nature.
|
From enrollment to 2 weeks after the completion of the 8-week treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- cufe03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
PfizerNot yet recruitingHealthy | Healthy AdultsUnited States
-
Atisama TherapeuticsRecruitingHealthy | Healthy SmokerAustralia
Clinical Trials on outdoor-horticultural therapy
-
National Taipei University of Nursing and Health...RecruitingDepression | Stress | Happiness | Heart Rate VariabilityTaiwan
-
Khoo Teck Puat HospitalCompletedFrailty | HospitalismSingapore
-
Istanbul University - Cerrahpasa (IUC)UnknownElderly | Loneliness | Happiness | Horticultural TherapyTurkey
-
National University Hospital, SingaporeMinistry of Health, Singapore; Ministry of National Development, Singapore; National...UnknownDementia | Horticultural TherapySingapore
-
National University of SingaporeNational Parks Board, SingaporeUnknownMood (Psychological Function)Singapore
-
Ataturk UniversityActive, not recruitingHemodialysis PatientsTurkey (Türkiye)
-
Alexandria UniversityCompleted
-
The Hong Kong Polytechnic UniversityCompletedIntellectual Disability | Mental Disorders, SevereHong Kong
-
TsaoTun Psychiatric Center, Department of Health...RecruitingChronic SchizophreniaTaiwan
-
National Taiwan Normal UniversityCompletedMental Health | Physical HealthTaiwan