A Mobile-App Training to Reduce Body Image Disorder Symptoms and Associated Features in Female University Students

Study Overview
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Brief Summary
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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).

Official Title
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A Mobile-App Training to Reduce Body Image Disorder Symptoms and Associated Psychological Features in Female University Students: A Randomized Controlled Pilot Study With Crossover Design

Conditions
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Body Image Disorder, Body Dysmorphic Disorders, Eating Disorders

Intervention / Treatment
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* Device: GGBI: Positive Body Image (Mobile App)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of Body Image Disorder symptoms Exclusion Criteria: Presence of a full-blown Body Image Disorder Presence of a psychotic/schizophrenic disorder Current treatment for a Body Image Disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immediate-use App group (iApp group)<br>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)<br>* Brief, game-like, training exercise for challenging body image disorder symptoms and associated psychological features<br>|
| Active Comparator: delayed-use App group (dApp)<br>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)<br>* Brief, game-like, training exercise for challenging body image disorder symptoms and associated psychological features<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 16 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 16 days |