AzTrials
AzTrials

Subthreshold DepressionNCT07275034

Effects of Virtual Reality-Based Horticultural Intervention for Older Adults With Subthreshold Depression in Nursing Homes

A study testing Virtual Reality-Based Horticultural Intervention System and routine health management in people with Subthreshold Depression, run by Fujian Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Subthreshold depression represents a state of psychological sub-health between normal individuals and clinical depression. It constitutes a high-risk stage for developing clinical depression and a critical phase for alleviating depressive symptoms. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Subthreshold Depression
What is being tested?
Virtual Reality-Based Horticultural Intervention System and routine health management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteChina
Study dates
10 Nov 2025to 16 Jan 2026
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • age ≥ 60 years;
  • meeting the diagnostic threshold for StD27, defined as a score ≥ 16 on the Center for Epidemiologic Studies Depression Scale (CES-D);
  • adequate visual, auditory, and verbal communication capacity;
  • provision of written informed consent.

Who cannot join

  • recent exposure to major traumatic events or current suicide risk;
  • concurrent participation in other similar studies;
  • not currently undergoing psychotherapy;
  • current use of antidepressant pharmacotherapy;
  • absence of severe cognitive impairment with a Montreal Cognitive Assessment (MoCA) score of >10;
  • severe physical comorbidities with a Activity of daily living (ADL) score of >29 ;
  • organic disorders resulting in functional self-care deficits.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Nursing school of Fujian Medical university

    Fujian, Fuzhou, 350001

Other trials in China

About this study

Official title: Effects of Virtual Reality-Based Horticultural Intervention for Older Adults With Subthreshold Depression in Nursing Homes: Randomized Controlled Trial

Subthreshold depression represents a state of psychological sub-health between normal individuals and clinical depression. It constitutes a high-risk stage for developing clinical depression and a critical phase for alleviating depressive symptoms. However, current research predominantly focuses on treating depression in the elderly, with insufficient attention to interventions for high-risk populations or limited to cross-sectional investigations of subthreshold depression risk factors. Therefore, prioritizing subthreshold depression in the elderly and implementing early interventions is essential. A 2024 article in The Lancet suggests that subthreshold depression treatment should prioritize psychotherapy and lifestyle adjustments over medication. Horticultural therapy, an interdisciplinary approach integrating horticulture, medicine, and psychology, demonstrates unique advantages over traditional medical treatments. In practical application, however, limited resources may hinder adequate support for horticultural activities, compromising activity quality, reducing therapeutic efficacy, and restricting the widespread adoption of horticultural therapy. Integrating VR technology with horticultural therapy can provide patients with more comprehensive, personalized, and effective mental health treatment plans, empowering them toward healthier, more positive lives. Therefore, the research team designed a VR horticultural intervention system for elderly individuals with subthreshold depression based on the Social Participation Competence Framework.

Read the detailed description

Subthreshold depression (SD) represents a state of psychological sub-health between normal individuals and clinical depression. It constitutes a high-risk stage for developing major depressive disorder and a critical window for alleviating depressive symptoms. An editorial published in JAMA emphasized that research on subthreshold depression holds significant implications for exploring the prevention and treatment of depression. Therefore, prioritizing subthreshold depression in older adults and implementing early interventions is essential. Global population aging has made mental health disorders a major public health issue. The World Health Organization reports that about 7% of people aged 60 and above worldwide suffer from depression; in China, the rates are 19.05% for mild and 12.17% for moderate-to-severe depressive symptoms. Subthreshold depression (StD) is defined as having at least two depressive symptoms (e.g., anhedonia, loss of interest) for over two weeks without meeting major depressive disorder criteria. Among older adults, StD prevalence is about 18.6%, with a 12%-15.83% risk of progressing to major depression within 2-3 years. Thus, StD represents a critical window for early prevention, and timely non-pharmacological interventions are vital to reverse progression and reduce family and social care burdens.

Virtual Reality (VR) technology, as a novel intervention method, possesses three key characteristics: immersion, interactivity, and simulation. By replicating real-world settings such as home and community environments, it enriches the training experience for elderly individuals with depression, helping them adapt to diverse social contexts and enhancing intervention outcomes. Horticultural therapy, an interdisciplinary approach integrating horticulture, medicine, and psychology, offers relatively low treatment costs with minimal side effects. It plays a positive role in promoting physical recovery, improving emotional well-being, and enhancing social skills. Increasingly, research teams are exploring VR-generated virtual horticultural environments and horticultural activity interventions. VR technology addresses multiple limitations of traditional horticultural therapy. VR-based gardening activities overcome temporal and spatial constraints, reduce the costs and risks associated with physical gardening, and provide richer, more personalized socialized horticultural settings and activities that cater to diverse patient needs. Therefore, integrating VR technology with horticultural therapy offers patients a more comprehensive, personalized, and effective mental health treatment plan, empowering them to lead healthier, more positive lives.

Being tested
Virtual Reality-Based Horticultural Intervention System, routine health management
Keywords
older adults, Subthreshold Depression, virutal reality, Gardening

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality-Based Horticultural Intervention SystemOther

    The system comprised six progressive horticultural tasks, each associated with a distinct plant: (1) Tomato Planting, (2) Corn Cultivation, (3) Strawberry Care, (4) Eggplant Harvest, (5) Rose Growing, and (6) Sunflower Expansion. All tasks followed the same eight standardized steps-land preparation, seed sowing, seedling fertilization, initial watering, secondary fertilization, secondary watering, pest removal, and harvesting-but were arranged in a clear gradient of increasing difficulty. This progression was reflected in expanding planting scales, escalating task complexity, heightened cognitive load, more refined judgment requirements, and varying demands on operational precision. Each task was performed individually by the participant using the VR headset, without any multiplayer or collaborative components, as the system was designed for personalized, self-paced intervention.

  • routine health managementOther

    This arm of seniors maintains their daily routines and participates regularly in the nursing home's daily activities.

Study groups in NCT07275034
Study groupRoleWhat they receive
Virtual Reality InterventionExperimentalThis group utilized a virtual reality intervention system based on horticultural planting, designed and developed by the research team.
Receives: Other: Virtual Reality-Based Horticultural Intervention System; Other: routine health management
Routine CareExperimentalThe control group received routine health management over the 6-week period, which encompassed assistance with daily living activities, basic medical care (including regular health check-ups and medication management), recreational activities, and environmental cleaning, with no additional structured intervention.
Receives: Other: routine health management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subthreshold Depression

    The Center for Epidemiological Surveys Depression Scale (CES-D) was developed by Rirodiff at the National Institute of Mental Health in the United States. It is designed for screening depressive symptoms in older adults, comprising 20 items. Each question assesses one symptom, covering 20 distinct symptoms in total. The total score ranges from 0 to 60 points. A score ≤15 indicates no depressive symptoms, 16-19 suggests possible depressive symptoms, and ≥20 confirms depressive symptoms. The Cronbach's alpha coefficient for the Chinese population is 0.90. It is one of the most commonly used subthreshold depression epidemiological survey tools, with existing studies defining CES-D ≥16 as subthreshold depression.

    Translated with DeepL.com (free version)

    Measured: The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks .

Secondary outcomes (7)
  1. General cognitive function

    The Montreal Coanitive Asessment Scale,developed by Nasreddine in 2004 to assess participants'general cognitive function, covers eight areasof cognitive assessment, including visuospatial and executive function, naming, memory, attention, speech, abstraction, delayed recall, andorientation. The Changsha version of the Montreal Cognitive Assessment Scale was used in this study, and its Cronbach's a coeficient was 0.846,retest reliability was 0.974, and investigator reliability was 0.969. The score of the Montreal Cognitive Assessment Scale ranges from 0 to 30points. The higher the score,the better the cognitive function ofthe study subjects. The iliterate group s13, the primary school group s19 and thejunior high school and above group s24 can be judged as impaired cognitive function to correct the bias caused by education level.

    Measured: The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.

  2. Anxiety Condition

    The self-rating anxiety scale (SAS) was designed and developed by Zung in the United States in 1971 to assess the severity of anxiety symptoms in individuals. It demonstrates good reliability and validity, with a split-half reliability coefficient of 0.696, test-retest reliability of 0.777, and internal consistency of 0.82. Additionally, it exhibits good construct validity . The scale comprises 20 items, with items 5, 9, 13, 17, and 19 scored in reverse. The scale employs a 1-4 rating scale (1 = never or rarely; 2 = a small portion of the time; 3 = a considerable portion of the time; 4 = most or all of the time). Individuals complete the scale based on their experiences during the past week. The total score is multiplied by 1.25, rounded to the nearest whole number to obtain a standardized score, which serves as the statistical indicator. A higher standardized score indicates more severe anxiety levels

    Measured: The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately

  3. Self-Efficacy

    The General Self-Efficacy Scale (GSES), developed by Schwarzer et al , was used. It consists of 10 items rated on a 4-point Likert scale, ranging from 1 (strongly disagree) to 4 (strongly agree). Higher total scores indicate higher levels of self-efficacy. In this study, the Cronbach α coefficient was 0.81.

    Measured: The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.

  4. Sleep Quality

    This study employed the Pittsburgh Sleep Quality Index (PSQI) developed by Buysse et al. in 1989 to assess patients' sleep quality over the preceding month. The 19-item questionnaire comprises seven components: subjective sleep quality, sleep onset latency, sleep duration, sleep efficiency, sleep disturbances, hypnotic medication use, and daytime functioning. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. The Cronbach's alpha coefficient for this scale is 0.85.

    Measured: The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.

  5. System Usability

    System Usability Scale (SUS) Developed by Brooke et al., the scale used in this study is the Chinese version of the System Usability Scale translated and revised by Chinese scholars including Li Yongfeng. This scale is unidimensional and consists of 10 items. It employs a 5-point Likert scale, with scores ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree"). Positive items (Items 1, 3, 5, 7, 9) are scored positively: Actual item score = Item rating - 1. Negative items (Items 2, 4, 6, 8, 10) are scored negatively: Actual item score = 5 - Item rating. If an item is left blank, it is assigned a score of 3. The total scale score = sum of all item scores × 2.5. The scale has a maximum score of 100 points, with scores >60 considered usable, 70 considered good, ≥80 considered excellent, and ≥90 considered outstanding. The Cronbach's alpha coefficient for this scale is 0.91.

    Measured: The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.

  6. Simulator Sickness

    The Simulator Sickness Questionnaire(SSQ) developed by Kennedy et al. in 1993, is a widely used tool for assessing the subjective severity of simulator sickness symptoms. The SSQ consists of pre- and post-experiment sections. The pre-experiment section employs the Pensacola Motion Sickness Questionnaire (MSQ) to gather information about participants' current physical condition and prior simulator experience. The post-experiment section measures symptom severity on a four-point scale (0-3) for each symptom. SSQ items can be grouped into three factors: nausea (e.g., sweating, difficulty concentrating, gastric awareness), eye movement disturbances (e.g., headache, eye fatigue, blurred vision), and disorientation (e.g., head fullness, dizziness with eyes open/closed, vertigo). The SSQ can be scored in two ways: (1) Calculate the score for each factor by summing the scores of all relevant items (each factor includes 7 items), with a score range of 0-179.5

    Measured: The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.

  7. Immersion Presence

    The Immersion Presence Questionnaire (IPQ) was employed to evaluate users' sense of immersion in the experience. Developed by Schubert et al., this questionnaire was subsequently translated into Chinese and validated for reliability and validity by Liang Jiahui et al. The results demonstrated its strong reliability and validity, with a Cronbach's α coefficient of 0.82. The Chinese version comprises 13 items organized into three dimensions: spatial presence (Items 2, 3, 9), involvement (Items 1, 6, 10), and realism (Items 4, 5, 8, 11, 12, 13). Item 7 reflects overall presence. Each item employs a 7-point Likert scale ranging from -3 to 3 points, with items 10 and 12 reverse-scored. The total score ranges from -39 to 39 points, where a higher score indicates a better sense of presence experience in the virtual reality environment.

    Item 7 reflects overall presence. Each item uses a 7-point Likert scale ranging from -3 to 3 points, with items 10 and 12 reverse-scored. The total score rang

    Measured: The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2025
  2. Study start10 Nov 2025
  3. Primary completion16 Jan 2026
  4. Study completion16 Jan 2026

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07275034
Sponsor's protocol ID
K2025-06-025
Status last verified
Aug 2026
First submitted
27 Nov 2025
Last updated
27 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality-Based Horticultural Intervention System and routine health management in people with Subthreshold Depression, run by Fujian Medical University 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 7 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 27 Aug 2026. 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?

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?

Subthreshold Depression (time frame: The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks .). 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 27 Aug 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in