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

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated December 13, 2024 (before its estimated July 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 1, 2024 to Nov 15, 2024
    • Eligibility criteria revised
    • Study description expanded, about 21 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06551974
Lead Sponsor University of Palermo
Collaborators: University of Catanzaro, University of Padova
Conditions
(from sponsor)
Eating Disorder Symptom, Eating Disorders, Eating Behavior
Related terms Feeding and Eating Disorders, Feeding Behavior
Enrollment 242 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov