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

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

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).

Study Overview

• Status: Completed
• Conditions: Body Image Disorder; Body Dysmorphic Disorders; Eating Disorders
• Intervention / Treatment: Device: GGBI: Positive Body Image (Mobile App)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PD
    • Padua, PD, Italy, 35131
      • University of Padua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2019
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 16, 2024
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Somatoform Disorders; Feeding and Eating Disorders; Body Dysmorphic Disorders
• Other Study ID Numbers: 2936

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No