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Anorexia NervosaMCT-EDNCT07435818

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

A study testing Metacognitive Training for Eating Disorders in people with Anorexia Nervosa and Atypical Anorexia Nervosa, run by University of Évora at 1 site in Portugal.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 19 years
Conditions the study is for
Anorexia Nervosa, Atypical Anorexia Nervosa
What is being tested?
Metacognitive Training for Eating Disorders
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 sitePortugal
Study dates
2 Mar 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andreia Espírito Santo, PhD Student contact

00351219 847 200

acj.santo@ensp.unl.pt

Lara Pinho, PhD contact

l.pinho@ess.ipvc.pt

Portugal1 site, 1 recruiting
  • Hospital Beatriz Ângelo - Unidade Local de Saúde Loures-Odivelas, Child and Adolescent Psychiatry Service, Department of Psychiatry and Mental Health, Loures, Portugal

    Loures

    Andreia Espírito Santo, PhD Student, 00351 21 984 7200, acj.santo@ensp.unl.pt

    Lara Pinho, PhD, l.pinho@ess.ipvc.pt

    Recruiting

Other trials in Portugal

About this study

Official title: Feasibility and Acceptability of Metacognitive Training for Eating Disorders (MCT-ED) in Adolescents With Anorexia Nervosa

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.

Read the detailed description

Anorexia nervosa is the eating disorder associated with the highest mortality rate, with peak incidence occurring during adolescence. Recent studies indicate that, globally, the incidence of adolescent anorexia nervosa has increased by approximately 17% over the past 30 years, with a further rise observed during and following the COVID-19 pandemic. The consequences of untreated anorexia nervosa extend into adulthood, significantly affecting both physical and mental health, resulting in long-term morbidity and a substantial burden on society. Elevated levels of perfectionism and cognitive inflexibility are commonly observed in this population and are thought to contribute to the maintenance of eating disorder symptoms as well as resistance to treatment. Accordingly, the MCT-ED aims to reduce rigid and inflexible thinking styles, decrease perfectionism, and address cognitive biases that perpetuate the symptoms of the disorder.

The primary aim of this feasibility study is to assess key process indicators, including recruitment, retention, adherence to the intervention, and safety. To ensure reproducibility, a session checklist will be used to document both intervention delivery and participant engagement for each session. A minimum fidelity plan will include routine supervision of intervention delivery by a senior team researcher with expertise in metacognitive training, optionally supported by an additional research team member with experience in eating disorders and adolescent populations.

Potential participants are referred to the study by the treatment clinical team (child and adolescent psychiatrist/psychiatrist) during eating disorder consultations, only after the adolescent and/or their parent/guardian have provided explicit consent for their contact details to be shared with the research team. For recruitment purposes, a member of the research team contacts potential participants by telephone to schedule an initial videoconference meeting with the adolescent and their legal guardians.

All participants will be invited to take part in an optional brief interview at the end of the intervention and completion of all study assessments. Interviews are conducted via videoconference by a member of the research team who is independent from the therapist who delivered the intervention. The semi-structured interview explores participants' perceptions of the intervention, including overall evaluation, perceived benefits, most and least useful components, age-appropriateness, comprehension, session format and structure, exercises and workbooks, study questionnaires, potential involvement of caregivers, and suggestions for improvement. This approach allows systematic collection of feedback on acceptability, practicality, and potential areas for refinement. Participants who choose not to participate will still have their study participation preserved, including attendance at intervention sessions and completion of study questionnaires.

For CONSORT reporting purposes, the number of participants allocated to the intervention, those who received the intervention, and those who did not receive the intervention, together with reasons, will be documented. In addition, losses to follow-up and discontinuation of the intervention, including reasons where possible, will be recorded. Finally, the number of participants invited to take part in the qualitative interview and the number who completed the interview will be documented.

Progression decisions in this feasibility and acceptability study are guided by predefined criteria using a three-tiered traffic-light system to support interpretation and decision-making.

Being tested
Metacognitive Training for Eating Disorders
Keywords
Feasibility Studies, adolescent, anorexia nervosa, metacognitive training, feeding and eating disorders
Medical subject headings
Anorexia Nervosa, Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metacognitive Training for Eating DisordersBehavioural

    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 groups in NCT07435818
Study groupRoleWhat they receive
Metacognitive Training for Eating Disorders + Treatment as usual (TAU)ExperimentalAdolescents with Anorexia Nervosa ou Atypical Anorexia Nervosa. The adolescent continues to receive any ongoing standard care (treatment as usual, TAU)
Receives: Behavioral: Metacognitive Training for Eating Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Through study completion, an average of 1 year

  2. 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

    Measured: Through study completion, an average of 1 year

  3. 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.

    Measured: Through study completion, an average of 1 year

  4. 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.

    Measured: Through study completion, an average of 1 year

  5. 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.

    Measured: During week 7 following intervention initiation

  6. 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.

    Measured: During week 8 following intervention initiation

Secondary outcomes (3)
  1. ED behaviours and attitudes: Eating Disorder Examination Questionnaire -(EDE-Q) (Fairburn & Beglin, 1994); Portuguese validated version EDE-Q 5.2. (Machado et al., 2014)

    The EDE-Q is a self-report instrument consisting of 28 items across four subscales: Restraint, Eating Concern, Shape Concern, and Weight Concern. Items are rated on a 7-point Likert scale (0-6), with higher scores indicating greater concern with eating, weight, and body shape and/or more maladaptive eating-related behaviours. The questionnaire assesses both cognitive-attitudinal features and the frequency of key disordered eating behaviours over a 28-day reference period. A higher global score reflects greater overall severity of eating disorder symptoms. To obtain a subscale score, the ratings for the relevant items are added together and the sum divided by the total number of items forming the subscale. To obtain an overall or 'global' score, the four subscales' scores are summed and the resulting total divided by the number of subscales (i.e. four).

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

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

    The Organization subscale consists of six items. Each item is rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). The total FMPS score was calculated by summing five subscales (Personal Standards, Concern over Mistakes, Doubts about Actions, Parental Expectations, and Parental Criticism), excluding the Organization subscale due to its weaker correlations with the other dimensions. The Organization subscale is reported separately. All items are scored in the same direction, with higher scores indicating greater levels of perfectionism in each domain. Elevated scores reflect stronger perfectionistic tendencies, including heightened concern about mistakes, higher personal standards, perceived parental pressure, doubts about performance, and preference for organization.

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

  3. 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)

    The BI-AAQ is a self-report instrument consisting of 12 items that measure body image-related psychological flexibility, including body image acceptance and experiential avoidance. Each item is rated on a 7-point Likert scale (1 = never true, 7 = always true). All items are reverse-scored so that higher scores reflect greater body image-related psychological flexibility and acceptance, whereas lower scores indicate higher inflexibility and experiential avoidance. The total score is calculated as the sum of all 12 items, resulting in a possible range of 12 to 84.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start2 Mar 2026
  3. Primary completionMar 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Metacognitive Training for Eating Disorders
Masking
None (open label)
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07435818
Sponsor's protocol ID
2024.15211.DAP
Acronym
MCT-ED
Status last verified
Mar 2026
First submitted
15 Feb 2026
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Metacognitive Training for Eating Disorders in people with Anorexia Nervosa and Atypical Anorexia Nervosa, run by University of Évora at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andreia Espírito Santo, PhD Student (00351219 847 200, acj.santo@ensp.unl.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: Through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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