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

NCT06551974 | Recruiting

• 1 other identifier: Prot. P202237PFB
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eating Disorder Symptom; Eating Disorders; Eating Behavior

Keywords

eating disorders; guided self-help; online intervention; peer mentoring; tailored interventions; interpersonal group; therapeutic alliance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change from baseline in the Eating Disorder Examination Questionnaire

  Baseline, 8 weeks, and 3-month follow-up.

• Change from baseline in the Inventory of Interpersonal Problems

  Baseline, 8 weeks, and 3-month follow-up.

• Change from baseline in the Autonomous and Controlled Motivation for Treatment Questionnaire

  Baseline, 8 weeks, and 3-month follow-up.

• Change from baseline in the Difficulties in Emotion Regulation Scale

  Baseline, 8 weeks, and 3-month follow-up.

• Change from baseline in the Client Satisfaction Questionnaire

  Baseline, 8 weeks, and 3-month follow-up.

Other Outcomes (3)

• Change from baseline in the EQ-5D-5L

  Baseline, 8 weeks, and 3-month follow-up.

• Change from baseline in Body Mass Index

  Baseline, weekly, 8 weeks, and 3-month follow-up.

• Change from baseline in use of care services

  Baseline, 8 weeks, and 3-month follow-up.

Study Arms (4)

Guided self-help plus IPT

EXPERIMENTAL

The participants will have access to self-help materials (workbook and videoclips), forum groups (interactional materials), online interpersonal group sessions for 8 weeks. Participants will use self-help materials through a mobile app and online platform. Regarding anorexic symptoms and behaviours, the self-help material will focus on the topics of the New Maudsley model. Further modules will cover the ED overeating problems and the interpersonal difficulties related to EDs. The weekly online forum group is focused on interactional material that will be delivered weekly through a synchronous 1-hour mobile chat with a peer mentor (a recovered influencer). Each session lasts 60 minutes and is themed following the structure of the video-clips materials. Finally, 90-minute interpersonal group sessions will be led online by clinicians with an expertise in the treatment of eating disorders.

Behavioral: Guided self-help plus IPT

Treatment-as-usual

ACTIVE COMPARATOR

Treatment as usual will vary between centres and this will impact the effect size of the intervention (Ayling et al., 2015). We will therefore conduct structured interviews with clinicians at each study site to clarify the nature of treatment as usual at each centre. We will also use an adapted form of the Client Service Receipt Inventory (a well-established tool used in health economics) to track the amount of treatment received over the year (Beecham \& Knapp, 1992). The inventory will be administered at 8-week and 3-month, to measure patients' service usage.

Behavioral: TAU

Guided self-help

EXPERIMENTAL

The participants will have access to self-help materials (workbook and videoclips), and forum groups (interactional materials). Participants will use self-help materials through a mobile app and online platform. Regarding anorexic symptoms and behaviours, the self-help material will focus on the topics of the New Maudsley model. Further modules will cover the ED overeating problems and the interpersonal difficulties related to EDs. The weekly online forum group is focused on interactional material that will be delivered weekly through a synchronous 1-hour mobile chat with a peer mentor (a recovered influencer). Each session lasts 60 minutes and is themed following the structure of the video-clips materials.

Behavioral: Guided self-help

No treatment

NO INTERVENTION

The no-treatment control condition includes participants with sub-threshold eating symptoms who attend regular visits with their own primary care physician. In this context, it is important that participants, interested to take part to the study, offered number or contact of the own primary care physician in case of an illness worsening.

Interventions

Guided self-help plus IPT BEHAVIORAL

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 plus IPT

Guided self-help BEHAVIORAL

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.

Guided self-help

TAU BEHAVIORAL

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

Treatment-as-usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• For both study 1and 2: acute psychosis, clinical depression or suicidal ideation, pregnancy, use of medication that might influence eating behavior, neurological and visual impairment and Intellectual disability.

Sponsors & Collaborators

• University of Palermo: lead
• University of Catanzaro: collaborator
• University of Padova: collaborator

Study Sites (1)

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

Catanzaro, 88100, Italy

RECRUITING

Related Publications (1)

• Lo Coco G, Albano G, Gullo S, Cardi V, Segura-Garcia C. 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. J Eat Disord. 2025 Jun 23;13(1):119. doi: 10.1186/s40337-025-01320-z.

  PMID: 40551261 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders; Feeding Behavior

Interventions

adenylate isopentenyltransferase

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior, Animal; Behavior

Study Officials

• Gianluca Lo Coco

  University of Palermo

  PRINCIPAL INVESTIGATOR

• Cristina Segura-Garcia

  University of Catanzaro

  STUDY DIRECTOR

Central Study Contacts

Gianluca Lo Coco

CONTACT

+39 09123897725; gianluca.lococo@unipa.it

Cristina Segura Garcia

CONTACT

+39 0961712408; segura@unicz.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: November 15, 2024
• Primary Completion: July 31, 2025
• Study Completion: October 31, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

IT (1)