INTERconNEcT-Eds: a Guided Self-help Mobile App to Improve Outcome in Eating Disorders
NCT Number: NCT06551974
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Eating Disorder Symptom|Eating Disorders|Eating Behavior
Interventions: BEHAVIORAL: Guided self-help plus IPT|BEHAVIORAL: Guided self-help|BEHAVIORAL: TAU
Sponsor: University of Palermo
Collaborators: University of Catanzaro|University of Padova
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 242
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-10-31

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 sub-threshold EDs: 1) overall psychological distress; 2) first contact with clinical services to manage their dysfunctional eating behaviors.

Primary Outcome Measures: Change from baseline in Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM):, 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., Baseline, end-of-treatment (8 weeks), and 3-month follow-up.
Secondary Outcome Measures: Change from baseline in the Eating Disorder Examination Questionnaire, Questionnaire (EDE-Q 6.0): it is a self-report scale assessing eating disorder psychopathology and behaviors. The questionnaire is made up of 22 items, rated on a 7-point from 0 to 6. Higher scores reflecting greater severity or frequency. It also provides frequency data on key behavioral features of eating disorders, in terms of the number of episodes of the behavior over the preceding 28 days, and the number of days on which the behavior has occurred. Items are grouped into 4 subscales: restraint, weight concern, shape concern and eating concern., Baseline, 8 weeks, and 3-month follow-up.|Change from baseline in the Inventory of Interpersonal Problems, The IIP-32 is a self-report scale 32-item inventory of distressing interpersonal behaviours the respondent identifies as "hard to do" (i.e., behavioural inhibitions) or "does too much" (i.e., behavioural excesses) on a 0 (not at all) to 4 (extremely) Likert scale. It provides an overall score and 8 subscale scores: (Domineering/Controlling, Vindictive/Self-centered, Cold/distant, Socially inhibited, Nonassertive, Overly accommodating, Self-sacrificing, Intrusive needy).

Higher scores in each scale indicate the presence of interpersonal difficulties., Baseline, 8 weeks, and 3-month follow-up.|Change from baseline in the Autonomous and Controlled Motivation for Treatment Questionnaire, The ACMTQ consists of two subscales assessing autonomous and controlled motivation for treatment through 12-items on a seven-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate a stronger endorsement of the motivation type., Baseline, 8 weeks, and 3-month follow-up.|Change from baseline in the Difficulties in Emotion Regulation Scale, The Difficulties in Emotion Regulation Scale (DERS) is a 5-point self-report instrument measuring emotion regulation problems. The 36 items (of which 11 are reverse items) asks respondents how they relate to their emotions in order to produce scores on the following subscales: non acceptance of emotional responses, difficulty engaging in goal-directed behaviour, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, lack of emotional clarity. Higher scores suggest greater problems with emotion regulation., Baseline, 8 weeks, and 3-month follow-up.|Change from baseline in the Client Satisfaction Questionnaire, The Client Satisfaction Questionnaire is an eight-item self-report measure aimed at measuring participant satisfaction with treatment, with a Likert scale ranging from 0 to 6. Higher scores indicate better outcome. In the present study, the researchers adapted the CSQ to include one additional question to measure satisfaction with online-based treatment., Baseline, 8 weeks, and 3-month follow-up.
Other Outcome Measures: Change from baseline in the EQ-5D-5L, The EQ-5D-5L descriptive system includes ﬁve dimensions: mobility (MO), self-care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD). Each dimension is articulated into ﬁve severity levels: no problems, slight problems, moderate problems, severe problems, extreme problems. The EQ-5D questionnaire also includes a visual analogue scale (EQ VAS) on which participants indicated their self-rated health at the time between 0 (worst imaginable health) and 100 (best imaginable health)., Baseline, 8 weeks, and 3-month follow-up.|Change from baseline in Body Mass Index, Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.

BMI categories:

Underweight = \<18.5 Normal weight = 18.5-24.9 Overweight = 25-29.9 Obesity = BMI of 30 or greater, Baseline, weekly, 8 weeks, and 3-month follow-up.|Change from baseline in use of care services, Participant's Service Use (PSU). Participants in study 2 will indicate the type of care service used in the last 6 weeks and the number of days they have used a service in the last 6 weeks., Baseline, 8 weeks, and 3-month follow-up.