- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07703397
VR-Based Behavioral Activation in Adults (VR-Dep)
11 juli 2026 uppdaterad av: KTO Karatay University
Behavioural Activation Intervention for Depression in a Virtual Reality Environment: Software Development and Effectiveness Study
Study Overview This study aims to evaluate the effectiveness of a newly developed Virtual Reality (VR) behavioral activation software program for individuals experiencing symptoms of depression.
Behavioral activation is a well-established psychological approach that helps individuals re-engage in positive, rewarding activities to reduce depressive symptoms and improve mood.
By translating this approach into an immersive VR environment using hand-tracking technology, the study explores whether technology-enhanced interventions can make therapy more accessible, engaging, and effective.
What the Study InvolvesParticipants in this study are randomly assigned to one of two groups:VR Behavioral Activation Group (Intervention): Participants in this group receive a structured behavioral activation program delivered entirely within a customized virtual reality environment.
Using advanced hand-tracking technology instead of traditional controllers, participants interact naturally with the virtual world to complete rewarding tasks and activities designed to boost engagement and mood.
Waitlist Control Group: Participants in this group do not receive the VR intervention during the active study period, serving as a comparison baseline to accurately measure the specific effects of the VR software.
However, to ensure ethical standards and support all participants, individuals in this group receive psychological education (psychoeducation) after the data collection phase is fully completed.
Research Goals The primary goal is to determine if the VR-focused behavioral activation program successfully reduces depression severity and enhances overall behavioral activation levels compared to the control group.
Additionally, researchers will evaluate how the intervention influences the body's behavioral approach and inhibition systems, providing insights into the underlying psychological mechanisms of VR-driven therapy.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This study was conducted to evaluate the effect of a virtual reality-based behavioral activation intervention on reducing depression symptoms.
Considering that depression negatively affects the daily functionality of individuals, an interactive behavioral activation intervention was developed in a virtual reality environment and the effectiveness of this intervention was tested.
A randomized controlled experimental design was used in the study.
The sample consisted of 50 participants with moderate to high levels of depression (experimental group = 25, control group = 25).
The experimental group received a behavioral activation intervention in a virtual reality environment for 4 weeks, while the control group was placed on a waiting list.
The intervention was delivered through virtual reality goggles in the morning.
In the virtual reality environment, participants simulated their morning routines, such as waking up, tidying the room, preparing breakfast, and getting dressed.
Sociodemographic Information Form, Behavioral Inhibition System and Behavioral Activation System Scale, Beck Depression Inventory, Presence Questionnaire, Virtual Reality Application Observation Form and Semi-Structured Interview Form for Virtual Reality Applications were used in the data collection process.
In the data analysis phase, Mixed Design Repeated Measures ANOVA was planned for behavioral activation and behavioral inhibition variables, and F1-LD-F1 design analysis was planned for depression and emotion regulation variables.
Studietyp
Interventionell
Inskrivning (Faktisk)
50
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Aydin, Turkiet (Türkiye), 09010
- Aydin Adnan Menderes University, Department of Psychology
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Being 18 years of age or older.
- Being literate (ability to read and write).
- Providing written informed consent by reading and signing the informed consent form.
- Having a score of 17 or above on the Beck Depression Inventory (BDI).
- Having a score of 41 or below on the Behavioral Activation subscale of the Behavioral Inhibition System and Behavioral Activation System (BIS/BAS) Scale.
- Having a score of 21 or above on the Behavioral Inhibition subscale of the Behavioral Inhibition System and Behavioral Activation System (BIS/BAS) Scale.
Exclusion Criteria:
- Having advanced vision problems that impair visual function, such as cataracts.
- Having uncorrected visual impairments, such as color blindness.
- Having any psychiatric or neurological disorder characterized by impaired reality testing.
- Being under 18 years of age.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: VR Behavioral Activation Group
Participants in this group receive a structured behavioral activation program delivered entirely within a customized virtual reality environment using hand-tracking technology to reduce depressive symptoms and enhance behavioral activation.
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A customized virtual reality (VR) software application developed for Meta Quest hardware, utilizing hand-tracking technology.
The software delivers a structured behavioral activation program designed to treat depressive symptoms by engaging participants in immersive, therapeutic activities.
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Övrig: Waitlist Control Group
Participants in this group serve as a comparison baseline and do not receive the VR intervention during the active study period.
After all post-test data collection is completed, they are provided with a psychological education (psychoeducation) program for ethical support.
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Participants remain on a waitlist during the active implementation phase to serve as a control group.
Upon completion of all post-test data collection, they receive a comprehensive psychological education (psychoeducation) program to ensure ethical treatment standards.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from Baseline in Beck Depression Inventory (BDI) Scores
Tidsram: Baseline (Pre-test) and Post-test (Week 4)
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The BDI is a 21-item self-report questionnaire used to measure the severity of depressive symptoms.
Each item is rated on a 4-point scale ranging from 0 to 3. Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms.
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Baseline (Pre-test) and Post-test (Week 4)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Mehmet Şakiroğlu, Assoc. Prof., Aydin Adnan Menderes University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
10 december 2024
Primärt slutförande (Faktisk)
22 september 2025
Avslutad studie (Faktisk)
1 november 2025
Studieregistreringsdatum
Först inskickad
4 juli 2026
Först inskickad som uppfyllde QC-kriterierna
11 juli 2026
Första postat (Faktisk)
14 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ali.yasin.kafes
- 2023/1-12 31906847/050.04.04-9 (Annan identifierare: Aydin Adnan Menderes Univ Social & Human Sci Ethics Comm)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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