NCT07275034

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2026

Completed
Last Updated

December 10, 2025

Status Verified

October 1, 2025

Enrollment Period

2 months

First QC Date

November 27, 2025

Last Update Submit

December 9, 2025

Conditions

Keywords

older adultsSubthreshold Depressionvirutal realityGardening

Outcome Measures

Primary Outcomes (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)

    The intervention was conducted in November 2025, and the evaluation time was 0,4,9 weeks .

Secondary Outcomes (8)

  • General cognitive function

    The intervention was conducted in September 2025, and the evaluation time was 0,4,9 weeks separately.

  • Anxiety Condition

    The intervention was conducted in November 2025, and the evaluation time was 0,4,9 weeks separately

  • Activities of Daily Living

    The intervention was conducted in September 2025, and the evaluation time was 0,4,9 weeks separately.

  • Social Support

    The intervention was conducted in September 2025, and the evaluation time was 0,4,9 weeks separately.

  • Sleep Quality

    The intervention was conducted in September 2025, and the evaluation time was 0,4,9 weeks separately.

  • +3 more secondary outcomes

Study Arms (2)

Virtual Reality Intervention

EXPERIMENTAL

This group utilized a virtual reality intervention system based on horticultural planting, designed and developed by the research team.

Other: Virtual Reality Garden System

Routine Care

EXPERIMENTAL

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

Other: Routine Care

Interventions

The system comprised six tasks. Task One was an individual task involving planting tomatoes by completing eight subtasks (tilling, sowing, fertilizing, watering, secondary fertilization, secondary watering, pest control, harvesting) in a virtual garden. Tasks Two through Five were two-player online cooperative tasks. Task 2 involves corn cultivation, with one participant planting while the other observes; Task 3 requires two participants to simultaneously plant strawberries in parallel within the virtual garden; Task 4 involves collaborative sunflower planting between two participants; Task 5 has experienced elderly participants assisting less experienced individuals in completing planting tasks; Task 6 enables three participants to share the joy of planting together in the virtual garden.

Virtual Reality Intervention

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

Routine Care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 60 years
  • Meets subthreshold depression diagnostic criteria: CES-D score ≥ 16 on the Center for Epidemiological Survey, Depression Scale (CES-D) used in epidemiological surveys (this criterion is widely adopted in comparable studies)
  • No communication barriers in vision, hearing, or speech
  • Informed consent

You may not qualify if:

  • Insulin dependent diabetes
  • Thyroid disease
  • Recent exposure to a major traumatic stress event, with no risk of suicide
  • Currently participating in other similar studies
  • Clinically diagnosed with mental disorders such as depression or schizophrenia
  • Currently taking antidepressant medication
  • Severe cognitive impairment
  • Severe physical illness or organic disorder with impaired self-care abilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nursing school of Fujian Medical university

Fujian, Fuzhou, 350001, China

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

November 27, 2025

First Posted

December 10, 2025

Study Start

February 1, 2026

Primary Completion

March 20, 2026

Study Completion

April 20, 2026

Last Updated

December 10, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations