Actively Recruiting
Led by University of Palermo · Updated on 2024-12-13
242
Participants Needed
1
Research Sites
13 weeks
Total Duration
U
University of Palermo
Lead Sponsor
U
University of Catanzaro
Collaborating Sponsor
Eating disorders are psychiatric illnesses involving harmful eating behaviors, from prolonged undereating to repeated loss of control over eating. These disorders are often triggered and maintained by interpersonal distress and difficulties managing negative emotions. This research aims to evaluate an online personalized guided self-help program delivered via a mobile app to improve treatment adherence and outcomes for individuals with eating disorders, by testing its effectiveness in both community and outpatient settings. The study includes two randomized controlled trials with 242 participants aged 18 and older who have eating disorder symptoms or diagnoses. The intervention lasts eight weeks and features self-help materials, including written workbooks and video clips, weekly online forum chats with peer mentors, and online interpersonal group sessions led by experienced clinicians. Participants in the outpatient setting receive guided self-help plus interpersonal therapy in addition to their usual treatment, while those in the community setting receive guided self-help without group sessions or treatment as usual. Participants will complete assessments at the start, end of treatment (8 weeks), and three-month follow-up. These include measures of psychological distress, eating disorder symptoms, interpersonal problems, motivation for treatment, emotion regulation, and satisfaction with treatment. The study also tracks if community participants begin clinical treatment during or after the trial. Researchers will analyze how the quality of the relationship with mentors relates to clinical changes during the intervention.
CONDITIONS
INTERconNEcT-Eds: a Guided Self-help Mobile App to Improve Outcome in Eating Disorders
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment and baseline questionnaires
Duration - 8 weeks
Participants with a diagnosed eating disorder receive access to self-help materials via a mobile app, including workbooks and video clips, weekly online forum groups with peer mentors, and weekly 90-minute online interpersonal group sessions led by clinicians for 8 weeks.
Weekly online group sessions and forum participation
Duration - 8 weeks
Participants have access to self-help materials through a mobile app, including workbooks and video clips, and participate in weekly online forum groups with peer mentors for 8 weeks, without interpersonal group sessions.
Weekly online forum sessions
Duration - 8 weeks
Participants receive routine care for eating disorders as provided by their treatment center, which may vary between centers.
Visits as per routine care at treatment centers
Duration - 8 weeks
Participants with symptoms of eating disorders not currently receiving treatment access self-help materials via a mobile app, including workbooks and video clips, and participate in weekly online forum groups with peer mentors for 8 weeks.
Weekly online forum sessions
Duration - 8 weeks
Participants with sub-threshold eating disorder symptoms attend regular visits with their primary care physician without receiving additional treatment through the study.
Regular visits with primary care physician as usual
Duration - 3 months
Participants are followed up to assess outcomes including psychological distress, eating disorder symptoms, and quality of life after the 8-week intervention period.
1 follow-up visit or remote assessment
Total: 1 location
1
Outpatient Unit for Clinical research and Treatment of Eating Disorders. University Hospital Mater Domini
Catanzaro, Italy, 88100
Actively Recruiting
G
Gianluca Lo Coco
C
Cristina Segura Garcia
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Gianluca Lo Coco, Gaia Albano, Salvatore Gullo...
https://pubmed.ncbi.nlm.nih.gov/40551261