NCT07160543

Brief Summary

This experimental trial investigates whether Virtual Reality Exposure (VRe) helps individuals reduce the difficulty of discarding personal possessions. It will also evaluate the psychological state impacts of the intervention. The main questions it aims to answer are: Does exposure-based intervention (VRe) reduce emotional distress and improve willingness to discard personal items? What psychological reactions (such as anxiety or emotional responses) do participants experience during and after these interventions?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 24, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
Last Updated

September 8, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

August 21, 2025

Last Update Submit

August 29, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in State Anxiety as measured by the State-Trait Anxiety Inventory (Y)- State subscale

    State anxiety is a psychological feature focused on how individuals experience at particular times (state anxiety). It will be assessed using the State subscale of the "State-Trait Anxiety Inventory (STAI-Y) State subscale", a validated self-report questionnaire commonly used in clinical and experimental research to measure transient levels of anxiety. Scores range from 20 to 80, with higher scores indicating greater state anxiety.

    Baseline (immediately before the intervention) and Post-intervention (immediately after completion of the single experimental session).

  • Change in Positive and Negative Affect as measured by the Positive and Negative Affect Schedule (PANAS)

    Positive and negative affect will be assessed using the Positive and Negative Affect Schedule (PANAS), a validated self-report questionnaire consisting of 20 items. The scale includes two subscales: Positive Affect (10 items; scores range 10-50) and Negative Affect (10 items; scores range 10-50). Higher scores indicate greater intensity of the corresponding affective state.

    Baseline (immediately before the intervention) and Post-intervention (immediately after completion of the single experimental session).

  • Frequency of Discarding Behavior (Behavioral Observation)

    Discarding behavior was assessed through direct behavioral observation during the experimental task. The measure consisted of recording whether participants discarded the personal object (in the imagination condition or in the virtual reality condition) and the frequency of this behavior within the single session.

    During the single experimental session (immediately after intervention).

Study Arms (2)

Arm 1: Imagination Exposure Condition

ACTIVE COMPARATOR

Participants were asked to close their eyes and vividly imagine discarding the personal object they had previously selected. The procedure was guided verbally by the experimenter, who instructed participants to mentally visualize moving the object from their personal space to a trash bin. The aim was to evoke the emotions and cognitive reactions associated with discarding in a controlled, internalized format. Intervention Assigned: Behavioral: Imagination Exposure.

Behavioral: Imagination Exposure

Arm 2: Non-immersive Virtual Reality Exposure Condition

EXPERIMENTAL

Participants interacted with a non-immersive, computer-based virtual environment displayed on a standard monitor. The environment simulated a household setting with various rooms and a trash bin located in a virtual garage. Participants navigated the space using a keyboard and mouse. They were presented with a digital representation of their own personal object, which had been previously photographed and embedded into the virtual scene. They were instructed to drag the object into the virtual trash bin, simulating the act of discarding. Intervention Assigned: Device: Non-immersive Virtual Reality Exposure.

Device: Non-immersive Virtual Reality Exposure

Interventions

Participants were guided to close their eyes and imagine discarding their personal object. The experimenter provided standardized verbal instructions to help participants visualize moving the item from their own space into a trash bin.

Also known as: IE, Imagination-based Exposure
Arm 1: Imagination Exposure Condition

Participants used a desktop computer to interact with a virtual household environment. Their personal object, photographed beforehand, was digitally embedded in the scene. Using keyboard and mouse, participants navigated to the virtual garage and dragged the object into a virtual trash bin. The experimenter remained present to provide support.

Also known as: VRE, Virtual Reality Exposure, Computer-based VR
Arm 2: Non-immersive Virtual Reality Exposure Condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults individuals from general population.

You may not qualify if:

  • A score of 4 or higher on the self-report item of the Hoarding Rating Scale Self-Report, which assesses difficulty in discarding possessions;
  • No evident signs of suicidal ideation, based on the scores of the Beck Depression Inventory-II, nor indications of alcohol or substance abuse, psychotic spectrum disorders, depressive disorders, organic mental disorders, or conditions associated with cognitive impairment;
  • Participants must report difficulty in discarding certain objects. Moreover, individuals have to complete online monitoring questionnaires via PC or smartphone.
  • Participants had to fill out a custom questionnaire evaluating each object based on two parameters: importance and difficulty in discarding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Padova

Padua, PD, Italy

Location

MeSH Terms

Conditions

Hoarding DisorderDisease

Condition Hierarchy (Ancestors)

Obsessive-Compulsive DisorderAnxiety DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Caterina Novara, PhD

    University of Padova

    PRINCIPAL INVESTIGATOR
  • Susanna Pardini, PhD

    Centre for Digital Health and Well-being, Fondazione Bruno Kessler, Trento, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
participants were randomly assigned to one of the two experimental conditions. Randomization was conducted using a simple, computer-generated sequence via the "RAND" function in Excel, ensuring allocation concealment. The randomization was unrestricted, meaning no blocking or stratification procedures were employed. This approach ensured that each participant had an equal probability of assignment to either condition, regardless of enrollment order or participant characteristics. The random allocation sequence generation and participant enrollment were performed by two master 's-level psychology students. Blinding procedures were implemented to reduce bias. Although participants were aware of the intervention they received due to the nature of the exposure tasks, outcome assessors were blinded to group allocation. The researchers responsible for data analysis and interpretation were not involved in the delivery of the interventions and did not have access to identifying participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2025

First Posted

September 8, 2025

Study Start

January 24, 2024

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

September 8, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations