Anorexia NervosaNCT04028635
Treating the Fear of Gaining Weight in Anorexia Nervosa
A study testing Cognitive-behavioral therapy plus VR-based body exposure and Cognitive behavioral therapy in people with Anorexia Nervosa, run by University of Barcelona at 1 site in Spain.
Trial summary
The main aim of this study is to develop a virtual reality (VR) embodiment-based exposure technique to improve the treatment of anorexia nervosa (AN). A systematic and hierarchical body exposure intervention in which the patient owns a virtual avatar is proposed. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Cognitive-behavioral therapy plus VR-based body exposure and Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 25 Feb 2019to 30 Jul 2020
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with primary diagnosis of anorexia nervosa (DSM-V)
- from the age of 14 years
- with BMI <18.5
Who cannot join
- visual deficits
- epilepsy or neuroleptic medication
- psychotic disorder
- bipolar disorder
- medical complications
- pregnancy
- clinical cardiac arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treating the Fear of Gaining Weight. A Randomized Controlled Clinical Trial for Patients With Anorexia Nervosa
The main aim of this study is to develop a virtual reality (VR) embodiment-based exposure technique to improve the treatment of anorexia nervosa (AN). A systematic and hierarchical body exposure intervention in which the patient owns a virtual avatar is proposed. At first, the virtual body matches with the real measurements of the patient, then the experimenter will progressively increase Body Mass Index (BMI) values of the virtual body during the exposure sessions until a healthy BMI value is reached (e.g. BMI score of 20). In this study a VR embodiment-based technique that combines visuo-motor and a visuo-tactile stimulation procedures is proposed in order to increase illusory feelings of ownership over the virtual body. It is hypothesised that adding a VR-based body exposure intervention to the classical cognitive behavioral therapy (CBT) will significantly reduce symptomatology in AN patients.
Read the detailed description
In order to evaluate the efficacy of the addition of a VR body exposure component to the usual treatment, a randomized controlled clinical trial will be conducted. 54 patients with a primary diagnosis of anorexia nervosa and a BMI > 18.5 will be randomly assigned to the experimental group receiving VR body exposure in addition to cognitive behavioral therapy or control group, which receives cognitive behavioral therapy only. Data regarding eating disorder symptomatology and body related attention will be collected before and at the end of the intervention, as well as after six months of follow-up. In the systematic and hierarchical VR body exposure intervention, which consists of 5 weekly exposure sessions, patients will gradually be exposed to increases in the BMI of their virtual avatar. Each session starts by inducing illusory feelings of ownership over the virtual body by the means of visuo-tactile and visuo-motor stimulation. Then patients are exposed to their virtual bodies in order to achieve the habituation or extinction of the anxiety response to their body image and, consequently, reduce the fear of gaining weight. During exposure, patients will be asked to focus on different parts of the virtual body, by asking what they think and feel about them. Body ownership illusion, body-related anxiety and fear of gaining weight will be assessed within each session by means of visual analogue scales.
- Conditions
- Anorexia Nervosa
- Being tested
- Cognitive-behavioral therapy plus VR-based body exposure, Cognitive behavioral therapy
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapy plus VR-based body exposureBehavioural
Combine usual cognitive-behavioral treatment (CBT) sessions with additional five VR-based body-exposure therapy sessions.
Cognitive behavioral therapyBehavioural
Usual CBT
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-behavioral therapy plus VR-based body exposure | Experimental | Patients assigned to this group will receive the usual CBT from the clinical unit or the hospital where they are, and additionally, six sessions of VR-based body exposure intervention. In these weekly sessions patients will go through a body exposure intervention in which the they will own a virtual avatar with their real measurements, that will progressively increase its BMI values throughout the following exposure sessions, until a healthy BMI value is reached. Receives: Behavioral: Cognitive-behavioral therapy plus VR-based body exposure |
| Cognitive behavioral therapy | Active comparator | Patients assigned to this group will receive the usual treatment from the centre in which they are recruited for the study (CBT), and will have to complete the evaluations following the same schedule as the experimental group. Receives: Behavioral: Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index
Evaluation of change in Body Mass Index
Measured: from pre-assessment to post-assessment after 6 weeks
Change in Eating Disorders Inventory-3 (EDI-3) drive for thinness (EDI-DT) scale
Evaluation of the change in drive for thinness, with maximum possible score of 28, where higher scores indicate higher drive for thinness
Measured: from pre-assessment to post-assessment after 6 weeks
Change in Eating Disorders Inventory-3 (EDI-3) body dissatisfaction (EDI-BD) scale
Evaluation of the change in body dissatisfaction, with maximum possible score of 40, where higher scores indicate higher body dissatisfaction
Measured: from pre-assessment to post-assessment after 6 weeks
Change in Silhouette Test for Adolescents (TSA) body distortion scores
Evaluation of the change in body distortion in adolescents using the TSA body distortion scores, which can range from -3 to 3, with higher values indicating higher body distortion
Measured: from pre-assessment to post-assessment after 6 weeks
Change in Silhouette Test for Adolescents (TSA) body dissatisfaction scores
Evaluation of the change in body dissatisfaction in adolescents using the TSA body dissatisfaction scores, which can range from -3 to 3, with lower scores indicating higher body dissatisfaction
Measured: from pre-assessment to post-assessment after 6 weeks
Figural Drawing Scale for Body Image Assessment (BIAS-BD) body distortion scores
Evaluation of the change in body distortion in adults using the BIAS-BD body distortion scores, ranging from -80 to 80, with higher scores indicating higher body distortion
Measured: from pre-assessment to post-assessment after 6 weeks
Figural Drawing Scale for Body Image Assessment (BIAS-BD) body dissatisfaction scores
Evaluation of the change in body dissatisfaction in adults using the BIAS-BD body dissatisfaction scores, ranging from -80 to 80, with higher scores indicating higher body dissatisfaction
Measured: from pre-assessment to post-assessment after 6 weeks
Change in Physical Appearance State Anxiety Scale (PASTAS)
Evaluation of body-related anxiety using the PASTAS, with a maximum score of 32, with higher scores indicating higher body-related anxiety
Measured: from pre-assessment to post-assessment after 6 weeks
Change in Body Appreciation Scale (BAS)
Evaluation of the change in body appreciation using the BAS, with a scale of possible scores ranging from 13-65, where higher scores indicate higher body appreciation
Measured: from pre-assessment to post-assessment after 6 weeks
Secondary outcomes (2)
Change in complete fixation time of the gaze towards weight-related body parts
Evaluation of the attentional bias towards the body using complete fixation time (evaluated in milliseconds) of the gaze towards weight-related body parts, with higher values indicating a greater attentional bias
Measured: from pre-assessment to post-assessment after 6 weeks
Change in number of fixations of the gaze towards weight-related body parts
Evaluation of the attentional bias towards the body using the number of fixations of the gaze towards weight-related body parts, with higher values indicating a greater attentional bias
Measured: from pre-assessment to post-assessment after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start25 Feb 2019
- Primary completion30 Apr 2020
- Study completion30 Jul 2020
Why it stopped: The study was terminated with a total of 35 patients finally enrolled, due to the Sars-Cov-2 (COVID-19) global pandemic breakout and the confinement measures considered.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sant Joan de Deu, Hospital Clinic of Barcelona, Hospital San Carlos, Madrid, Hospital Universitari de Bellvitge, Istituto Auxologico Italiano
- Responsible party
- Principal investigator, Jose Gutierrez Maldonado, University of Barcelona
- Investigators
- José Gutiérrez-Maldonado, Prof. Dr., Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028635
- Sponsor's protocol ID
- PSI2015-70389-R
- Status last verified
- Nov 2020
- First submitted
- 16 Jul 2019
- Last updated
- 17 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating the Fear of Gaining Weight. A Randomized Controlled Clinical Trial for Patients With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT04028635
- Acronym / sponsor ID
- PSI2015-70389-R
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated with a total of 35 patients finally enrolled, due to the Sars-Cov-2 (COVID-19) global pandemic breakout and the confinement measures considered.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- Hospital Sant Joan de Deu, Hospital Clinic of Barcelona, Hospital San Carlos, Madrid, Hospital Universitari de Bellvitge, Istituto Auxologico Italiano
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 22 Jul 2019 (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.
The main aim of this study is to develop a virtual reality (VR) embodiment-based exposure technique to improve the treatment of anorexia nervosa (AN). A systematic and hierarchical body exposure intervention in which the patient owns a virtual avatar is proposed. At first, the virtual body matches with the real measurements of the patient, then the experimenter will progressively increase Body Mass Index (BMI) values of the virtual body during the exposure sessions until a healthy BMI value is reached (e.g. BMI score of 20). In this study a VR embodiment-based technique that combines visuo-motor and a visuo-tactile stimulation procedures is proposed in order to increase illusory feelings of ownership over the virtual body. It is hypothesised that adding a VR-based body exposure intervention to the classical cognitive behavioral therapy (CBT) will significantly reduce symptomatology in AN patients.
Detailed description
In order to evaluate the efficacy of the addition of a VR body exposure component to the usual treatment, a randomized controlled clinical trial will be conducted. 54 patients with a primary diagnosis of anorexia nervosa and a BMI > 18.5 will be randomly assigned to the experimental group receiving VR body exposure in addition to cognitive behavioral therapy or control group, which receives cognitive behavioral therapy only. Data regarding eating disorder symptomatology and body related attention will be collected before and at the end of the intervention, as well as after six months of follow-up. In the systematic and hierarchical VR body exposure intervention, which consists of 5 weekly exposure sessions, patients will gradually be exposed to increases in the BMI of their virtual avatar. Each session starts by inducing illusory feelings of ownership over the virtual body by the means of visuo-tactile and visuo-motor stimulation. Then patients are exposed to their virtual bodies in order to achieve the habituation or extinction of the anxiety response to their body image and, consequently, reduce the fear of gaining weight. During exposure, patients will be asked to focus on different parts of the virtual body, by asking what they think and feel about them. Body ownership illusion, body-related anxiety and fear of gaining weight will be assessed within each session by means of visual analogue scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioral therapy plus VR-based body exposure | Experimental | Behavioral: Cognitive-behavioral therapy plus VR-based body exposurePatients assigned to this group will receive the usual CBT from the clinical unit or the hospital where they are, and additionally, six sessions of VR-based body exposure intervention. In these weekly sessions patients will go through a body exposure intervention in which the they will own a virtual avatar with their real measurements, that will progressively increase its BMI values throughout the following exposure sessions, until a healthy BMI value is reached. |
| Cognitive behavioral therapy | Active comparator | Behavioral: Cognitive behavioral therapyPatients assigned to this group will receive the usual treatment from the centre in which they are recruited for the study (CBT), and will have to complete the evaluations following the same schedule as the experimental group. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients with primary diagnosis of anorexia nervosa (DSM-V)
- from the age of 14 years
- with BMI <18.5
Key exclusion criteria (7 listed)
- visual deficits
- epilepsy or neuroleptic medication
- psychotic disorder
- bipolar disorder
- medical complications
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 |
|---|---|---|
| Cognitive-behavioral therapy plus VR-based body exposureCombine usual cognitive-behavioral treatment (CBT) sessions with additional five VR-based body-exposure therapy sessions. | Behavioural | Cognitive-behavioral therapy plus VR-based body exposure |
| Cognitive behavioral therapyUsual CBT | Behavioural | Cognitive behavioral therapy |
Primary outcome
Change in Body Mass Index
Time frame: from pre-assessment to post-assessment after 6 weeks
Evaluation of change in Body Mass Index
Change in Eating Disorders Inventory-3 (EDI-3) drive for thinness (EDI-DT) scale
Time frame: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in drive for thinness, with maximum possible score of 28, where higher scores indicate higher drive for thinness
Change in Eating Disorders Inventory-3 (EDI-3) body dissatisfaction (EDI-BD) scale
Time frame: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in body dissatisfaction, with maximum possible score of 40, where higher scores indicate higher body dissatisfaction
Change in Silhouette Test for Adolescents (TSA) body distortion scores
Time frame: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in body distortion in adolescents using the TSA body distortion scores, which can range from -3 to 3, with higher values indicating higher body distortion
Change in Silhouette Test for Adolescents (TSA) body dissatisfaction scores
Time frame: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in body dissatisfaction in adolescents using the TSA body dissatisfaction scores, which can range from -3 to 3, with lower scores indicating higher body dissatisfaction
Figural Drawing Scale for Body Image Assessment (BIAS-BD) body distortion scores
Time frame: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in body distortion in adults using the BIAS-BD body distortion scores, ranging from -80 to 80, with higher scores indicating higher body distortion
Figural Drawing Scale for Body Image Assessment (BIAS-BD) body dissatisfaction scores
Time frame: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in body dissatisfaction in adults using the BIAS-BD body dissatisfaction scores, ranging from -80 to 80, with higher scores indicating higher body dissatisfaction
Change in Physical Appearance State Anxiety Scale (PASTAS)
Time frame: from pre-assessment to post-assessment after 6 weeks
Evaluation of body-related anxiety using the PASTAS, with a maximum score of 32, with higher scores indicating higher body-related anxiety
Change in Body Appreciation Scale (BAS)
Time frame: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in body appreciation using the BAS, with a scale of possible scores ranging from 13-65, where higher scores indicate higher body appreciation
2 secondary outcomes
Change in complete fixation time of the gaze towards weight-related body parts
Time frame: from pre-assessment to post-assessment after 6 weeks
Change in number of fixations of the gaze towards weight-related body parts
Time frame: from pre-assessment to post-assessment after 6 weeks
Results and safety
The study was stopped early (reason given: The study was terminated with a total of 35 patients finally enrolled, due to the Sars-Cov-2 (COVID-19) global pandemic breakout and the confinement measures considered.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
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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.
José Gutiérrez-Maldonado, Prof. Dr. principal investigator
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral therapy plus VR-based body exposure and Cognitive behavioral therapy in people with Anorexia Nervosa, run by University of Barcelona at 1 site in Spain.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 17 Nov 2020. 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 Spain. 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 was stopped early (reason given: The study was terminated with a total of 35 patients finally enrolled, due to the Sars-Cov-2 (COVID-19) global pandemic breakout and the confinement measures considered.). Results are not available in the source record.
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 Body Mass Index (time frame: from pre-assessment to post-assessment after 6 weeks). The study lists 9 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 17 Nov 2020.