- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07530952
Grøn VR til Depression (VR&depression)
Virtuelle Naturerfaringer som Supplement i Behandlingen af Moderat Depression
Depression er en almindelig mental sundhedstilstand, der kan forårsage lavt humør, mangel på energi, søvnproblemer og vanskeligheder i den daglige funktion. Mange mennesker med mild til moderat depression modtager ikke tilstrækkelig behandling på grund af barrierer såsom begrænset adgang til tjenester, stigmatisering eller lav motivation til at søge hjælp. Fysisk aktivitet og kontakt med naturen har vist sig at forbedre mental sundhed, og aktiviteter udført i naturlige miljøer ("grøn motion") kan give yderligere psykologiske fordele sammenlignet med motion indendørs. Dog kan mennesker med depression opleve barrierer for at deltage i udendørsaktiviteter, såsom lav motivation, begrænset adgang til naturlige miljøer eller ugunstige vejrforhold.
Virtual reality (VR) teknologi kan simulere immersive naturmiljøer og kan give en måde at opleve naturen indendørs på. VR-formidlede oplevelser af naturen (eller "virtuel natur") kan give lignende psykologiske fordele som virkelige naturlige oplevelser. Desuden, da virtuelle naturlige oplevelser har vist sig at fremkalde øget følelse af naturforbindelse og intention om at udføre grøn motion, hvilket igen kan støtte øget deltagelse i faktisk grøn motion. Mens virtuelle naturinterventioner har vist lovende resultater i forskellige sundhedskontekster og betragtes som sikre og gennemførlige, er der kun lavet lidt forskning, der har undersøgt deres effekter af at integrere sådant medium i kliniske standardbehandlinger for depression.
Formålet med dette studie er at undersøge, om virtuel natur kan være et effektivt supplement til standardbehandling for patienter med mild til moderat depression. Specifikt vil studiet evaluere, om kombinationen af standardbehandling og virtuel natur forbedrer humør og reducerer depressive symptomer sammenlignet med sædvanlig behandling. Studiet vil også undersøge, om interventionen påvirker deltagernes motivation til at deltage i fysisk aktivitet og udendørs grøn motion over tid. Endelig vil studiet undersøge mulige forskelle mellem to tilgange til at levere virtuelle naturlige oplevelser til patienter i behandling for depression, nemlig en "high-end" og laboratoriebaseret tilgang kontra en "low-end" og selvstyret tilgang.
Deltagere vil blive rekrutteret fra en psykiatrisk ambulatoriumsklinik, der behandler personer med depression og angstlidelser. Kvalificerede deltagere vil være voksne diagnosticeret med mild til moderat depression. Patienter med yderligere diagnose for demens eller psykotisk sygdom eller anden alvorlig somatisk sygdom vil blive udelukket. Deltagere vil blive tilfældigt tildelt en af tre grupper: (1) en "high-end" og laboratoriebaseret VR-intervention kombineret med standardbehandling, (2) en "low-end" og selvstyret VR-intervention kombineret med standardbehandling, eller (3) en kontrolgruppe, der kun modtager standardbehandling. Interventionen vil vare tre uger, og deltagere vil blive vurderet ved baseline, umiddelbart efter den første session, efter interventionsperioden og ved opfølgning.
Studiet vil undersøge flere resultater, både for at teste akutte og longitudinelle effekter. Specifikt, for at teste for akutte effekter af de to VR-tilgange, omfatter testede resultater affektiv tilstand, følelser af naturforbindelse, intention om at udføre grøn motion og oplevelser med det virtuelle miljø (såsom nydelse, immersion og mulige bivirkninger som cyber sickness). For at teste de longitudinelle effekter omfatter testede resultater humør, symptomer på depression og angst og ændringer i fysisk aktivitet og naturforbindelse.
Den primære hypotese er, at patienter, der modtager virtuel natur udover deres sædvanlige behandling, vil opleve større forbedringer i humør og depressive symptomer sammenlignet med patienter, der kun modtager standardbehandling. En sekundær hypotese er, at eksponering for virtuel natur kan øge deltagernes motivation og engagement i virkelig udendørs fysisk aktivitet over tid. Endelig forventes det, at den high-end og laboratoriebaserede VR-intervention vil give mere positive overordnede effekter.
Denne forskning vil give ny viden om, hvorvidt virtuelle naturlige oplevelser kan støtte mental sundhedsbehandling og hjælpe mennesker med depression med at blive mere fysisk aktive og forbundet med naturen. Hvis effektiv, kunne interventionen tilbyde et lavpris og tilgængeligt supplement til eksisterende behandlingstilgange for depression.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Hamar, Norge
- Sykehus Innlandet
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- kan tale og læse norsk
- diagnosticeret med mild til moderat depression
Eksklusionskriterier:
- yderligere diagnose for demens eller psykotisk sygdom eller anden alvorlig somatisk sygdom
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Kontrol (TAU)
Standardbehandling med terapeut
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Standardbehandling med terapeut
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Eksperimentel: Studiebaseret
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Standardbehandling med terapeut
Højkvalitets VR-oplevelse leveret af forskeren i et studie, leveret ugentligt, bestående af en simuleret naturvandring leveret gennem et højkvalitets VR-system forbundet til et manuelt drevet løbebånd.
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Eksperimentel: Selvstyret
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Standardbehandling med terapeut
En begrænset VR-oplevelse, som deltagerne selv administrerer.
Efter et introduktionsmøde med forskeren modtager deltagerne for interventionens varighed et selvstændigt VR-headset med en forudindstillet samling af virtuelle naturerfaringer.
Deltagerne opfordres til at bruge headsettet dagligt.
Tiden brugt med VR-headsettet registreres gennem enheden.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Beck depression inventory II (BDI-II)
Tidsramme: Baseline; post-intervention (week 3); follow-up (week 12).
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The BDI-II is a 21-item self-report questionnaire designed to measure the severity of depression. The total score is calculated by summing the ratings (0-3) for all 21 items, with minimum score 0 (no or minimal depressive symptoms) and maximum score 63 (severe, high-level depressive symptoms). A Norwegian translation of the scale commonly used in clinical settings is used in the study. |
Baseline; post-intervention (week 3); follow-up (week 12).
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Beck anxiety inventory (BAI)
Tidsramme: Baseline; post-intervention (week 3); follow-up (week 12).
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The BAI is a 21-item self-report questionnaire used to measure the severity of anxiety in adults and adolescents. Each item is rated from 0 ("not at all") to 3 ("a lot"). The total score is calculated by summing the ratings for all 21 items (minimum value 0 and maximum value 63), with higher scores indicating greater severity of anxiety. A Norwegian translation of the scale commonly used in clinical settings is used in the study. |
Baseline; post-intervention (week 3); follow-up (week 12).
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Hopkins symptom checklist (HSCL-10)
Tidsramme: Baseline; post-intervention (week 3); follow-up (week 12).
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The HSCL-10 is a 10-item self-report questionnaire designed to screen for symptoms of anxiety and depression, commonly used in both clinical and epidemiological studies to measure psychological distress. It includes 4 items related to anxiety and 6 items related to depression, focusing on symptoms experienced during the past week. Each item is rated on a four-point scale (1 = "Not at all"; 2 = "A little"; 3 = "Quite a lot"; 4 = "Extremely"). The score is calculated by taking the mean of all item scores. The minimum Value is 1.0 (no psychological distress) while the maximum Value 4.0 (extreme psychological distress). A Cut-off Point is set at a mean score of 1.85 to identify individuals experiencing significant mental health distress. A Norwegian translation of the scale commonly used in clinical settings is used in the study. |
Baseline; post-intervention (week 3); follow-up (week 12).
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Leisure time exercise questionnaire (LTEQ)
Tidsramme: Baseline; post-intervention (week 3); follow-up (week 12).
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The LTEQ is a self-administered tool designed to assess the frequency and intensity of a person's leisure-time physical activity in a regular week (7 days). It measures how many times per week a person engages in strenuous, moderate, and mild/light physical activity for at least 15 minutes. In this study, a modified version was also used to measure "active commuting", defined in a caption as "Walkin, running, biking to and from destinations such as work, the grocery, etc." The participant is required to report the number of times they engage in each level of intensity (strenuous, moderate, and mild/light) during a regular week. Examples are provided for each level of intensity. Higher scores indicate higher levels of activity. The total score is calculated through the following formula: (n strenuous x 9) + (n moderate x 5) + (n mild/light x 3). A Norwegian translation is used. |
Baseline; post-intervention (week 3); follow-up (week 12).
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Intention to perform green exercise (INT-GE)
Tidsramme: Baseline; immediately after the 1st VR exposure; post-intervention (week 3); follow-up (week 12).
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The INT-GE is a questionnaire component designed to measure an individual's motivation, plans, and likelihood of engaging in physical activity within natural environments (e.g., parks, forests, coasts). It is often developed based on the Theory of Planned Behaviour (TPB) to predict future green exercise behaviour. The scale contains five items, each rated on a 1-7 Likert scale, with the total score calculated as the mean of all items. The minimum score is 1.0 (no intention to perform green exercise), while the maximum is 5.0 (strong intention to perform green exercise). A Norwegian translation of the scale is used. |
Baseline; immediately after the 1st VR exposure; post-intervention (week 3); follow-up (week 12).
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Connectedness with nature scale (CNS)
Tidsramme: Baseline; immediately after the 1st VR exposure; post-intervention (week 3); follow-up (week 12).
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The state version of the CNS measures an individual's affective, experiential connection to the natural world at a given moment ("right now"). Based on the previous trait version of the scale, the state version is sensitive to acute changes. It contains 13 items, which are rated on a 1-7 Likert scale (1 = "Strongly disagree"; 7 = "Strongly agree"). The total score is calculated as the mean of all items, with lower scores (minimum value = 1.0) indicating a weaker sense of connectedness, while the higher scores (maximum value = 7.0) indicate a stronger sense of connectedness. A Norwegian translation of the scale is used. |
Baseline; immediately after the 1st VR exposure; post-intervention (week 3); follow-up (week 12).
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Affect Scale (PAAS)
Tidsramme: Baseline; immediately after the 1st VR exposure; post-intervention (week 3); follow-up (week 12).
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The PAAS is a 12-item self-report questionnaire designed to measure feeling states. It evaluates emotional responses across four distinct subscales (Positive affect, Negative affect, Tranquillity, and Fatigue) and is especially sensitive to acute changes associated with physical activity. The PAAS consists of 12 items (three items per subscale), each describing a feeling (e.g., "Energetic", "Discouraged", "Relaxed", "Worn-out"). Participants rate their current feelings on a 5-point Likert scale, commonly ranging from 0 ("do not feel") to 4 ("feel very strongly"). Mean scores are calculated for each subscale, with a minimum possible score of 0 and a maximum of 4, with higher scores indicating higher levels for the subcategory. A Norwegian translation is used. |
Baseline; immediately after the 1st VR exposure; post-intervention (week 3); follow-up (week 12).
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Nydelse under VR-oplevelsen
Tidsramme: Umiddelbart efter den 1. VR-eksponering
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Dette er et enkelt punkt, designet af forskerne, hvor deltageren bedes vurdere deres grad af enighed med følgende udsagn: "Denne oplevelse var behagelig". Punktet vurderes på en 0-10 Likert-skala, hvor lavere værdier (minimum = 0) indikerer ingen fornøjelse, mens højere værdier (maksimum = 10) indikerer højere grader af fornøjelse. Der anvendes en norsk oversættelse. |
Umiddelbart efter den 1. VR-eksponering
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Sense of presence during the VR experience
Tidsramme: Immediately after the 1st VR exposure
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The scale assesses the extent to which participants perceive themselves to be immersed or embedded within a virtual environment (i.e., presence). Each item relates to different aspects that can influence a person's sense of presence either positively (Being there, Realism, Sense of reality) or negatively (Awareness, Other persons, External noises, Flatness, Movement lag). The items are formulated as statements, each participant being asked to rate the extent to which they agreed with each of them on an 11-point Likert scale (0 = absolutely disagree, 10 = absolutely agree). Each item is scored and treated individually. For Being there, Realism, and Sense of reality, higher scores indicate stronger sense of presence, hence greater effectiveness of the VR experience. For the other items, higher scores indicate a poorer sense of presence. |
Immediately after the 1st VR exposure
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Simulator sickness questionnaire (SSQ)
Tidsramme: Immediately after the 1st VR exposure
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The SSQ measures symptoms similar to motion sickness but tailored to computer-based simulations. It asks participants to rate 16 symptoms (e.g., headache, eye strain, dizziness, nausea) on a four-point scale (0 = None; 1 = Slight; 2 = Moderate; 3 = Severe). The 16 symptoms are grouped into three subscales (Nausea, Oculomotor, and Disorientation), which are weighted and summed to calculate a total score. The minimum score is 0 (no symptoms, ideal outcome), and the maximum is 300 (extremely severe symptoms). A Norwegian translation is used |
Immediately after the 1st VR exposure
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Perceived Environmental Restorativeness
Tidsramme: Immediately after the 1st VR exposure
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The Perceived Environmental Restorativeness is a self-reported measure of an environment's potential to help individuals recover from mental fatigue, stress, and cognitive overload according to the Attention-Restoration Theory. It contains 16 items, grouped in four subcategories: Fascination (5 items), Being Away (2 items), Extent/Coherence (4 items), and Compatibility (5 items). Each item is rated on a 0-10 Likert scale. The score of each subcategory is calculated as the mean of the related items. For Fascination, Being Away, and Compatibility, lower scores (minimum = 0.0) indicate smaller restorative potential, while higher scores (maximum = 10.0) indicate larger restorative potential. Unless the scores for Extent/Coherence are reversed, lower scores (minimum = 0.0) indicate larger restorative potential, while higher scores (maximum = 10.0) indicate smaller restorative potential. A Norwegian translation of the scale is used. |
Immediately after the 1st VR exposure
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Hjælpsomme links
- Calogiuri, G., Litleskare, S., Fagerheim, K. A., Rydgren, T. L., Brambilla, E., & Thurston, M. (2018). Experiencing nature through immersive virtual environments: Environmental perceptions, physical engagement, and affective responses during a simulated
- Godin, G., & Shephard, R. (1985). A simple method to assess exercise behavior in the community. Canadian journal of applied sport sciences. Journal canadien des sciences appliquees au sport, 10(3), 141-146.
- Hartig, T. (1996). Validation of a measure of perceived environmental restorativeness. Goteborg psychological reports, 26(7).
- Mayer, F. S., & Frantz, C. M. (2004). The connectedness to nature scale: A measure of individuals' feeling in community with nature. Journal of environmental psychology, 24(4), 503-515.
- Nichols, S., Haldane, C., & Wilson, J. R. (2000). Measurement of presence and its consequences in virtual environments. International Journal of Human-Computer Studies, 52(3), 471-491.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 258745
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Depression, Mild eller Moderet
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Stanford UniversityRekrutteringDepression | Depression Moderat | Depression MildForenede Stater
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University of California, San FranciscoRekrutteringDepression Moderat | Depression MildForenede Stater
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University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Aktiv, ikke rekrutterendeDepression Moderat | Depression Mild | Depression, teenagerForenede Stater
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Norwegian Institute of Public HealthGöteborg University; University of Bergen; The Research Council of Norway; Sussex...Afsluttet
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Norwegian Institute of Public HealthGöteborg University; University of Bergen; University of Tromso; Sussex Partnership... og andre samarbejdspartnereAktiv, ikke rekrutterendeAngst | Mild til moderat depressionNorge
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National University of SingaporeRekruttering
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Annecto LLCHoly Redeemer HospitalAfsluttetMild til moderat depressionForenede Stater
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Northern Illinois UniversityUniversity Autonoma de Santo DomingoAfsluttetDepression Moderat | Depression MildForenede Stater, Dominikanske republik
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Göteborg UniversityVastra Gotaland RegionRekrutteringDepression Moderat | Depression MildSverige
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Federal Research Center of Fundamental and Translational...AfsluttetDepression Moderat | Depression MildDen Russiske Føderation
Kliniske forsøg med Standardbehandling
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Hospital Clinic of BarcelonaUkendtMisbrug af marihuanaSpanien
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Oklahoma State UniversityUniversity of Oklahoma; University of Minnesota; Case Western Reserve University og andre samarbejdspartnereAfsluttet
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The Miriam HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Aktiv, ikke rekrutterende
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Kaiser PermanenteAfsluttet
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University of MiamiAktiv, ikke rekrutterendeProstatakræft | Prostata AdenocarcinomForenede Stater
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University of GeorgiaMakerere UniversityAfsluttet
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University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) og andre samarbejdspartnereAfsluttet
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Stanford UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)RekrutteringAutismespektrumforstyrrelse | AutismeForenede Stater
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Waikato HospitalWellington HospitalAfsluttetGlioblastomNew Zealand
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University of California, San FranciscoNational Institute on Drug Abuse (NIDA)Afsluttet