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

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2025

Completed
17 days until next milestone

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
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2026

Completed
Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

November 27, 2025

Last Update Submit

August 25, 2026

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 0,6 weeks .

Secondary Outcomes (7)

  • General cognitive function

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

  • Anxiety Condition

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

  • Self-Efficacy

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

  • Sleep Quality

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

  • System Usability

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

  • +2 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-Based Horticultural Intervention SystemOther: routine health management

Routine Care

EXPERIMENTAL

The 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.

Other: routine health management

Interventions

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.

Virtual Reality Intervention

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

Routine CareVirtual Reality Intervention

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nursing school of Fujian Medical university

Fujian, Fuzhou, 350001, China

Location

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

November 10, 2025

Primary Completion

January 16, 2026

Study Completion

January 16, 2026

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations