サブスレッショルドうつ病の高齢者向け仮想現実ベースの園芸植栽プログラム
サブスレッショルドうつ病の高齢者向けバーチャルリアリティ園芸プログラム:無作為化比較予備研究
調査の概要
状態
条件
詳細な説明
閾値下うつ病(SD)は、正常な個人と臨床的うつ病の間の心理的準健康状態を表します。 これは、大うつ病性障害を発症する高リスク段階であり、うつ症状を緩和する重要な窓口となります。 JAMAに掲載された編集記事は、閾値下うつ病に関する研究がうつ病の予防と治療の探求に重要な意味を持つと強調しています。 したがって、高齢者の閾値下うつ病を優先し、早期介入を実施することが不可欠です。 複数の研究は、高齢者のうつ病の修正可能な要因の一つとして、社会的関与が積極的に老年期うつ病の発症と進行を遅らせることができると示しています。 社会的関与は、高齢者が物質的および情緒的資源を交換し、社会的承認を得る多次元的活動を含みます。 これには、活動への参加、社会的役割の履行、対人交流、社会資源の利用、個人の価値の回復が含まれます。 退職、病気、または身体機能の低下などの要因は、しばしば高齢者の既存の社会的ネットワークの縮小と社会的つながりの弱体化につながります。 これにより、社会的関与の範囲と頻度が減少し、うつ病性障害を引き起こすか悪化させる可能性があります。 逆に、うつ病性障害自体は、低い気分や関心の減退などの核心症状を通じて、高齢者の関係維持と活動への積極的参加の意思と能力をさらに損ない、悪循環を生み出します。 The Lancetに掲載された2024年の研究は、高いレベルの社会的関与を持つ高齢者は、低い関与を持つ高齢者と比較して、うつ病リスクが著しく低いことを示しています。 同様に、2023年のNature Agingの研究は、社会的参加がストレス、炎症、脳血管障害を緩和することでうつ病を減少させ、それにより脳の健康を維持し、認知的予備能を構築し、うつ病性障害を軽減する可能性があることを示唆しています。<\/p>
バーチャルリアリティ(VR)技術は、新規介入方法として、没入性、相互作用性、シミュレーション性という3つの主要な特徴を持っています。 家庭や地域環境などの現実世界の設定を再現することで、うつ病の高齢者のトレーニング体験を豊かにし、多様な社会的文脈に適応するのを助け、介入成果を向上させます。 園芸療法は、園芸学、医学、心理学を統合した学際的アプローチであり、比較的低い治療コストと最小限の副作用を提供します。 それは身体の回復を促進し、情緒的健康を改善し、社会的スキルを向上させる上で積極的な役割を果たします。 ますます多くの研究チームが、VRで生成された仮想園芸環境と園芸活動介入を探求しています。 VR技術は、従来の園芸療法の複数の制限に対処します。 VRベースのガーデニング活動は、時間的および空間的制約を克服し、物理的ガーデニングに関連するコストとリスクを削減し、より豊かで個別化された社会化された園芸設定と活動を提供し、多様な患者のニーズに対応します。 したがって、VR技術と園芸療法を統合することは、患者により包括的で個別化され効果的な精神的健康治療計画を提供し、より健康的で前向きな生活を送る力を与えます。<\/p>
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Fuzhou
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Fujian、Fuzhou、中国、350001
- Nursing school of Fujian Medical university
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
適格基準:
- 年齢 ≥ 60歳
- 閾値下うつ病の診断基準を満たす: 疫学調査で使用される疫学的調査うつ尺度(CES-D)でCES-Dスコア ≥ 16(この基準は類似研究で広く採用されている)
- 視覚、聴覚、または言語にコミュニケーション障害がない
- インフォームド・コンセント
除外基準:
- インスリン依存性糖尿病
- 甲状腺疾患
- 最近の重大な外傷性ストレス事象への曝露(自殺のリスクなし)
- 現在他の類似研究に参加している
- うつ病や統合失調症などの精神障害の臨床診断を受けている
- 現在抗うつ薬を服用している
- 重度の認知障害
- 重度の身体疾患または自己介護能力が損なわれている器質性障害
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:仮想現実介入
このグループは、研究チームによって設計・開発された園芸植栽に基づくバーチャルリアリティ介入システムを利用しました。
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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.
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実験的: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.
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This arm of seniors maintains their daily routines and participates regularly in the nursing home's daily activities.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Subthreshold Depression
時間枠:The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks .
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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 .
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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General cognitive function
時間枠:The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.
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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.
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The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.
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Anxiety Condition
時間枠:The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately
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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
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The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately
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Self-Efficacy
時間枠:The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.
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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.
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The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.
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Sleep Quality
時間枠:The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.
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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.
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The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.
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System Usability
時間枠:The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.
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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.
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The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.
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Simulator Sickness
時間枠:The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.
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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
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The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.
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Immersion Presence
時間枠:The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.
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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.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- K2025-06-025
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IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。