Feasibility and Acceptability of Metacognitive Training for Eating Disorders (MCT-ED) in Adolescents With Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Metacognitive Training for Eating Disorders + Treatment as usual (TAU)
Adolescents with Anorexia Nervosa ou Atypical Anorexia Nervosa. The adolescent continues to receive any ongoing standard care (treatment as usual, TAU)
干预措施: Metacognitive Training for Eating Disorders (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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))
研究者
Andreia Cristina Jales do Espírito Santo
PhD Student, Principal Investigator
University of Évora