Feasibility and Acceptability of Metacognitive Training for Eating Disorders in Adolescents With Anorexia Nervosa

NCT07435818 | Recruiting

• 1 other identifier: 2024.15211.DAP
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the feasibility and acceptability of Metacognitive Training for Eating Disorders (MCT-ED) in adolescents with anorexia nervosa and atypical anorexia nervosa.

Conditions

Anorexia Nervosa; Atypical Anorexia Nervosa

Keywords

Feasibility Studies; adolescent; anorexia nervosa; metacognitive training; feeding and eating disorders

Outcome Measures

Primary Outcomes (6)

• Recruitment rate

  Proportion of eligible participants who consent to participate in the study, calculated as the number recruited divided by the number eligible and approached Minimum Progression Criterion: ≥ 50% of eligible participants consent to participate

  Through study completion, an average of 1 year

• Retention/Completion rate

  Proportion of participants who completed the full intervention and all planned outcome assessments Minimum Progression Criterion: ≥ 70% of participants complete the intervention and assessments

  Through study completion, an average of 1 year

• Intervention engagement / adherence

  Number of synchronous sessions attended (out of six), which determines exposure to the six intervention modules, and level of engagement during sessions. Engagement with recommended between-session exercises, which are not mandatory, will also be recorded as an indicator of optional participation rather than required adherence Minimum Progression Criterion: ≥83% of participants attend at least 5 of the 6 synchronous sessions and demonstrate adequate in-session engagement, defined as participation in at least one core exercise per attended session. Engagement with recommended workbook exercises related to the core modules (cognitive flexibility and perfectionism) will be recorded descriptively through therapist review of the workbook and will not constitute a mandatory criterion for progression.

  Through study completion, an average of 1 year

• Safety and adverse events

  Adverse events are defined as any unexpected or clinically significant occurrences potentially related to the intervention, including: * Clinical deterioration: marked increase in core AN symptoms (e.g., restrictive eating, purging, excessive exercise) compared to baseline; * Suicidal ideation or self-harm: thoughts, plans, or behaviours indicating risk of self-injury; * Need for urgent medical intervention: emergency visits, hospitalization, or other urgent care; * Other unexpected adverse events potentially linked to the study participation. Intervention suspension criteria: * Severe clinical deterioration in AN symptoms * Emergence of suicidal ideation or self-harm behaviours Mild or moderate adverse events do not automatically lead to suspension but are monitored and managed in coordination with the treating clinician. Minimum Progression Criterion: No severe adverse events attributable to the intervention.

  Through study completion, an average of 1 year

• Participant evaluation

  A 16-item questionnaire is administered to participants upon completion of the intervention and all post-intervention assessments. The questionnaire is designed to assess participant satisfaction and the acceptability of the Metacognitive Training for Eating Disorders (MCT-ED). Items 1-14: Rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). These items assess key aspects of participants' experience, including: Usefulness and applicability of the content in daily life; Motivation and engagement with the sessions; Understanding of objectives and content; Satisfaction with session format and accessibility (online, individual, and appropriate sessions and intervention duration); Overall satisfaction and intention to recommend the intervention. Items 15-16: Open-ended questions collecting qualitative feedback.

  During week 7 following intervention initiation

• Semi-structured interviews

  All participants who have completed the intervention and the study assessments are offered the opportunity to take part in an optional interview at the end of the study. All participants who agree to take part are interviewed. Interviews are conducted via videoconference by a member of the research team who is independent from the therapist delivering the intervention. The interview explores participants' perceptions of the intervention, including their overall evaluation, the components they found most and least useful, age-appropriateness and comprehension, suggestions for improvement, the structure and dose of sessions, the format (individual, online, videoconference), the workbooks and exercises, the study questionnaires, the potential involvement of caregivers, and any final reflections or additional comments. This approach ensures systematic collection of feedback on acceptability, perceived benefits, practicality, and potential improvements.

  During week 8 following intervention initiation

Secondary Outcomes (3)

• ED behaviours and attitudes: Eating Disorder Examination Questionnaire -(EDE-Q) (Fairburn & Beglin, 1994); Portuguese validated version EDE-Q 5.2. (Machado et al., 2014)

  Baseline (up to one week before the intervention) and Immediately after the intervention (up to one week after the end of the intervention)

• Perfectionism: Frost Multidimensional Perfectionism Scale (FMPS) (Frost et al., 1990). The Portuguese version of the FMPS validated by Carmo et al. (2017)

  Baseline (up to one week before the intervention) and Immediately after the intervention (up to one week after the end of the intervention)

• Cognitive Flexibility/Body Image Flexibility: Body Image Acceptance and Action Questionnaire (BI-AAQ) (Sandoz et al., 2013); Portuguese validated version: Ferreira, C., Pinto-Gouveia, J., & Duarte, C. (2011)

  Baseline (up to one week before the intervention) and Immediately after the intervention (up to one week after the end of the intervention)

Study Arms (1)

Metacognitive Training for Eating Disorders + Treatment as usual (TAU)

EXPERIMENTAL

Adolescents with Anorexia Nervosa ou Atypical Anorexia Nervosa. The adolescent continues to receive any ongoing standard care (treatment as usual, TAU)

Behavioral: Metacognitive Training for Eating Disorders

Interventions

Metacognitive Training for Eating Disorders BEHAVIORAL

The intervention consists of six modules delivered across six synchronous sessions, each lasting up to 50 minutes, over a six-week period, and conducted by a mental health specialist nurse. The intervention includes one thinking styles module, two cognitive flexibility modules, two perfectionism modules, and one concluding summary module. At the beginning of each session, exercises completed at home between sessions are reviewed. All sessions are conducted individually via a video-conferencing platform, with materials presented using Microsoft PowerPoint®. Each module incorporates psychoeducational content, interactive exercises, videos, and guided reflection activities.

Metacognitive Training for Eating Disorders + Treatment as usual (TAU)

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents aged 13 to 19 years;
• Diagnosis of Anorexia Nervosa or Atypical Anorexia Nervosa; confirmed by the treating child and adolescent psychiatrist according to DSM-5-TR or ICD-11 criteria;
• Currently followed in an Eating Disorder Outpatient Consultation;
• Fluent in Portuguese.

You may not qualify if:

• Acute suicidal ideation or behaviour requiring immediate clinical intervention;
• Imminent risk of hospitalization due to clinical deterioration;
• Current diagnosis of psychotic disorder, bipolar disorder, or substance dependence;
• Any clinical condition that, in the judgment of the treating clinician, would make participation in a videoconference-based intervention inappropriate.

Sponsors & Collaborators

• University of Évora: lead
• Fundação para a Ciência e a Tecnologia: collaborator
• Universidade Nova de Lisboa: collaborator
• Comprehensive Health Research Center: collaborator

Study Sites (1)

Hospital Beatriz Ângelo - Unidade Local de Saúde Loures-Odivelas, Child and Adolescent Psychiatry Service, Department of Psychiatry and Mental Health, Loures, Portugal

Loures, Portugal

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Lara Pinho, PhD

  Universidade de Évora, Comprehensive Health Research Centre (CHRC) LA-REAL, Évora, Portugal

  STUDY CHAIR

• Francisco Sampaio

  Nursing School of the University of Porto, Porto, Portugal

  STUDY CHAIR

• Andreia Espírito Santo, PhD Student

  NOVA National School of Public Health, Comprehensive Health Research Centre, REAL, CCAL, Portugal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreia Espírito Santo, PhD Student

CONTACT

00351219 847 200; acj.santo@ensp.unl.pt

Lara Pinho, PhD

CONTACT

l.pinho@ess.ipvc.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student, Principal Investigator

Model Details: Metacognitive Training for Eating Disorders

Study Record Dates

• First Submitted: February 15, 2026
• First Posted: February 27, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

PT (1)