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

Eating Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04103606
• Other study ID #: 2936
• Status: Completed
• Phase: N/A
• Start date: January 30, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2022
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Dysmorphic Disorders
• Body Image Disorder
• Disease
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Device:
• GGBI: Positive Body Image (Mobile App)
Brief, game-like, training exercise for challenging body image disorder symptoms and associated psychological features

Locations

Country	Name	City	State
Italy	University of Padua	Padua	PD

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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