NCT06551974

INTERconNEcT-Eds: a Guided Self-help Mobile App to Improve Outcome in Eating Disorders

Recruiting now NA Last updated 13 December 2024

What this trial tests

NA trial testing Guided self-help plus IPT in Eating Disorder Symptom in 242 participants. Currently enrolling.

Timeline

15 November 2024

Primary endpoint
31 July 2025

31 October 2025

Quick facts

Lead sponsor	University of Palermo
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	242
Start date	15 November 2024
Primary completion	31 July 2025
Estimated completion	31 October 2025
Sites	1 location across Italy

Drugs / interventions tested

• Guided self-help plus IPT
• Guided self-help
• TAU — full drug profile →

Conditions studied

• Eating Disorder Symptom — all drugs for Eating Disorder Symptom →
• Eating Disorders — all drugs for Eating Disorders →
• Eating Behavior — all drugs for Eating Behavior →

Sponsor

University of Palermo

Who can join

18 and older, any sex, with Eating Disorder Symptom or Eating Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Eating disorders (EDs) are psychiatric illnesses characterised by pathological eating behaviours, ranging from protracted undereating to recurrent loss of control over eating. Based on the transdiagnostic approach, EDs are triggered and maintained by interpersonal distress and difficulties to manage negative emotions. Thus, interpersonal skills have been implicated as important targets for change in the treatment. In this project, we will adopt digital technologies to improve treatment adherence and outcome of individuals with EDs, by testing the effectiveness of an online self-help program delivered through a mobile app. Specifically, this project aims to establish if an online personalized self-help approach is feasible and effective in ameliorating eating disorder symptoms and distress. We planned to conduct two randomised controlled trials to test the effectiveness of online guided self-help (GSH) in two different settings: (1) the community, and (2) the outpatient setting. This is to establish at which stage of treatment this approach is most helpful. Across studies, we will recruit 242 individuals aged ≥18 years with ED symptoms and/or a proper diagnosis of EDs (DSM-5). During eight weeks period, GSH will be available to participants both on a website and a new-developed smartphone app and consists of written materials and brief video-clips, a weekly chat based forum group and an online interpersonal group session. Guidance in forum groups will be facilitated by non-specialist help-care providers (i.e., peer mentors); whereas experienced mental health providers will lead the online group sessions. Participant's interpersonal distress will be assessed at intake to personalize guidance in the group, by addressing dysfunctional interpersonal characteristics which can be associated with ED symptoms. Participants will also complete a weekly working alliance measure to examine whether the quality of relationship with mentor predicts clients' level of clinical change.

Regarding the outpatient setting, the first aim is to assess if GSH intervention is effective to improve the following primary outcome for patients with ED diagnosis: 1) overall psychological distress. In the community setting, the study aims to examine if GSH is effective to improve the following primary outcomes for individuals with self-reported ED symptoms: 1) overall psychological distress; 2) first contact with clinical services to manage their dysfunctional eating behaviors.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The feasibility, acceptability and clinical impact of a guided self-help mobile intervention (INTERconNEcT-EDs) for individuals with eating disorders: protocol for two multicenter randomized controlled trials.
   Lo Coco G, Albano G, Gullo S, Cardi V, et al · · 2025 · cited 2× · PMID 40551261 · DOI 10.1186/s40337-025-01320-z
2. The INTERconNEcT-EDs app-based self-help program for people with eating disorders: a usability and qualitative study.
   Albano G, Semola M, Tosi C, Quirino D, et al · · 2025 · PMID 41281295 · DOI 10.3389/fdgth.2025.1629203