- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07275034
경계선 우울증을 가진 노인을 위한 가상 현실 기반 원예 식물 프로그램
아임계 우울증을 가진 노인을 위한 가상현실 기반 원예 식물 심기 프로그램: 무작위 대조 예비 연구
연구 개요
상태
정황
상세 설명
서브스레숄드 우울증(SD)은 정상 개인과 임상 우울증 사이의 심리적 서브헬스 상태를 나타냅니다. 이는 주요 우울 장애 발병의 고위험 단계이자 우울 증상을 완화하기 위한 중요한 창구입니다. JAMA에 게재된 사설은 서브스레숄드 우울증에 대한 연구가 우울증 예방 및 치료 탐구에 중대한 의미를 지닌다고 강조했습니다. 따라서 노인 서브스레숄드 우울증을 우선시하고 조기 개입을 시행하는 것이 필수적입니다. 다수의 연구는 사회 참여가 노인 우울증의 수정 가능한 요인 중 하나로서 노인 우울증의 발병과 진행을 적극적으로 지연시킬 수 있음을 보여줍니다. 사회 참여는 노인이 물질적·정서적 자원을 교환하고 사회적 인정을 얻는 다차원적 활동을 포괄합니다. 여기에는 활동 참여, 사회적 역할 수행, 대인 상호작용, 사회적 자원 활용 및 개인적 가치 회복이 포함됩니다. 은퇴, 질병 또는 신체적 쇠퇴와 같은 요인들은 종종 노인의 기존 사회적 네트워크 축소와 사회적 연결 약화로 이어집니다. 이는 사회 참여 범위와 빈도를 감소시켜 우울 장애를 유발하거나 악화시킬 수 있습니다. 반대로, 우울 장애 자체는 낮은 기분과 흥미 감소와 같은 핵심 증상을 통해 노인의 관계 유지 및 활동 적극적 참여 의지와 능력을 더욱 훼손하여 악순환을 만듭니다. 2024년 The Lancet에 게재된 연구는 높은 수준의 사회 참여를 보이는 노인이 낮은 참여 노인에 비해 현저히 낮은 우울증 위험을 나타낸다고 밝혔습니다. 마찬가지로, 2023년 Nature Aging 연구는 사회 참여가 스트레스, 염증 및 뇌혈관 손상을 완화함으로써 뇌 건강을 보존하고 인지 예비력을 구축하며 우울 장애를 완화할 수 있음을 시사합니다.
가상 현실(VR) 기술은 새로운 개입 방법으로서 몰입감, 상호작용성 및 시뮬레이션이라는 세 가지 핵심 특성을 지닙니다. 가정 및 지역사회 환경과 같은 실제 환경을 재현함으로써 우울증 노인의 훈련 경험을 풍부하게 하여 다양한 사회적 맥락에 적응하도록 돕고 개입 효과를 향상시킵니다. 원예 치료는 원예, 의학 및 심리학을 통합한 학제적 접근법으로, 상대적으로 낮은 치료 비용과 최소한의 부작용을 제공합니다. 이는 신체 회복 촉진, 정서적 안녕 향상 및 사회적 기술 강화에 긍정적인 역할을 합니다. 점점 더 많은 연구팀이 VR로 생성된 가상 원예 환경과 원예 활동 개입을 탐구하고 있습니다. VR 기술은 전통적 원예 치료의 여러 한계를 해결합니다. VR 기반 정원 가꾸기 활동은 시간적·공간적 제약을 극복하고 실제 정원 가꾸기와 관련된 비용과 위험을 줄이며 다양한 환자 요구에 부응하는 더 풍부하고 개인화된 사회화 원예 환경과 활동을 제공합니다. 따라서 VR 기술과 원예 치료를 통합함으로써 환자에게 더 포괄적이고 개인화되며 효과적인 정신 건강 치료 계획을 제공하여 그들이 더 건강하고 긍정적인 삶을 살도록 돕습니다.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Fuzhou
-
Fujian, Fuzhou, 중국, 350001
- Nursing school of Fujian Medical university
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 나이 ≥ 60세
- 하위 임계치 우울증 진단 기준 충족: 역학 조사에 사용된 역학 조사 우울 척도(CES-D)에서 CES-D 점수 ≥ 16 (이 기준은 유사 연구에서 널리 채택됨)
- 시력, 청력 또는 언어에 의사소통 장애 없음
- 정보에 입각한 동의
제외 기준:
- 인슐린 의존성 당뇨병
- 갑상선 질환
- 최근 주요 외상적 스트레스 사건에 노출되었으며, 자살 위험이 없음
- 현재 다른 유사 연구에 참여 중
- 우울증이나 정신분열증과 같은 정신 장애로 임상적으로 진단됨
- 현재 항우울제 복용 중
- 심각한 인지 장애
- 자기 관리 능력이 손상된 심각한 신체 질환이나 기질적 장애
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 가상 현실 중재
이 그룹은 연구팀이 설계하고 개발한 원예 재배 기반의 가상 현실 중재 시스템을 활용했습니다.
|
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.
This arm of seniors maintains their daily routines and participates regularly in the nursing home's daily activities.
|
|
실험적: Routine Care
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.
|
This arm of seniors maintains their daily routines and participates regularly in the nursing home's daily activities.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Subthreshold Depression
기간: The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks .
|
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 .
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
General cognitive function
기간: The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.
|
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.
|
The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.
|
|
Anxiety Condition
기간: The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately
|
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
|
The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately
|
|
Self-Efficacy
기간: The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.
|
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.
|
The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.
|
|
Sleep Quality
기간: The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.
|
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.
|
The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.
|
|
System Usability
기간: The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.
|
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.
|
The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.
|
|
Simulator Sickness
기간: The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.
|
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
|
The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.
|
|
Immersion Presence
기간: The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.
|
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 |
The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .