Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04103606
Other study ID # 2936
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05656859 - Prevalence of Eating Disorders Among Patients in the Department of Health Promotion
Completed NCT04085861 - Mental Health in Dancers; an Intervention Study N/A
Recruiting NCT05651295 - A Precision Medicine Approach to Target Engagement for Emotion Regulation N/A
Enrolling by invitation NCT04174703 - Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing N/A
Terminated NCT04278755 - Binge Eating & Birth Control Phase 2
Withdrawn NCT03050632 - Effects of Cognitive and Emotional Functioning on Treatment Outcomes N/A
Completed NCT02484794 - Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application N/A
Completed NCT02567890 - Swedish Body Project for Prevention of Eating Disorders N/A
Completed NCT02252822 - Improving Treatment Engagement for Adolescents With Bulimia Nervosa N/A
Completed NCT02021344 - Mental Health First Aid for College Students N/A
Completed NCT00601354 - Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder N/A
Completed NCT00418977 - Comparing the Effectiveness of Two Therapies to Treat Signs of Anorexia Nervosa in Adolescents N/A
Completed NCT00304187 - Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa Phase 2
Completed NCT00733525 - Effectiveness of Stepped Care Versus Best Available Care for Bulimia Nervosa N/A
Active, not recruiting NCT04779216 - Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa Phase 3
Completed NCT04433663 - Eating Disorders, Self Regulation and Mentalization N/A
Recruiting NCT05509257 - Naltrexone Neuroimaging in Teens With Eating Disorders Early Phase 1
Completed NCT04509531 - Building Resilience in Cyberbullying Victims N/A
Recruiting NCT05730348 - Mealtime Anxiety in Eating Disorders
Enrolling by invitation NCT05814653 - A Study to Evaluate Primary Care Treatment for Adolescent Eating Disorders N/A