Mental Disorders, SevereNCT04917666
Process and Outcomes of Horticultural Therapy for People With Disabilities
A study testing Horticultural therapy and Comparison in people with Mental Disorders, Severe and Intellectual Disability, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Horticultural therapy (HT) "is the engagement of a client in horticulture activities facilitated by a trained therapist to achieve specific and documented treatment goals" (American Horticultural Therapy Association, 2012). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Disorders, Severe, Intellectual Disability
- What is being tested?
- Horticultural therapy and Comparison
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2019to 29 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of severe mental disorder, e.g. schizophrenia, schizoaffective disorder, bipolar disorder.
- age 18 - 65.
- care home resident
Who cannot join
- organic brain disorder
- difficulties in communication for joining horticultural activity.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Tung Wah Group of Hospitals Wong Chuk Hang Complex
Wong Chuk Hang
About this study
Official title: Examining the Process and Outcomes of Horticultural Therapy for People With Severe Mental Illness, Intellectual, and Multiple Disabilities
Horticultural therapy (HT) "is the engagement of a client in horticulture activities facilitated by a trained therapist to achieve specific and documented treatment goals" (American Horticultural Therapy Association, 2012). People's interactions with plants, through goal-orientated horticultural activities in the form of active gardening, as well as the passive appreciation of nature, could be therapeutic to people with mental or intellectual disabilities in many ways (Eling, 2006; Parkinson, Lowe, \& Vecsey, 2011). This study aims to conduct evaluation studies of HT group programmes for care home residents with severe mental illness.
Read the detailed description
This is a randomized, single-blind, controlled study in which the outcomes of the horticultural therapy program is compared with a comparison group. Outcome measures were compared at Pre-intervention and post-intervention.
- Conditions
- Mental Disorders, Severe, Intellectual Disability
- Being tested
- Horticultural therapy, Comparison
- Keywords
- horticultural therapy, severe mental illness, care home residents
- Medical subject headings
- Mental Disorders, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horticultural therapyBehavioural
A structured 8-session group therapy program, in which participants learn about plants, green spaces, plant-human interactions. During the program, the participants are guided by therapist to grow or take care of both indoor and outdoor plants, do small horticulture projects (like cooking, making drinks, herb projects).
ComparisonOther
4 session of semi-structured and free engagement in activities of their choice. The activities that they could choose are mostly table-top activities which are solitary in nature, and does not require social interaction.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants joined a 8-session horticultural therapy group program (60 minutes per session) over 8 weeks. Receives: Behavioral: Horticultural therapy |
| Comparison | Other | Participants joined 4 sessions of individual, parallel, and table-top activities of their own interest, e.g. reading, drawing, coloring. Receives: Other: Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mental Well-being
Chinese Short Warwick-Edinburgh Mental Well-being Scale (C-SWEMWBS). The C-SWEMWBS uses a five-point Likert scale. The average scores for the scale ranges between 1 and 5, and a higher score indicates better mental well-being.
Measured: Pre-test, Postest (8 weeks from pre-test), Change from Pretest to Posttest is assessed
Change in Engagement in Meaningful Activity Scale (EMAS)
Engagement in Meaningful Activity Scale (EMAS). The EMAS has 12 items measured on a four-point Likert scale. The average score for the scale is 1- 4 and a higher score indicates higher engagement.
Measured: Pre-test, Postest (8 weeks from pre-test), Change from Pretest to Posttest is assessed
Change in Perceived Benefits of Horticultural Therapy
This is a opinion survey developed by the clinical setting to collect participants' attitude toward horticultural therapy. It has 7 items and participants are asked to respond using a five-point scale ranging from "strongly disagree" to "strongly agree". The average score ranges from 1 to 5, and a higher score indicates that the participant perceived the benefits of horticulture therapy as higher.
Measured: Pre-test, Postest (8 weeks from pre-test), Change from Pretest to Posttest is assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start1 Sep 2019
- Primary completion30 Sep 2020
- Study completion29 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Disorders, SevereStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew MH Siu, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917666
- Sponsor's protocol ID
- HSEARS20191030004
- Status last verified
- Mar 2021
- First submitted
- 1 Apr 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Process and Outcomes of Horticultural Therapy for People With Severe Mental Illness, Intellectual, and Multiple Disabilities
- ClinicalTrials.gov ID
- NCT04917666
- Acronym / sponsor ID
- HSEARS20191030004
- Conditions
- Mental Disorders, Severe, Intellectual Disability
- Keywords
- horticultural therapy, severe mental illness, care home residents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Horticultural therapy (HT) "is the engagement of a client in horticulture activities facilitated by a trained therapist to achieve specific and documented treatment goals" (American Horticultural Therapy Association, 2012). People's interactions with plants, through goal-orientated horticultural activities in the form of active gardening, as well as the passive appreciation of nature, could be therapeutic to people with mental or intellectual disabilities in many ways (Eling, 2006; Parkinson, Lowe, \& Vecsey, 2011). This study aims to conduct evaluation studies of HT group programmes for care home residents with severe mental illness.
Detailed description
This is a randomized, single-blind, controlled study in which the outcomes of the horticultural therapy program is compared with a comparison group. Outcome measures were compared at Pre-intervention and post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Horticultural therapyParticipants joined a 8-session horticultural therapy group program (60 minutes per session) over 8 weeks. |
| Comparison | Other | Other: ComparisonParticipants joined 4 sessions of individual, parallel, and table-top activities of their own interest, e.g. reading, drawing, coloring. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of severe mental disorder, e.g. schizophrenia, schizoaffective disorder, bipolar disorder.
- age 18 - 65.
- care home resident
Key exclusion criteria (2 listed)
- organic brain disorder
- difficulties in communication for joining horticultural activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Horticultural therapyA structured 8-session group therapy program, in which participants learn about plants, green spaces, plant-human interactions. During the program, the participants are guided by therapist to grow or take care of both indoor and outdoor plants, do small horticulture projects (like cooking, making drinks, herb projects). | Behavioural | Treatment |
| Comparison4 session of semi-structured and free engagement in activities of their choice. The activities that they could choose are mostly table-top activities which are solitary in nature, and does not require social interaction. | Other | Comparison |
Primary outcome
Change in Mental Well-being
Time frame: Pre-test, Postest (8 weeks from pre-test), Change from Pretest to Posttest is assessed
Chinese Short Warwick-Edinburgh Mental Well-being Scale (C-SWEMWBS). The C-SWEMWBS uses a five-point Likert scale. The average scores for the scale ranges between 1 and 5, and a higher score indicates better mental well-being.
Change in Engagement in Meaningful Activity Scale (EMAS)
Time frame: Pre-test, Postest (8 weeks from pre-test), Change from Pretest to Posttest is assessed
Engagement in Meaningful Activity Scale (EMAS). The EMAS has 12 items measured on a four-point Likert scale. The average score for the scale is 1- 4 and a higher score indicates higher engagement.
Change in Perceived Benefits of Horticultural Therapy
Time frame: Pre-test, Postest (8 weeks from pre-test), Change from Pretest to Posttest is assessed
This is a opinion survey developed by the clinical setting to collect participants' attitude toward horticultural therapy. It has 7 items and participants are asked to respond using a five-point scale ranging from "strongly disagree" to "strongly agree". The average score ranges from 1 to 5, and a higher score indicates that the participant perceived the benefits of horticulture therapy as higher.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew MH Siu, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Horticultural therapy and Comparison in people with Mental Disorders, Severe and Intellectual Disability, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mental Well-being (time frame: Pre-test, Postest (8 weeks from pre-test), Change from Pretest to Posttest is assessed). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.