SadnessEMOTIONNCT04617886
The Effect of Mood Induction in Body Image Through Virtual Reality
A study testing Sadness induction and Happiness induction in people with Sadness and Happiness, run by University of Valencia at 1 site in Spain.
Trial summary
The effect of emotional induction of sadness (vs. joy) on the mental representation of the body image through the virtual reality Read more about this study
- Who is it for?
- Ages 13 to 18 years, women onlyHealthy volunteers can take part
- What is being tested?
- Sadness induction and Happiness induction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 16 Nov 2020to 31 Dec 2022
- 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 13 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ED diagnosis: Anorexia Nervosa, Bulimia Nervosa or Eating Disorder Not Otherwise Specified
- BDI-II - depression symptomatology scores <29 (for ethical reasons)
- Age between 13 and 18
Who cannot join
- suicide risk: the decision of the psychiatrist/psychologist
- present any medical illness or physical incapacity that could impede the experiment
- diagnosis of Binge Eating Disorder
- Body Mass Index <14 or > 28
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mood Induction Procedure of Sadness (vs. Joy) in Body Image Through Virtual Reality
The effect of emotional induction of sadness (vs. joy) on the mental representation of the body image through the virtual reality
Read the detailed description
The general objective of this study is to analyze the impact of emotional induction (sadness vs. joy) on the two dimensions (perceptive and affective) of body image with the help of virtual reality. Thus, it is hypothesized that a negative emotional induction may partially explain the change in body image measures.
- Being tested
- Sadness induction, Happiness induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sadness inductionOther
Sadness state will be induced with a Virtual Reality program. Mood induction will be done with an emotional induction procedure in virtual reality (Mood induction parks (Baños et al., 2006)). This technique has proven to be effective in previous studies (e.g., van Strien et al. 2013). Virtual reality software simulates an urban park and includes several methods of sadness induction: Velten's tasks (1968) (sentence formulations with negative content about the self; for example, "I am not valuable", "I see no future"); visualization of a image bank with emotional content from the international system of emotional images (IAPS, Lang et al.,1999); listening to a piece of music and viewing a film scene that demonstrated his effectiveness in inducing positive affect (Donen et al. 1952; Eich and Metcalfe 1989; Gross and Levenson 1995), and an autobiographical memory test.
Happiness inductionOther
Happiness state will be induced with a Virtual Reality program. Mood induction will be done with an emotional induction procedure in virtual reality (Mood induction parks (Baños et al., 2006)). This technique has proven to be effective in previous studies (e.g., van Strien et al. 2013). Virtual reality software simulates an urban park and includes several methods of sadness induction: Velten's tasks (1968) (sentence formulations with negative content about the self; for example, "I am not valuable", "I see no future"); visualization of a image bank with emotional content from the international system of emotional images (IAPS, Lang et al.,1999); listening to a piece of music and viewing a film scene that demonstrated his effectiveness in inducing positive affect (Donen et al. 1952; Eich and Metcalfe 1989; Gross and Levenson 1995), and an autobiographical memory test.
| Study group | Role | What they receive |
|---|---|---|
| Sadness condition | Experimental | Not described Receives: Other: Sadness induction; Other: Happiness induction |
| Happiness condition | Experimental | Not described Receives: Other: Sadness induction; Other: Happiness induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Body image dissatisfaction state
Body Image States Scale (BISS; Cash, Fleming, Alindogan, Steadman y Whitehead, 2002).
This is a 6-item self-report questionnaire that measures the individuals' evaluation and affect about their physical appearance (e.g., body image appraisal and satisfaction, as well as emotional experiences) at a particular moment in time: (1) satisfaction with one's overall physical appearance, (2) satisfaction with one's body size and shape, (3) satisfaction with one's weight; (4) feelings of physical attractiveness; (5) current feelings about one's looks relative to how one usually feels; and (6) evaluation of one's appearance relative to how the average person looks. Items are rated on a 9-point bipolar Likert scale. The measure is the composite mean of the items, and higher scores reflect a more favorable body image satisfaction state. The BISS was acceptably internally consistent in the original validation. A Spanish version was translated by the authors of the study.
Measured: Baseline; inmediately after procedure
Change in the Body image estimation
Software Cognitive (developed at the lab) measuring real and ideal body size estimation based on Glendhill et al. (2017) and using Virtual Reality. The results will be reflected as Body Mass Index change (estimation of the own body size and the ideal body size in BMI).
In the present study, a total of 31 female avatars with different BMI were developed.
The VR evaluation program allowed for tasks to be performed to estimate the body size (for one's own body and for the ideal body). The body size estimation tasks consisted of two phases. In the first phase, 8 avatars with a different BMI ranging from 14.5 to 28.5 were presented randomly. Ten repetitions were performed for each avatar. In the second phase, 5 avatars were shown with a BMI greater and less in 2 units to the cut-off point estimated in the first phase of the estimation task. Five repetitions were performed for each avatar.
Measured: Baseline; inmediately after procedure
Secondary outcomes (1)
Change in the Positive and negative affect
(PANAS; Watson, Clark, and Tellegen, 1988; Spanish adaptation by López-Gómez, Hervás y Vázquez, 2015).The instrument consists of two scales: positive affection scale (PA) and negative affection scale (NA), each consisting of 10 items. The items are scored using a five-point Likert scale (1 = not at all or very slightly to 5 = very much) in the specified time period (in this study: "right now"). The total score corresponding to the presence of a specific affection, between 10 and 50, is obtained with the sum of the scores of each of the items on the scale. In the Spanish adaptation of the instrument, by López-Gómez, Hervás and Vázquez (2015), the Cronbach alpha coefficient was .92 for the PA and .88 for the AN. While the item-total correlations of the AP factor oscillate between .67 and .74, while those of the AN factor oscillate between .52 and .69.
Measured: Baseline; inmediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start16 Nov 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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 SadnessStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Within subjects design. Each participant will be tested, in a counterbalanced way, through both (sadness vs. joy) conditions
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617886
- Sponsor's protocol ID
- 1127840
- Acronym
- EMOTION
- Status last verified
- Nov 2022
- First submitted
- 23 Oct 2020
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Burychka D, Miragall M, Zapata M, Alvarez-Borillo J, Banos RM. Virtual Reality Mood Induction and Body Image Disturbance in Adolescents With Eating Disorders: An Experimental Study. Clin Psychol Psychother. 2026 Sep-Oct;33(5):e70328. doi: 10.1002/cpp.70328.
PubMed 42706768
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mood Induction Procedure of Sadness (vs. Joy) in Body Image Through Virtual Reality
- ClinicalTrials.gov ID
- NCT04617886
- Acronym / sponsor ID
- EMOTION / 1127840
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Nov 2020 (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 effect of emotional induction of sadness (vs. joy) on the mental representation of the body image through the virtual reality
Detailed description
The general objective of this study is to analyze the impact of emotional induction (sadness vs. joy) on the two dimensions (perceptive and affective) of body image with the help of virtual reality. Thus, it is hypothesized that a negative emotional induction may partially explain the change in body image measures.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Within subjects design. Each participant will be tested, in a counterbalanced way, through both (sadness vs. joy) conditions
| Arm | Type | Receives |
|---|---|---|
| Sadness condition | Experimental | Other: Sadness induction, Other: Happiness induction |
| Happiness condition | Experimental | Other: Sadness induction, Other: Happiness induction |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- ED diagnosis: Anorexia Nervosa, Bulimia Nervosa or Eating Disorder Not Otherwise Specified
- BDI-II - depression symptomatology scores <29 (for ethical reasons)
- Age between 13 and 18
Key exclusion criteria (5 listed)
- suicide risk: the decision of the psychiatrist/psychologist
- present any medical illness or physical incapacity that could impede the experiment
- diagnosis of Binge Eating Disorder
- Body Mass Index <14 or > 28
- pregnancy
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 |
|---|---|---|
| Sadness inductionSadness state will be induced with a Virtual Reality program. Mood induction will be done with an emotional induction procedure in virtual reality (Mood induction parks (Baños et al., 2006)). This technique has proven to be effective in previous studies (e.g., van Strien et al. 2013). Virtual reality software simulates an urban park and includes several methods of sadness induction: Velten's tasks (1968) (sentence formulations with negative content about the self; for example, "I am not valuable", "I see no future"); visualization of a image bank with emotional content from the international system of emotional images (IAPS, Lang et al.,1999); listening to a piece of music and viewing a film scene that demonstrated his effectiveness in inducing positive affect (Donen et al. 1952; Eich and Metcalfe 1989; Gross and Levenson 1995), and an autobiographical memory test. | Other | Happiness condition, Sadness condition |
| Happiness inductionHappiness state will be induced with a Virtual Reality program. Mood induction will be done with an emotional induction procedure in virtual reality (Mood induction parks (Baños et al., 2006)). This technique has proven to be effective in previous studies (e.g., van Strien et al. 2013). Virtual reality software simulates an urban park and includes several methods of sadness induction: Velten's tasks (1968) (sentence formulations with negative content about the self; for example, "I am not valuable", "I see no future"); visualization of a image bank with emotional content from the international system of emotional images (IAPS, Lang et al.,1999); listening to a piece of music and viewing a film scene that demonstrated his effectiveness in inducing positive affect (Donen et al. 1952; Eich and Metcalfe 1989; Gross and Levenson 1995), and an autobiographical memory test. | Other | Happiness condition, Sadness condition |
Primary outcome
Change in the Body image dissatisfaction state
Time frame: Baseline; inmediately after procedure
Body Image States Scale (BISS; Cash, Fleming, Alindogan, Steadman y Whitehead, 2002). This is a 6-item self-report questionnaire that measures the individuals' evaluation and affect about their physical appearance (e.g., body image appraisal and satisfaction, as well as emotional experiences) at a particular moment in time: (1) satisfaction with one's overall physical appearance, (2) satisfaction with one's body size and shape, (3) satisfaction with one's weight; (4) feelings of physical attractiveness; (5) current feelings about one's looks relative to how one usually feels; and (6) evaluation of one's appearance relative to how the average person looks. Items are rated on a 9-point bipolar Likert scale. The measure is the composite mean of the items, and higher scores reflect a more favorable body image satisfaction state. The BISS was acceptably internally consistent in the original validation. A Spanish version was translated by the authors of the study.
Change in the Body image estimation
Time frame: Baseline; inmediately after procedure
Software Cognitive (developed at the lab) measuring real and ideal body size estimation based on Glendhill et al. (2017) and using Virtual Reality. The results will be reflected as Body Mass Index change (estimation of the own body size and the ideal body size in BMI). In the present study, a total of 31 female avatars with different BMI were developed. The VR evaluation program allowed for tasks to be performed to estimate the body size (for one's own body and for the ideal body). The body size estimation tasks consisted of two phases. In the first phase, 8 avatars with a different BMI ranging from 14.5 to 28.5 were presented randomly. Ten repetitions were performed for each avatar. In the second phase, 5 avatars were shown with a BMI greater and less in 2 units to the cut-off point estimated in the first phase of the estimation task. Five repetitions were performed for each avatar.
1 secondary outcome
Change in the Positive and negative affect
Time frame: Baseline; inmediately after procedure
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 23 Oct 2023.
- Derived from this study: PubMed 42706768Burychka D, Miragall M, Zapata M, Alvarez-Borillo J, Banos RM. Virtual Reality Mood Induction and Body Image Disturbance in Adolescents With Eating Disorders: An Experimental Study. Clin Psychol Psychother. 2026 Sep-Oct;33(5):e70328. doi: 10.1002/cpp.70328.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sadness induction and Happiness induction in people with Sadness and Happiness, run by University of Valencia 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 5 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 23 Oct 2023. 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 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 the Body image dissatisfaction state (time frame: Baseline; inmediately after procedure). The study lists 2 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 NCT04617886, 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 23 Oct 2023.