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

Condition(s) studied

Investigational drug(s) / intervention(s)

Guided self-help plus IPT: The participants allocated in the intervention GSH arm will have access to self-help materials (workbook and videoclips), forum groups (interactional materials), online interpersonal group sessions for 8 weeks. The proposed online GSH will be adapted from two online interventions developed and tested with people with eating disorders by the Eating Disorders Research Unit team at King's College London, with a cooperation of the University of Palermo research team (Cardi et al., 2020). The GSH will include self-help materials, i.e. a written workbook and a library of 74 brief video-clips with the goal of providing psychoeducation about eating disorders and interpersonal difficulties and describing and modelling the use of helpful strategies to reverse abnormal eating behaviours. Participants will also attend a weekly online forum with interactional materials, and an online interpersonal group session.

Guided self-help: The participants allocated in the intervention GSH arm will have access to self-help materials (workbook and videoclips), forum groups (interactional materials), online interpersonal group sessions for 8 weeks. The proposed online GSH will be adapted from two online interventions developed and tested with people with eating disorders by the Eating Disorders Research Unit team at King's College London, with a cooperation of the University of Palermo research team (Cardi et al., 2020). The GSH will include self-help materials, i.e. a written workbook and a library of 74 brief video-clips with the goal of providing psychoeducation about eating disorders and interpersonal difficulties and describing and modelling the use of helpful strategies to reverse abnormal eating behaviours.

TAU: The Treatment as Usual is the usual or routine care provided to participants in the outpatient setting.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change from baseline in Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM): — Baseline, end-of-treatment (8 weeks), and 3-month follow-up.
  The CORE-OM is a 34-item validate, self-report scale (of which 25% are reverse items) assessing global distress of the subject across 4 domains: \[Well-being (4 items); Functioning (12 items); Problems/symptoms (12 items); Risk (to self and to others) (6 items)\] over the last week. Items are answered on the same five-point scale (0-4) ranging from 'not at all' to 'most or all the time'. Overall, the measure is problem scored (i.e. higher scores indicate more problems). Scores are reported as means across items that give a 'pro-rated' score if there are incomplete responses.

Trial sites (1)

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