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

Sponsor
University of Padova (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04103606
Collaborator
(none)
100
1
2
31
3.2

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Device: GGBI: Positive Body Image (Mobile App)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jan 30, 2019
Actual Primary Completion Date :
Jul 31, 2019
Anticipated Study Completion Date :
Aug 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change of body dissatisfaction and body dysmorphic disorder symptoms [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 [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 Outcome Measures

  1. Change of self-esteem [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Padua Padua PD Italy 35131

Sponsors and Collaborators

  • University of Padova

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Silvia Cerea, Postdoctoral Research Fellow, University of Padova
ClinicalTrials.gov Identifier:
NCT04103606
Other Study ID Numbers:
  • 2936
First Posted:
Sep 25, 2019
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2021