The Effect of Mood Induction in Body Image Through Virtual Reality (EMOTION)

• ClinicalTrials.gov Identifier: NCT04617886
• Recruitment Status: Recruiting
• First Posted: November 5, 2020
• Last Update Posted: October 15, 2021
• Sponsor: University of Valencia
• Information provided by (Responsible Party): University of Valencia

Study Description

Brief Summary:

The effect of emotional induction of sadness (vs. joy) on the mental representation of the body image through the virtual reality

Condition or disease	Intervention/treatment	Phase
Sadness; Happiness	Other: Sadness induction; Other: Happiness induction	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Within subjects design. Each participant will be tested, in a counterbalanced way, through both (sadness vs. joy) conditions
• Masking: Single (Participant)
• Primary Purpose: Screening
• Official Title: The Effect of Mood Induction Procedure of Sadness (vs. Joy) in Body Image Through Virtual Reality
• Actual Study Start Date: November 16, 2020
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sadness condition	Other: Sadness induction; 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.; Other: Happiness induction; 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.
Experimental: Happiness condition	Other: Sadness induction; 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.; Other: Happiness induction; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

2. 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.

Secondary Outcome Measures :

1. Change in the Positive and negative affect [ Time Frame: Baseline; inmediately after procedure ]
   (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.

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 40 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria for the GENERAL population:

• BDI-II - depression symptomatology scores <14 (for ethical reasons)
• BSQ - body dissatisfaction scores > 80 (mild or more body dissatisfaction according to Cooper & Taylor, 1988)
• Age between 18 and 40

Exclusion Criteria for the GENERAL population:

• being currently under psychological treatment due to an Eating Disorder diagnosis
• having a clinical history of eating disorders
• suicide risk: BDI-II item 9 ≥ 1
• present any medical illness or physical incapacity that could impede the experiment
• Body Mass Index > 28
• pregnancy

Inclusion Criteria for CLINICAL population:

• ED diagnosis: Anorexia Nervosa, Bulimia Nervosa or Eating Disorder Not Otherwise Specified
• BDI-II - depression symptomatology scores <29 (for ethical reasons)
• Age between 14 and 18

Exclusion Criteria for CLINICAL population:

• 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 > 28
• pregnancy

Contacts and Locations

Contacts

Contact: Diana Burychka, PhD student; 963543753; diana.burychka@uv.es

Locations

Spain

University of Valencia; Recruiting

Valencia, Spain, 46010

Contact: Diana Burychka, PhD candidate diana.burychka@uv.es

Sub-Investigator: Diana Burychka, PhD candidate

Sponsors and Collaborators

University of Valencia

More Information

• Responsible Party: University of Valencia
• ClinicalTrials.gov Identifier: NCT04617886
• Other Study ID Numbers: 1127840
• First Posted: November 5, 2020
• Last Update Posted: October 15, 2021
• Last Verified: September 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No