Hoarding DisorderHD&VRNCT07160543
Non-Immersive Virtual Environments for the Treatment of Hoarding Disorder
A study testing Imagination Exposure and Non-immersive Virtual Reality Exposure in people with Hoarding Disorder and Virtual Reality Based Therapy, run by University of Padova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hoarding Disorder, Virtual Reality Based Therapy, General Population (no Specific Condition or Disease)
- What is being tested?
- Imagination Exposure and Non-immersive Virtual Reality Exposure
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jan 2024to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults individuals from general population.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Immersive Virtual Environments for the Treatment of Hoarding Disorder: A Preliminary Randomized Controlled Trial With a Mixed Factorial Design Based on a Non-Clinical Sample
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?
Read the detailed description
Researchers will compare the effects of VRe to Imagination exposure (Ie) to determine which method is more effective in reducing discarding-related difficulties. The trial is specifically designed for individuals from the general population who do not meet the criteria for hoarding disorder but experience significant emotional discomfort when trying to part with certain belongings. This subclinical presentation of hoarding-like behavior is common and often unaddressed despite its impact on well-being and living space management.
Participants completed online assessments and screening procedures to determine eligibility. They then participated in a one-time, in-lab exposure session using VRe or Ie techniques. Based on a standardized rating scale, each participant brought a personal object they had previously identified as difficult to discard but not overly emotionally charged. During the session, they engaged in either an immersive visualization of discarding the item (Ie) or a guided interaction with a virtual simulation of discarding the item (VRe). Participants were evaluated on psychological (e.g., state anxiety, positive and negative affect) and behavioral outcomes (e.g., actual discarding behavior) before and after the exposure. At the end of the session, participants reported whether they intended to discard the physical object in real life.
This study follows a single-session randomized controlled trial (RCT) design with partial blinding of outcome assessors. While participants were aware of the intervention type they received due to the nature of the exposure task, the researchers responsible for scoring and analyzing outcome data were blinded to group allocation to minimize bias and expectancy effects. This design enhances the rigor and objectivity of outcome comparisons between groups.
This preliminary RCT adopts an exploratory approach due to the limited empirical research on using non-immersive VR for discarding behaviors, particularly in non-clinical populations. Prior findings suggest that VR-based interventions can simulate real-world behavior and reduce emotional reactivity in anxiety-related contexts. However, existing studies have primarily focused on immersive VR applications and clinical populations, such as individuals with specific phobias or PTSD. The current study aims to fill this gap by assessing the potential of non-immersive, more accessible VR platforms in promoting behavioral change related to possession management.
The specific objectives of the study are:
To investigate whether exposure to a non-immersive VR environment can help individuals discard personally relevant objects more effectively than imagination-based exposure; To assess within- and between-group differences in emotional and behavioral responses-specifically state anxiety, positive and negative affect, and discarding behavior-before and after the intervention.
Given the preliminary nature of this research, the following two hypotheses guide the investigation:
Hypothesis 1: Participants in the VR exposure condition will be more likely to discard their object during or after the session than participants in the imagination-based exposure group. This hypothesis is grounded in preliminary evidence suggesting that non-immersive VR can support emotional regulation and task engagement by providing a structured yet low-pressure simulation of real-world scenarios.
Hypothesis 2: Both groups will show a reduction in state anxiety and negative affect, along with a potential increase in positive affect, from pre- to post-exposure. However, participants in the VR condition may exhibit greater improvements due to the virtual environment's interactive and visually grounded features, which may facilitate emotional processing and cognitive restructuring.
- Conditions
- Hoarding Disorder, Virtual Reality Based Therapy, General Population (no Specific Condition or Disease)
- Being tested
- Imagination Exposure, Non-immersive Virtual Reality Exposure
- Medical subject headings
- Hoarding Disorder, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagination ExposureBehavioural
Also called IE, Imagination-based Exposure
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.
Non-immersive Virtual Reality ExposureDevice
Also called VRE, Virtual Reality Exposure, Computer-based VR
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Non-immersive Virtual Reality Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: During the single experimental session (immediately after intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start24 Jan 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hoarding DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caterina Novara, PhD, Principal investigator, University of PadovaSusanna Pardini, PhD, Principal investigator, Centre for Digital Health and Well-being, Fondazione Bruno Kessler, Trento, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160543
- Sponsor's protocol ID
- DD0A28FFB2B4C63CFED6CC9BACC7A5
- Acronym
- HD&VR
- Status last verified
- May 2025
- First submitted
- 21 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pardini S, Olivetto S, Martinelli M, Novara C. Non-immersive virtual environments for the treatment of hoarding disorder: a preliminary randomized controlled trial based on a non-clinical sample. BMC Psychol. 2025 Sep 29;13(1):1078. doi: 10.1186/s40359-025-03446-w.
PubMed 41024139
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Immersive Virtual Environments for the Treatment of Hoarding Disorder: A Preliminary Randomized Controlled Trial With a Mixed Factorial Design Based on a Non-Clinical Sample
- ClinicalTrials.gov ID
- NCT07160543
- Acronym / sponsor ID
- HD&VR / DD0A28FFB2B4C63CFED6CC9BACC7A5
- Conditions
- Hoarding Disorder, Virtual Reality Based Therapy, General Population (no Specific Condition or Disease)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Researchers will compare the effects of VRe to Imagination exposure (Ie) to determine which method is more effective in reducing discarding-related difficulties. The trial is specifically designed for individuals from the general population who do not meet the criteria for hoarding disorder but experience significant emotional discomfort when trying to part with certain belongings. This subclinical presentation of hoarding-like behavior is common and often unaddressed despite its impact on well-being and living space management.
Participants completed online assessments and screening procedures to determine eligibility. They then participated in a one-time, in-lab exposure session using VRe or Ie techniques. Based on a standardized rating scale, each participant brought a personal object they had previously identified as difficult to discard but not overly emotionally charged. During the session, they engaged in either an immersive visualization of discarding the item (Ie) or a guided interaction with a virtual simulation of discarding the item (VRe). Participants were evaluated on psychological (e.g., state anxiety, positive and negative affect) and behavioral outcomes (e.g., actual discarding behavior) before and after the exposure. At the end of the session, participants reported whether they intended to discard the physical object in real life.
This study follows a single-session randomized controlled trial (RCT) design with partial blinding of outcome assessors. While participants were aware of the intervention type they received due to the nature of the exposure task, the researchers responsible for scoring and analyzing outcome data were blinded to group allocation to minimize bias and expectancy effects. This design enhances the rigor and objectivity of outcome comparisons between groups.
This preliminary RCT adopts an exploratory approach due to the limited empirical research on using non-immersive VR for discarding behaviors, particularly in non-clinical populations. Prior findings suggest that VR-based interventions can simulate real-world behavior and reduce emotional reactivity in anxiety-related contexts. However, existing studies have primarily focused on immersive VR applications and clinical populations, such as individuals with specific phobias or PTSD. The current study aims to fill this gap by assessing the potential of non-immersive, more accessible VR platforms in promoting behavioral change related to possession management.
The specific objectives of the study are:
To investigate whether exposure to a non-immersive VR environment can help individuals discard personally relevant objects more effectively than imagination-based exposure; To assess within- and between-group differences in emotional and behavioral responses-specifically state anxiety, positive and negative affect, and discarding behavior-before and after the intervention.
Given the preliminary nature of this research, the following two hypotheses guide the investigation:
Hypothesis 1: Participants in the VR exposure condition will be more likely to discard their object during or after the session than participants in the imagination-based exposure group. This hypothesis is grounded in preliminary evidence suggesting that non-immersive VR can support emotional regulation and task engagement by providing a structured yet low-pressure simulation of real-world scenarios.
Hypothesis 2: Both groups will show a reduction in state anxiety and negative affect, along with a potential increase in positive affect, from pre- to post-exposure. However, participants in the VR condition may exhibit greater improvements due to the virtual environment's interactive and visually grounded features, which may facilitate emotional processing and cognitive restructuring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Imagination Exposure Condition | Active comparator | Behavioral: Imagination ExposureParticipants 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. |
| Arm 2: Non-immersive Virtual Reality Exposure Condition | Experimental | Device: Non-immersive Virtual Reality ExposureParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults individuals from general population.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imagination ExposureAlso: IE, Imagination-based ExposureParticipants 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. | Behavioural | Arm 1: Imagination Exposure Condition |
| Non-immersive Virtual Reality ExposureAlso: VRE, Virtual Reality Exposure, Computer-based VRParticipants 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. | Device | Arm 2: Non-immersive Virtual Reality Exposure Condition |
Primary outcome
Change in State Anxiety as measured by the State-Trait Anxiety Inventory (Y)- State subscale
Time frame: Baseline (immediately before the intervention) and Post-intervention (immediately after completion of the single experimental session).
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.
Change in Positive and Negative Affect as measured by the Positive and Negative Affect Schedule (PANAS)
Time frame: Baseline (immediately before the intervention) and Post-intervention (immediately after completion of the single experimental session).
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.
Frequency of Discarding Behavior (Behavioral Observation)
Time frame: During the single experimental session (immediately after intervention).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Derived from this study: PubMed 41024139Pardini S, Olivetto S, Martinelli M, Novara C. Non-immersive virtual environments for the treatment of hoarding disorder: a preliminary randomized controlled trial based on a non-clinical sample. BMC Psychol. 2025 Sep 29;13(1):1078. doi: 10.1186/s40359-025-03446-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caterina Novara, PhD principal investigator
University of Padova
Susanna Pardini, PhD principal investigator
Centre for Digital Health and Well-being, Fondazione Bruno Kessler, Trento, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imagination Exposure and Non-immersive Virtual Reality Exposure in people with Hoarding Disorder and Virtual Reality Based Therapy, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in State Anxiety as measured by the State-Trait Anxiety Inventory (Y)- State subscale (time frame: Baseline (immediately before the intervention) and Post-intervention (immediately after completion of the single experimental session).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07160543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.