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

NCT04103606 | Completed

• 1 other identifier: 2936
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Body Image Disorder; Body Dysmorphic Disorders; Eating Disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change of self-esteem

  16 days

• Change in social anxiety symptoms

  16 days

Study Arms (2)

immediate-use App group (iApp group)

EXPERIMENTAL

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)

delayed-use App group (dApp)

ACTIVE COMPARATOR

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)

Interventions

GGBI: Positive Body Image (Mobile App) DEVICE

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

delayed-use App group (dApp); immediate-use App group (iApp group)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of Body Image Disorder symptoms

You may not qualify if:

• Presence of a full-blown Body Image Disorder
• Presence of a psychotic/schizophrenic disorder
• Current treatment for a Body Image Disorder

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University of Padua

Padua, PD, 35131, Italy

Location

MeSH Terms

Conditions

Body Dysmorphic Disorders; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 25, 2019
• Study Start: January 30, 2019
• Primary Completion: July 31, 2019
• Study Completion: December 31, 2021
• Last Updated: November 19, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)