- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07275034
Et hageplanteprogram basert på virtuell virkelighet for eldre med subterskelsdepresjon
Et virtuell virkelighet-basert hagebruksplantingsprogram for eldre med subterskel depresjon: En randomisert kontrollert pilotstudie
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Subterskjeldsdepresjon (SD) representerer en tilstand av psykologisk subhelse mellom normale individer og klinisk depresjon. Den utgjør et høyt risikostadium for utvikling av major depresjonslidelse og et kritisk vindu for å lindre depressive symptomer. En lederartikkel publisert i JAMA understreket at forskning på subterskjeldsdepresjon har betydelige implikasjoner for å utforske forebygging og behandling av depresjon. Derfor er det avgjørende å prioritere subterskjeldsdepresjon hos eldre og implementere tidlige intervensjoner. Flere studier indikerer at sosial deltakelse, som en av de modifiserbare faktorene for depresjon hos eldre, aktivt kan forsinke debut og progresjon av aldersdepresjon. Sosial deltakelse omfatter flerdimensjonale aktiviteter der eldre utveksler materielle og emosjonelle ressurser og får sosial anerkjennelse. Disse inkluderer deltakelse i aktiviteter, oppfyllelse av sosiale roller, mellommenneskelige interaksjoner, utnyttelse av sosiale ressurser og gjenoppretting av personlig verdi. Faktorer som pensjonering, sykdom eller fysisk tilbakegang fører ofte til en innsnevring av eldres eksisterende sosiale nettverk og svekket sosial tilknytning. Dette resulterer i redusert omfang og hyppighet av sosial deltakelse, potensielt utløsende eller forverrende depressive lidelser. Omvendt undergraver depressive lidelser selv, gjennom kjerneymptomer som nedstemthet og redusert interesse, videre eldres vilje og evne til å opprettholde relasjoner og aktivt delta i aktiviteter, og skaper en ond sirkel. En 2024-studie publisert i The Lancet indikerer at eldre med høyt nivå av sosial deltakelse viser betydelig lavere depresjonsrisiko sammenlignet med de med lav deltakelse. Tilsvarende antyder en 2023 Nature Aging-studie at sosial deltakelse kan redusere depresjon ved å lindre stress, betennelse og cerebrovaskulær skade, og derved bevare hjernehelse, bygge kognitiv reserve og dempe depressive lidelser.
Virtual Reality (VR)-teknologi, som en ny intervensjonsmetode, besitter tre nøkkelegenskaper: immersjon, interaktivitet og simulering. Ved å gjenskape virkelige omgivelser som hjem- og samfunnsmiljøer, beriker den treningserfaringen for eldre med depresjon, hjelper dem tilpasse seg ulike sosiale kontekster og forbedrer intervensjonsresultater. Hagebruksterapi, en tverrfaglig tilnærming som integrerer hagebruk, medisin og psykologi, tilbyr relativt lave behandlingskostnader med minimale bivirkninger. Den spiller en positiv rolle i å fremme fysisk rehabilitering, forbedre emosjonell velvære og forbedre sosiale ferdigheter. I økende grad utforsker forskningsteam VR-genererte virtuelle hagebruksmiljøer og hagebruksaktivitetsintervensjoner. VR-teknologi adresserer flere begrensninger ved tradisjonell hagebruksterapi. VR-baserte hageaktiviteter overvinner tidsmessige og romlige begrensninger, reduserer kostnadene og risikoene forbundet med fysisk hagearbeid, og tilbyr rikere, mer personliggjorte sosialiserte hagebruksinnstillinger og aktiviteter som imøtekommer ulike pasientbehov. Derfor tilbyr integrering av VR-teknologi med hagebruksterapi pasienter en mer omfattende, personliggjort og effektiv mental helsebehandlingsplan, som gir dem mulighet til å leve sunnere, mer positive liv.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Fuzhou
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Fujian, Fuzhou, Kina, 350001
- Nursing school of Fujian Medical university
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier:
- Alder ≥ 60 år
- Oppfyller subterskelnedepresjonsdiagnostiske kriterier: CES-D score ≥ 16 på Center for Epidemiological Survey, Depression Scale (CES-D) brukt i epidemiologiske undersøkelser (dette kriteriet er bredt akseptert i sammenlignbare studier)
- Ingen kommunikasjonshindringer i syn, hørsel eller tale
- Informert samtykke
Eksklusjonskriterier:
- Insulinavhengig diabetes
- Skjoldbruskkjertelsykdom
- Nylig eksponering for et større traumatisk stresshendelse, uten risiko for selvmord
- Deltar for tiden i andre lignende studier
- Klinisk diagnostisert med psykiske lidelser som depresjon eller schizofreni
- Tar for tiden antidepressiv medisin
- Alvorlig kognitiv svikt
- Alvorlig fysisk sykdom eller organisk lidelse med nedsatt egenomsorgsevne
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Intervensjon med virtuell virkelighet
Denne gruppen benyttet et virtual reality-intervensjonssystem basert på hagearbeid, designet og utviklet av forskningsteamet.
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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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Subthreshold Depression
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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General cognitive function
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- K2025-06-025
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
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