Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06551974

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

Led by University of Palermo · Updated on 2024-12-13

242

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

Sponsors

U

University of Palermo

Lead Sponsor

U

University of Catanzaro

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • For outpatient study: diagnosis of an eating disorder based on DSM-5-TR criteria
  • Started treatment as usual within the past 12 months (outpatient study)
  • For community study: score above 2.77 on the Eating Disorders Examination Questionnaire
  • Not currently receiving treatment for eating disorder symptoms (community study)
  • Regular monitoring by a primary care physician (community study)
  • Access to internet via a mobile device
  • Italian speaking
Not Eligible

You will not qualify if you...

  • Acute psychosis
  • Clinical depression or suicidal thoughts
  • Pregnancy
  • Use of medication that might affect eating behavior
  • Neurological or visual impairments
  • Intellectual disability

AI-Screening

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Trial Site Locations

Total: 1 location

1

Outpatient Unit for Clinical research and Treatment of Eating Disorders. University Hospital Mater Domini

Catanzaro, Italy, 88100

Actively Recruiting

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Research Team

G

Gianluca Lo Coco

CONTACT

C

Cristina Segura Garcia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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