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

Condition(s) studied

Investigational drug(s) / intervention(s)

Metacognitive Training for Eating Disorders: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Recruitment rate — Through study completion, an average of 1 year
  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
• Retention/Completion rate — Through study completion, an average of 1 year
  Proportion of participants who completed the full intervention and all planned outcome assessments Minimum Progression Criterion: ≥ 70% of participants complete the intervention and assessments
• Intervention engagement / adherence — Through study completion, an average of 1 year
  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.
• Safety and adverse events — Through study completion, an average of 1 year
  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.
• Participant evaluation — During week 7 following intervention initiation
  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.
• Semi-structured interviews — During week 8 following intervention initiation
  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.

Trial sites (1)

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