An interventional study of GGBI: Positive Body Image (Mobile App) in Body Image Disorder, Body Dysmorphic Disorders and Eating Disorders, sponsored by University of Padova. Completed at 1 site in Italy. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by University of Padova · Not applicable, Interventional, and Prevention
Body dissatisfaction represents a prevalent condition in young women, and it is associated with low self-esteem, depression, and symptoms of Body Dysmorphic Disorder (BDD) and Eating Disorders (EDs). The aim of the trial is to test the effect of a mobile health application called "GGBI: Positive Body Image" in reducing body dissatisfaction, body dysmorphic disorder/eating disorder symptoms, and associated psychological features in female university students considered at high-risk of developing Body Image Disorders (BIDs).
Hypothesis: Participants using "GGBI: Positive Body Image" immediately following baseline assessment (Time 0; T0) (immediate-use App group: iApp) would exhibit greater reduction in body dissatisfaction, body dysmorphic disorder/eating disorder symptoms, and associated psychological features than participants who did not use "GGBI: Positive Body Image" in this phase of the study (delayed-use App group: dApp). Following crossover (Time 1; T1), the investigators expect that participants gains in the iApp group would be maintained at follow-up (Time 2; T2).
56 studies on the registry are indexed under Body Dysmorphic Disorders; 11 are open to participants now.
This study's enrollment of 100 is above the median of 52 across 44 interventional studies indexed under Body Dysmorphic Disorders.
Browse Body Dysmorphic Disorders studies →University of Padova is the lead sponsor of 215 studies on the registry; 42 are open to participants now.
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Exclusion Criteria:
Participants in the iApp group start using the app immediately (Time 0; T0) for 16 consecutive days (until Time 1; T1).
Device: GGBI: Positive Body Image (Mobile App)
Participants in the dApp group start using the app at Time 1 (T1; 16 days after the iApp group) and use the app for the following 16 days (Time 2; T2).
Device: GGBI: Positive Body Image (Mobile App)
Brief, game-like, training exercise for challenging body image disorder symptoms and associated psychological features
Change of body dissatisfaction and body dysmorphic disorder symptoms
Assessed with the Questionario sul Dismorfmismo Corporo (Questionnaire about Body Dysmorphic Disorder; QDC; Cerea et al., 2017), a self-report questionnaire assessing body dissatisfaction and body dysmorphic disorder symptoms made up of 40 items. Items are rated on a 7-point Likert scale (from 1 = strongly disagree to 7 = strongly agree; score range: 40-280), with higher scores indicating extreme body dissatisfaction and body dysmorphic disorder symptoms. Individuals who score above the cut-off of the questionnaire (QDC total score = 130) should be referred for further assessment because they might present extreme body dissatisfaction/body dysmorphic disorder symptoms or may be at risk of developing body dysmorphic disorder
Time frame: 16 days
Change of eating attitudes and behaviors
Eating Disorder Inventory-3 (EDI-3; Garner, 2004; Italian version by Giannini et al., 2008): a self-report questionnaire assessing eating disorders core features made up of 91 items on a 6-point Likert scale (from always to never), with higher scores indicating higher eating disorder symptoms. It contains three primary subscales: Drive for Thinness (score range = 0-28; higher scores indicating higher drive for thinness), Bulimia (score range = 0-32; higher scores indicating higher bulimic symptoms), and Body Dissatisfaction (score range = 0-40; higher scores indicating higher body dissatisfaction). These subscales compose the Eating Disorder Risk Composite (EDRC) score. The other nine additional scales are Low Self-Esteem, Personal Alienation, Interpersonal Insecurity, Interpersonal Alienation, Interoceptive Deficits, Emotional Dysregulation, Perfectionism, Asceticism, and Maturity Fears.
Time frame: 16 days
Change of self-esteem
Assessed with the Rosenberg Self Esteem Scale (RSES; Rosenberg, 1965; Italian version by Prezza, Trombaccia, and Armento, 1997), a self-report questionnaire assessing self-esteem. The Rosenberg Self Esteem Scale is made up of 10 items rated on a 4-point Likert scale (from 1 = "strongly disagree" to 4 = "strongly agree" ), with higher scores indicating higher self-esteem
Time frame: 16 days
Change in social anxiety symptoms
Assessed with the Social Interaction Anxiety Scale (SIAS; Mattick \& Clarke, 1998; Italian version by Sica, Musoni, Bisi, Lolli, \& Sighinolfi, 2007), a self-report questionnaire assessing social anxiety symptoms. The Social Interaction Anxiety Scale made up of 19 items on a 5-point Likert scale (from 0 = "not at all characteristic of true of me" to 4 = "extremely characteristic of true of me"; score range: 0-76); higher scores indicate higher levels of social interaction anxiety symptoms
Time frame: 16 days
Plan to share: Yes
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Ran from Jan 2019 to primary completion in Jul 2019, 6 months.
Of 26 interventional studies with no phase under Body Dysmorphic Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's 6 months is below that.
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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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