Anorexia NervosaVR-FMENCT06852183
Restructuring Body Experience in Anorexia Nervosa: Virtual Reality Functionality-Focused Mirror Exposure
A study testing VR -FME in people with Anorexia Nervosa, run by Catholic University of the Sacred Heart.
Trial summary
Background: Body image disturbance remains a core therapeutic challenge in Anorexia Nervosa (AN) treatment, necessitating innovative intervention approaches. This study protocol describes a randomized controlled trial investigating Virtual Reality Functionality-Focused Mirror Exposure (VR-FME), a novel intervention… Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- VR -FME
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: between 16-24.
- Primary diagnosis of Anorexia Nervosa
- BMI > 14.5
- No current diagnosis or previous diagnosis for neurological disorders
- Females
- Fluency in Italian
- Ability to provide informed consent (and parental consent for minors)
Who cannot join
- Anorexia Nervosa is not a primary diagnosis
- Age < 16
- BMI < 14.5
- Conditions that could interfere with VR use (e.g., neurological conditions, severe visual impairments, vestibular disorders)
- Males
- Substance abuse, active suicidal ideation, severe psychiatric comorbidities
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- Pregrancy
- Ongoing participation in other clinical trials
- Inability to commit to the full duration of the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Background: Body image disturbance remains a core therapeutic challenge in Anorexia Nervosa (AN) treatment, necessitating innovative intervention approaches. This study protocol describes a randomized controlled trial investigating Virtual Reality Functionality-Focused Mirror Exposure (VR-FME), a novel intervention targeting the perceptual, affective, and cognitive dimensions of body image disturbance in AN patients.
Methods: This single-blind, parallel-group randomized controlled trial will evaluate the efficacy of VR-FME as an adjunct to treatment as usual (TAU). Participants with AN will be randomly allocated to receive either VR-FME combined with TAU or TAU alone. The intervention specifically addresses altered body image through immersive virtual reality technology, providing controlled exposure and cognitive restructuring opportunities.
Read more
Primary Outcome: The primary outcome measure will assess changes in body image disturbance severity and core eating disorder symptomatology. We hypothesize that the integration of VR-FME with TAU will demonstrate superior therapeutic outcomes compared to TAU alone.
Significance: This protocol represents an innovative approach to addressing body image disturbance in AN, potentially enhancing current therapeutic strategies through the integration of immersive virtual reality technology. The findings will contribute to the evolving landscape of technology-enhanced interventions for eating disorders.
- Conditions
- Anorexia Nervosa
- Being tested
- VR -FME
- Keywords
- Virtual Reality, Multisensory Integration, Anorexia Nervosa, Body Image
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR -FMEOther
The VR-FME intervention specifically focuses on improving body representation and the body-self relationship by working on multisensory integration processes and embodied cognition techniques. This is thanks to the combination of immersive virtual reality experiences of body illusion combined with traditional psychological techniques. The experimental group will receive this intervention in addition to the usual treatment, which will continue as usual for the control group. The intervention consists of 8 sessions spread over 4 weeks, with 2 sessions per week.
| Study group | Role | What they receive |
|---|---|---|
| VR-FME | Experimental | The VR-FME protocol integrates multiple therapeutic approaches within an immersive virtual environment. Each 60-minute session begins with embodiment induction, where participants experience synchronized multisensory stimulation to create embodiment over their virtual body. Then, various therapeutic techniques - including cognitive dissonance mirror exposure, functionality-focused mirror exposure, and compassionate body scan exercises - will be used. Each of the 8 sessions will work on a specific aspect to address different levels of body image disturbance. The intervention structure begins with an initial assessment and familiarization phase in Week 1, followed by intensive body-focused work in Weeks 2-4. Receives: Other: VR -FME |
| TAU | Active comparator | For the entire duration of the protocol, both the experimental group (VR-FME) and the control groups will carry out the standard intervention protocol proposed by the treatment center, which consists of an outpatient program that includes weekly internal-nutritional visits, psychotherapy and NPIA assessments to also monitor the pharmacological therapy. Therefore, if the experimental group carries out the standard procedure (Treatment As Usual - TAU) in addition to the VR body image protocol (VR-FME + TAU), the control group will be subjected to the standard treatment path (TAU). Receives: Other: VR -FME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Inventory 3
Eating Disorder Inventory 3 (EDI-3): The EDI-3 is a widely used self-report and standardized measure to assess symptomatology and psychological features relevant to developing and maintaining EDs. The third version (EDI-3) includes 91 items classified into 12 scales, with a six-point Likert scale for each answer ranging from 0 (never) to 5 (always).
Measured: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Physical Appearance State and Trait Anxiety Scale
Physical Appearance State and Trait Anxiety Scale (PASTAS): The PASTAS is a reliable and valid measure for the assessment of trait and state body image anxiety. Patients had to rate, on a five-point scale ranging from 0 (never) to 5 (always), if they felt anxious or nervous about their physical appearance, including any tension, negative thoughts, and physiological responses. This tool has been previously used in research studies including Italian samples.
Measured: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Body Mass Index
Body Mass Index (BMI)
Measured: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Body Image Assessment Scale - Body Dimensions
The Body Image Assessment Scale-Body Dimensions (BIAS-BD): The BIAS-BD is used to assess the perceptual and emotional components of BIDs. This test assesses the discrepancy between the perceived body size and the self-determined ideal body size (to measure body dissatisfaction). Furthermore, it also reveals the discrepancy between the perceived body size and the real body size (to measure body distortion). The scale presents a range of 17 silhouettes, with different versions for women and me
Measured: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Body Size Estimation Task
Body Size Estimation Task (BES): it is a behavioral task in which participants are asked to estimate the measure of specific body parts (i.e., shoulders, hips, and waist).
Measured: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Body Appreciation Scale-2
Body Appreciation Scale-2 (BAS-2): The BAS-2 is a 10-item measure assessing body appreciation. Participants rate statements on Likert-type scales from 1 (never) to 5 (always). Items are averaged; higher scores indicate greater body appreciation. Example items include: "I respect my body"; "I take a positive attitude towards my body"; and "I am comfortable in my body". This tool has been validated in Italian.
Measured: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Objectified Body Consciousness Scale
Objectified Body Consciousness Scale (OBCS): The OBCS contains 24 items grouped into three subscales: body surveillance, body shame, and appearance control beliefs. Each subscale contains eight items, rated on a 7- 7-point Likert-type scale (1 =strongly disagree, 7 = strongly agree). Subscale items are averaged and higher scores indicate a greater manifestation of the particular variable measured. This tool has been validated in Italian.
Measured: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Body Uneasiness Test
Body Uneasiness Test (BUT): The BUT is a 34-item self-report questionnaire focusing on body dissatisfaction and body-related emotions such as anxiety, alarm, and embarrassment. It is composed of five subscales - weight phobia, body image concern, avoidance, compulsive self-monitoring, depersonalization - and a general score. This tool has been validated in Italian.
Measured: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Secondary outcomes (1)
Qualitative feedback survey
Qualitative feedback from participants
Measured: After the end of the intervention (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Fatebenefratelli Hospital, Centro ABA Fatebenefratelli
- Responsible party
- Principal investigator, Giulia Brizzi, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852183
- Sponsor's protocol ID
- CNR_08/2024
- Acronym
- VR-FME
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restructuring Body Experience in Anorexia Nervosa: Virtual Reality Functionality-Focused Mirror Exposure
- ClinicalTrials.gov ID
- NCT06852183
- Acronym / sponsor ID
- VR-FME / CNR_08/2024
- Conditions
- Anorexia Nervosa
- Keywords
- Virtual Reality, Multisensory Integration, Anorexia Nervosa, Body Image
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Fatebenefratelli Hospital, Centro ABA Fatebenefratelli
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Feb 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.
Background: Body image disturbance remains a core therapeutic challenge in Anorexia Nervosa (AN) treatment, necessitating innovative intervention approaches. This study protocol describes a randomized controlled trial investigating Virtual Reality Functionality-Focused Mirror Exposure (VR-FME), a novel intervention targeting the perceptual, affective, and cognitive dimensions of body image disturbance in AN patients.
Methods: This single-blind, parallel-group randomized controlled trial will evaluate the efficacy of VR-FME as an adjunct to treatment as usual (TAU). Participants with AN will be randomly allocated to receive either VR-FME combined with TAU or TAU alone. The intervention specifically addresses altered body image through immersive virtual reality technology, providing controlled exposure and cognitive restructuring opportunities.
Primary Outcome: The primary outcome measure will assess changes in body image disturbance severity and core eating disorder symptomatology. We hypothesize that the integration of VR-FME with TAU will demonstrate superior therapeutic outcomes compared to TAU alone.
Significance: This protocol represents an innovative approach to addressing body image disturbance in AN, potentially enhancing current therapeutic strategies through the integration of immersive virtual reality technology. The findings will contribute to the evolving landscape of technology-enhanced interventions for eating disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-FME | Experimental | Other: VR -FMEThe VR-FME protocol integrates multiple therapeutic approaches within an immersive virtual environment. Each 60-minute session begins with embodiment induction, where participants experience synchronized multisensory stimulation to create embodiment over their virtual body. Then, various therapeutic techniques - including cognitive dissonance mirror exposure, functionality-focused mirror exposure, and compassionate body scan exercises - will be used. Each of the 8 sessions will work on a specific aspect to address different levels of body image disturbance. The intervention structure begins with an initial assessment and familiarization phase in Week 1, followed by intensive body-focused work in Weeks 2-4. |
| TAU | Active comparator | Other: VR -FMEFor the entire duration of the protocol, both the experimental group (VR-FME) and the control groups will carry out the standard intervention protocol proposed by the treatment center, which consists of an outpatient program that includes weekly internal-nutritional visits, psychotherapy and NPIA assessments to also monitor the pharmacological therapy. Therefore, if the experimental group carries out the standard procedure (Treatment As Usual - TAU) in addition to the VR body image protocol (VR-FME + TAU), the control group will be subjected to the standard treatment path (TAU). |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age: between 16-24.
- Primary diagnosis of Anorexia Nervosa
- BMI > 14.5
- No current diagnosis or previous diagnosis for neurological disorders
- Females
Key exclusion criteria (9 listed)
- Anorexia Nervosa is not a primary diagnosis
- Age < 16
- BMI < 14.5
- Conditions that could interfere with VR use (e.g., neurological conditions, severe visual impairments, vestibular disorders)
- Males
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 |
|---|---|---|
| VR -FMEThe VR-FME intervention specifically focuses on improving body representation and the body-self relationship by working on multisensory integration processes and embodied cognition techniques. This is thanks to the combination of immersive virtual reality experiences of body illusion combined with traditional psychological techniques. The experimental group will receive this intervention in addition to the usual treatment, which will continue as usual for the control group. The intervention consists of 8 sessions spread over 4 weeks, with 2 sessions per week. | Other | TAU, VR-FME |
Primary outcome
Eating Disorder Inventory 3
Time frame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Eating Disorder Inventory 3 (EDI-3): The EDI-3 is a widely used self-report and standardized measure to assess symptomatology and psychological features relevant to developing and maintaining EDs. The third version (EDI-3) includes 91 items classified into 12 scales, with a six-point Likert scale for each answer ranging from 0 (never) to 5 (always).
Physical Appearance State and Trait Anxiety Scale
Time frame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Physical Appearance State and Trait Anxiety Scale (PASTAS): The PASTAS is a reliable and valid measure for the assessment of trait and state body image anxiety. Patients had to rate, on a five-point scale ranging from 0 (never) to 5 (always), if they felt anxious or nervous about their physical appearance, including any tension, negative thoughts, and physiological responses. This tool has been previously used in research studies including Italian samples.
Body Mass Index
Time frame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Body Mass Index (BMI)
Body Image Assessment Scale - Body Dimensions
Time frame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
The Body Image Assessment Scale-Body Dimensions (BIAS-BD): The BIAS-BD is used to assess the perceptual and emotional components of BIDs. This test assesses the discrepancy between the perceived body size and the self-determined ideal body size (to measure body dissatisfaction). Furthermore, it also reveals the discrepancy between the perceived body size and the real body size (to measure body distortion). The scale presents a range of 17 silhouettes, with different versions for women and me
Body Size Estimation Task
Time frame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Body Size Estimation Task (BES): it is a behavioral task in which participants are asked to estimate the measure of specific body parts (i.e., shoulders, hips, and waist).
Body Appreciation Scale-2
Time frame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Body Appreciation Scale-2 (BAS-2): The BAS-2 is a 10-item measure assessing body appreciation. Participants rate statements on Likert-type scales from 1 (never) to 5 (always). Items are averaged; higher scores indicate greater body appreciation. Example items include: "I respect my body"; "I take a positive attitude towards my body"; and "I am comfortable in my body". This tool has been validated in Italian.
Objectified Body Consciousness Scale
Time frame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Objectified Body Consciousness Scale (OBCS): The OBCS contains 24 items grouped into three subscales: body surveillance, body shame, and appearance control beliefs. Each subscale contains eight items, rated on a 7- 7-point Likert-type scale (1 =strongly disagree, 7 = strongly agree). Subscale items are averaged and higher scores indicate a greater manifestation of the particular variable measured. This tool has been validated in Italian.
Body Uneasiness Test
Time frame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Body Uneasiness Test (BUT): The BUT is a 34-item self-report questionnaire focusing on body dissatisfaction and body-related emotions such as anxiety, alarm, and embarrassment. It is composed of five subscales - weight phobia, body image concern, avoidance, compulsive self-monitoring, depersonalization - and a general score. This tool has been validated in Italian.
1 secondary outcome
Qualitative feedback survey
Time frame: After the end of the intervention (week 4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing VR -FME in people with Anorexia Nervosa, run by Catholic University of the Sacred Heart.
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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giulia Brizzi, MSC (+39 3758126821, giulia.brizzi@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Inventory 3 (time frame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2025.