DepressionNCT07115381
A Study on the Intervention Effect of Therapeutic Horticulture Based on the Healing System on Non-suicidal Self-injury in Adolescent Patients With Depression
A study testing Therapeutic Horticulture and Routine treatment and nursing in people with Depression, run by Lei Huang at 1 site in China.
Trial summary
Non-suicidal self-harm is a serious issue. Adolescents with depression are among the high-risk groups for non-suicidal self-harm behavior. Therapeutic gardening uses plant cultivation and corresponding gardening activities as the medium of action, allowing patients to obtain therapeutic benefits by participating in… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depression
- What is being tested?
- Therapeutic Horticulture and Routine treatment and nursing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- Feb 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- It meets the diagnostic criteria for moderate to severe depression in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- It meets the diagnostic criteria for non-suicidal self-harm in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- The patients and their guardians gave informed consent and voluntarily participated in this study.
- Have normal reading comprehension ability, language communication ability and writing ability.
Who cannot join
- Include mental disorders such as mental retardation, autism spectrum disorder, stereotyped movement disorder with self-harm, etc.
- Have had or currently have central nervous system diseases, endocrine system diseases, and other serious physical disorders.
- Are currently receiving or have received any form of systematic horticultural therapy within the past 3 months.
- Have allergic reactions to pollen, soil, or other substances that may be encountered during the intervention process.
- Have a risk of suicide and suicidal behavior.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Affiliated Brain Hospital, Guangzhou Medical University
Guangzhou
Zhichun Xia, bachelor degree, 0086-13416275948, xzcloke@aliyun.com
About this study
Non-suicidal self-harm is a serious issue. Adolescents with depression are among the high-risk groups for non-suicidal self-harm behavior. Therapeutic gardening uses plant cultivation and corresponding gardening activities as the medium of action, allowing patients to obtain therapeutic benefits by participating in gardening activities such as planting, maintaining, and harvesting plants. Therefore, this study will apply therapeutic gardening based on the healing system to adolescents with depression who have non-suicidal self-harm behavior, in order to improve their non-suicidal self-harm behavior, negative emotions, emotional expression disorders, self-efficacy, sleep quality, and loneliness.
Read the detailed description
Based on the theories of positive psychology and the healing system theory framework, referring to relevant domestic and foreign literature and consulting books such as "Introduction to Horticultural Therapy", "Horticultural Rehabilitation Therapy Techniques", and "Horticultural Therapy: Growing Good Health for the Body and Mind", an intervention plan was formulated under the guidance of experts. A randomized controlled trial design was adopted. It is planned to carry out therapeutic horticulture based on the healing system for adolescent patients with depression who have non-suicidal self-harming behaviors, according to the intervention plan. By evaluating and comparing the changes and differences in indicators such as non-suicidal self-harming behaviors, emotions, physical functions, skills, and social interaction of the experimental group and the control group before and after the intervention, the actual effect of therapeutic horticulture based on the healing system in reducing the occurrence of non-suicidal self-harming behaviors among adolescent patients was verified. Finally, data analysis and paper writing were conducted.
- Conditions
- Depression
- Being tested
- Therapeutic Horticulture, Routine treatment and nursing
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic HorticultureBehavioural
Therapeutic Horticulture uses plant cultivation and related gardening activities as the medium of action, allowing patients to participate in gardening activities such as planting, maintenance, and harvesting of plants.
Routine treatment and nursingOther
The conventional treatment mainly involves the use of antidepressant drugs, supplemented by physical therapy, psychological therapy, and rehabilitation training, etc. The routine care includes admission introduction, health education (manifestations, hazards, treatment methods of depression and non-suicidal self-harm, as well as the importance of following medical advice for treatment), medication guidance, discharge guidance, and psychological care, etc.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Routine treatment and nursing Receives: Other: Routine treatment and nursing |
| Therapeutic Horticulture group | Experimental | Routine treatment and nursing and Therapeutic Horticulture Receives: Behavioral: Therapeutic Horticulture; Other: Routine treatment and nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level and frequency of non-suicidal self-injury
The adolescent self-harm questionnaire was used to measure.This questionnaire is a self-assessment form, consisting of 19 items. Among them, the frequency of non-suicidal self-injury behavior is scored using the Likert 4-point scale: "0 times" is scored 0 points, "1 time" is scored 1 point, "2-4 times" is scored 2 points, and "5 times or more" is scored 3 points. The degree of physical harm caused is scored using the Likert 5-point scale: "No" is scored 0 points, "Mild" is scored 1 point, "Moderate" is scored 2 points, "Severe" is scored 3 points, and "Extremely severe" is scored 4 points. NSSI equivalence is equal to the product of the NSSI frequency score and the NSSI severity score. The higher the score, the more severe the condition.
Measured: Day 1 and Day 14
Secondary outcomes (5)
depressive symptom
Hamilton Depression Rating Scale-17 was used to measure.There are a total of 17 items. The lowest score of the Hamilton Depression Scale - 17 items (HAMD-17) is 0, and the highest score is 52. A total score of ≥ 24 may indicate severe depression; a score of 17 ≤ total score < 24 may indicate mild or moderate depression; a total score of ≤ 7 may indicate no depression. The higher the score, the more severe the depressive symptoms.
Measured: Day 1 and Day 14
sleep quality
The Pittsburgh Sleep Quality Index was used to measure.This scale is used to assess an individual's recent sleep quality. It consists of 19 self-assessment items and 5 other-rater items. The 19th self-assessment item and the 5 other-rater items do not contribute to the scoring. The first 18 items cover subjective sleep quality, sleep onset time, sleep duration, sleep efficiency, sleep disorders, hypnotic drugs, and daytime functional impairment. Each factor is scored on a scale of 0 to 3, and the total score of all factors is the PSQI total score. The total score ranges from 0 to 21, and a higher PSQI total score indicates poorer sleep quality.
Measured: Day 1 and Day 14
alexithymia
The Toronto Alexithymia Scale was used to measure.The scale consists of 20 items, including three factors: inability to identify emotions, inability to describe emotions, and extroverted thinking. It uses a 5-point scale from 1 (completely disagree) to 5 (completely agree), with a total score range of 20 to 100. The higher the score, the more severe the alexithymia is.
Measured: Day 1 and Day 14
loneliness
The UCLA loneliness Scale was used to measure.This scale is used to assess an individual's level of loneliness, consisting of 20 items, with a 4-point rating scale ranging from 1 to 4. Some of the items are reverse-scored. The total score is the sum of the scores of each item. The total score ranges from 20 to 80, with a higher total score indicating a stronger sense of loneliness.
Measured: Day 1 and Day 14
self-efficacy
The general self-efficacy scale was used to measure.This scale consists of 10 items. It uses a 4-point rating system, where "completely incorrect" is scored as 1 point, "somewhat correct" as 2 points, "mostly correct" as 3 points, and "completely correct" as 4 points. The highest score is 40 points and the lowest score is 10 points. The higher the score, the higher the level of self-efficacy.
Measured: Day 1 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study startFeb 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Huang, Guangzhou Medical University
- Investigators
- Zhichun Xia, Study director, The Affiliated Brain Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115381
- Sponsor's protocol ID
- (2025) No. (015)
- Status last verified
- Dec 2025
- First submitted
- 4 Aug 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang L, Hong TD, Liang SC, Huang ZJ, Liang YX, Shen LF, Xia ZC. The effect of therapeutic horticulture on non-suicidal self-injury in adolescents with major depressive disorder: protocol for a randomized controlled trial. Front Psychiatry. 2026 Jun 4;17:1790759. doi: 10.3389/fpsyt.2026.1790759. eCollection 2026.
PubMed 42325965
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Intervention Effect of Therapeutic Horticulture Based on the Healing System on Non-suicidal Self-injury in Adolescent Patients With Depression
- ClinicalTrials.gov ID
- NCT07115381
- Acronym / sponsor ID
- (2025) No. (015)
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Lei HuangUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Aug 2025 (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.
Non-suicidal self-harm is a serious issue. Adolescents with depression are among the high-risk groups for non-suicidal self-harm behavior. Therapeutic gardening uses plant cultivation and corresponding gardening activities as the medium of action, allowing patients to obtain therapeutic benefits by participating in gardening activities such as planting, maintaining, and harvesting plants. Therefore, this study will apply therapeutic gardening based on the healing system to adolescents with depression who have non-suicidal self-harm behavior, in order to improve their non-suicidal self-harm behavior, negative emotions, emotional expression disorders, self-efficacy, sleep quality, and loneliness.
Detailed description
Based on the theories of positive psychology and the healing system theory framework, referring to relevant domestic and foreign literature and consulting books such as "Introduction to Horticultural Therapy", "Horticultural Rehabilitation Therapy Techniques", and "Horticultural Therapy: Growing Good Health for the Body and Mind", an intervention plan was formulated under the guidance of experts. A randomized controlled trial design was adopted. It is planned to carry out therapeutic horticulture based on the healing system for adolescent patients with depression who have non-suicidal self-harming behaviors, according to the intervention plan. By evaluating and comparing the changes and differences in indicators such as non-suicidal self-harming behaviors, emotions, physical functions, skills, and social interaction of the experimental group and the control group before and after the intervention, the actual effect of therapeutic horticulture based on the healing system in reducing the occurrence of non-suicidal self-harming behaviors among adolescent patients was verified. Finally, data analysis and paper writing were conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Routine treatment and nursingRoutine treatment and nursing |
| Therapeutic Horticulture group | Experimental | Behavioral: Therapeutic Horticulture, Other: Routine treatment and nursingRoutine treatment and nursing and Therapeutic Horticulture |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- It meets the diagnostic criteria for moderate to severe depression in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- It meets the diagnostic criteria for non-suicidal self-harm in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- The patients and their guardians gave informed consent and voluntarily participated in this study.
- Have normal reading comprehension ability, language communication ability and writing ability.
Key exclusion criteria (5 listed)
- Include mental disorders such as mental retardation, autism spectrum disorder, stereotyped movement disorder with self-harm, etc.
- Have had or currently have central nervous system diseases, endocrine system diseases, and other serious physical disorders.
- Are currently receiving or have received any form of systematic horticultural therapy within the past 3 months.
- Have allergic reactions to pollen, soil, or other substances that may be encountered during the intervention process.
- Have a risk of suicide and suicidal behavior.
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 |
|---|---|---|
| Therapeutic HorticultureTherapeutic Horticulture uses plant cultivation and related gardening activities as the medium of action, allowing patients to participate in gardening activities such as planting, maintenance, and harvesting of plants. | Behavioural | Therapeutic Horticulture group |
| Routine treatment and nursingThe conventional treatment mainly involves the use of antidepressant drugs, supplemented by physical therapy, psychological therapy, and rehabilitation training, etc. The routine care includes admission introduction, health education (manifestations, hazards, treatment methods of depression and non-suicidal self-harm, as well as the importance of following medical advice for treatment), medication guidance, discharge guidance, and psychological care, etc. | Other | Control group, Therapeutic Horticulture group |
Primary outcome
The level and frequency of non-suicidal self-injury
Time frame: Day 1 and Day 14
The adolescent self-harm questionnaire was used to measure.This questionnaire is a self-assessment form, consisting of 19 items. Among them, the frequency of non-suicidal self-injury behavior is scored using the Likert 4-point scale: "0 times" is scored 0 points, "1 time" is scored 1 point, "2-4 times" is scored 2 points, and "5 times or more" is scored 3 points. The degree of physical harm caused is scored using the Likert 5-point scale: "No" is scored 0 points, "Mild" is scored 1 point, "Moderate" is scored 2 points, "Severe" is scored 3 points, and "Extremely severe" is scored 4 points. NSSI equivalence is equal to the product of the NSSI frequency score and the NSSI severity score. The higher the score, the more severe the condition.
5 secondary outcomes
depressive symptom
Time frame: Day 1 and Day 14
sleep quality
Time frame: Day 1 and Day 14
alexithymia
Time frame: Day 1 and Day 14
loneliness
Time frame: Day 1 and Day 14
self-efficacy
Time frame: Day 1 and Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Derived from this study: PubMed 42325965Huang L, Hong TD, Liang SC, Huang ZJ, Liang YX, Shen LF, Xia ZC. The effect of therapeutic horticulture on non-suicidal self-injury in adolescents with major depressive disorder: protocol for a randomized controlled trial. Front Psychiatry. 2026 Jun 4;17:1790759. doi: 10.3389/fpsyt.2026.1790759. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
Zhichun Xia study director
The Affiliated Brain Hospital of Guangzhou Medical 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 Therapeutic Horticulture and Routine treatment and nursing in people with Depression, run by Lei Huang at 1 site in China.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 30 Dec 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Huang, bachelor degree (0086-13660135023, huanglei8126@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level and frequency of non-suicidal self-injury (time frame: Day 1 and Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07115381, which also lists 1 linked publication.
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 30 Dec 2025.