NCT04617886

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

November 16, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 23, 2023

Status Verified

November 1, 2022

Enrollment Period

2.1 years

First QC Date

October 23, 2020

Last Update Submit

October 19, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline; inmediately after procedure

Secondary Outcomes (1)

  • Change in the Positive and negative affect

    Baseline; inmediately after procedure

Study Arms (2)

Sadness condition

EXPERIMENTAL
Other: Sadness inductionOther: Happiness induction

Happiness condition

EXPERIMENTAL
Other: Sadness inductionOther: Happiness induction

Interventions

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 conditionSadness condition

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.

Happiness conditionSadness condition

Eligibility Criteria

Age13 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Within subjects design. Each participant will be tested, in a counterbalanced way, through both (sadness vs. joy) conditions
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2020

First Posted

November 5, 2020

Study Start

November 16, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

October 23, 2023

Record last verified: 2022-11

Locations