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Completed

NCT Number: NCT04103606

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

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).

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Key information

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Padua

Padua, PD, 35131, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GGBI: Positive Body Image (Mobile App)

Device

Brief, game-like, training exercise for challenging body image disorder symptoms and associated psychological features

Primary outcomes

  1. Change of body dissatisfaction and body dysmorphic disorder symptoms

    Time frame: 16 days

    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

  2. Change of eating attitudes and behaviors

    Time frame: 16 days

    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.

Secondary outcomes

  1. Change of self-esteem

    Time frame: 16 days

    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

  2. Change in social anxiety symptoms

    Time frame: 16 days

    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

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
Sep 25, 2019
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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