Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:41 AM
Study NCT ID:
NCT07435818
Status:
RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Acceptability of Metacognitive Training for Eating Disorders in Adolescents With Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Metacognitive Training for Eating Disorders'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-02-15', 'studyFirstSubmitQcDate': '2026-02-21', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': 'Through study completion, an average of 1 year', 'description': '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'}, {'measure': 'Retention/Completion rate', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Proportion of participants who completed the full intervention and all planned outcome assessments Minimum Progression Criterion: ≥ 70% of participants complete the intervention and assessments'}, {'measure': 'Intervention engagement / adherence', 'timeFrame': 'Through study completion, an average of 1 year', 'description': '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.'}, {'measure': 'Safety and adverse events', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Adverse events are defined as any unexpected or clinically significant occurrences potentially related to the intervention, including:\n\n* Clinical deterioration: marked increase in core AN symptoms (e.g., restrictive eating, purging, excessive exercise) compared to baseline;\n* Suicidal ideation or self-harm: thoughts, plans, or behaviours indicating risk of self-injury;\n* Need for urgent medical intervention: emergency visits, hospitalization, or other urgent care;\n* Other unexpected adverse events potentially linked to the study participation.\n\nIntervention suspension criteria:\n\n* Severe clinical deterioration in AN symptoms\n* Emergence of suicidal ideation or self-harm behaviours\n\nMild or moderate adverse events do not automatically lead to suspension but are monitored and managed in coordination with the treating clinician.\n\nMinimum Progression Criterion: No severe adverse events attributable to the intervention.'}, {'measure': 'Participant evaluation', 'timeFrame': 'During week 7 following intervention initiation', 'description': '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).\n\nItems 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.\n\nItems 15-16: Open-ended questions collecting qualitative feedback.'}, {'measure': 'Semi-structured interviews', 'timeFrame': 'During week 8 following intervention initiation', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'ED behaviours and attitudes: Eating Disorder Examination Questionnaire -(EDE-Q) (Fairburn & Beglin, 1994); Portuguese validated version EDE-Q 5.2. (Machado et al., 2014)', 'timeFrame': 'Baseline (up to one week before the intervention) and Immediately after the intervention (up to one week after the end of the intervention)', 'description': "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)."}, {'measure': 'Perfectionism: Frost Multidimensional Perfectionism Scale (FMPS) (Frost et al., 1990). The Portuguese version of the FMPS validated by Carmo et al. (2017)', 'timeFrame': 'Baseline (up to one week before the intervention) and Immediately after the intervention (up to one week after the end of the intervention)', 'description': '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.'}, {'measure': '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)', 'timeFrame': 'Baseline (up to one week before the intervention) and Immediately after the intervention (up to one week after the end of the intervention)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Feasibility Studies', 'adolescent', 'anorexia nervosa', 'metacognitive training', 'feeding and eating disorders'], 'conditions': ['Anorexia Nervosa', 'Atypical Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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.\n\nPotential 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.\n\nAll 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.\n\nFor 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.\n\nProgression 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescents aged 13 to 19 years;\n* 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;\n* Currently followed in an Eating Disorder Outpatient Consultation;\n* Fluent in Portuguese.\n\nExclusion Criteria:\n\n* Acute suicidal ideation or behaviour requiring immediate clinical intervention;\n* Imminent risk of hospitalization due to clinical deterioration;\n* Current diagnosis of psychotic disorder, bipolar disorder, or substance dependence;\n* Any clinical condition that, in the judgment of the treating clinician, would make participation in a videoconference-based intervention inappropriate.'}, 'identificationModule': {'nctId': 'NCT07435818', 'acronym': 'MCT-ED', 'briefTitle': 'Feasibility and Acceptability of Metacognitive Training for Eating Disorders in Adolescents With Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'University of Évora'}, 'officialTitle': 'Feasibility and Acceptability of Metacognitive Training for Eating Disorders (MCT-ED) in Adolescents With Anorexia Nervosa', 'orgStudyIdInfo': {'id': '2024.15211.DAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metacognitive Training for Eating Disorders + Treatment as usual (TAU)', 'description': 'Adolescents with Anorexia Nervosa ou Atypical Anorexia Nervosa. The adolescent continues to receive any ongoing standard care (treatment as usual, TAU)', 'interventionNames': ['Behavioral: Metacognitive Training for Eating Disorders']}], 'interventions': [{'name': 'Metacognitive Training for Eating Disorders', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Metacognitive Training for Eating Disorders + Treatment as usual (TAU)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Loures', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Andreia Espírito Santo, PhD Student', 'role': 'CONTACT', 'email': 'acj.santo@ensp.unl.pt', 'phone': '00351 21 984 7200'}, {'name': 'Lara Pinho, PhD', 'role': 'CONTACT', 'email': 'l.pinho@ess.ipvc.pt'}, {'name': 'Andreia Espírito Santo, PhD Student', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Beatriz Ângelo - Unidade Local de Saúde Loures-Odivelas, Child and Adolescent Psychiatry Service, Department of Psychiatry and Mental Health, Loures, Portugal', 'geoPoint': {'lat': 38.83091, 'lon': -9.16845}}], 'centralContacts': [{'name': 'Andreia Espírito Santo, PhD Student', 'role': 'CONTACT', 'email': 'acj.santo@ensp.unl.pt', 'phone': '00351219 847 200'}, {'name': 'Lara Pinho, PhD', 'role': 'CONTACT', 'email': 'l.pinho@ess.ipvc.pt'}], 'overallOfficials': [{'name': 'Lara Pinho, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidade de Évora, Comprehensive Health Research Centre (CHRC) LA-REAL, Évora, Portugal'}, {'name': 'Francisco Sampaio', 'role': 'STUDY_CHAIR', 'affiliation': 'Nursing School of the University of Porto, Porto, Portugal'}, {'name': 'Andreia Espírito Santo, PhD Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NOVA National School of Public Health, Comprehensive Health Research Centre, REAL, CCAL, Portugal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Évora', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação para a Ciência e a Tecnologia', 'class': 'OTHER'}, {'name': 'Universidade Nova de Lisboa', 'class': 'OTHER'}, {'name': 'Comprehensive Health Research Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student, Principal Investigator', 'investigatorFullName': 'Andreia Cristina Jales do Espírito Santo', 'investigatorAffiliation': 'University of Évora'}}}}