Metacognitive Interpersonal Therapy Across Transdiagnostic Eating Disorders Including Underweight: Study Protocol for a Single-arm Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Eating Disorder Examination Questionnaire (EDE-Q 6.0; Fairburn & Beglin, 1994)
研究概览
简要总结
The goal of this clinical trial is to assess if Metacognitive Interpersonal Therapy for Eating Disorders (MIT-ED) is effective for treating various forms of Eating Disorders (ED) and reducing dropout rates. The trial will also evaluate its feasibility and outcomes in a patient group including also underweight participants. The main questions it aims to answer are:
- Does MIT-ED improve eating disorder symptoms and reduce overall maintenance factors, as alexithymia, emotional dysregulation, maladaptive perfectionism, and self-esteem?
- Is MIT-ED effective in reducing the severity of personality disorders and associated global psychiatric symptoms?
- What are the dropout rates and adherence levels for patients receiving MIT-ED?
Participants will:
- Undergo an initial screening to confirm eligibility, including a comprehensive clinical interview and assessments based on inclusion and exclusion criteria for the study.
- Receive up to 40 individual sessions of MIT-ED, each lasting 50-60 minutes, over a period of approximately 10-12 months.
- Attend regular assessment focusing on eating disorder symptoms (Eating Disorder Examination Questionnaire, EDE-Q 6.0, and ED Interview, EDE), emotional dysregulation (Difficulties in Emotion Regulation Scale, DERS), alexithymia (Toronto Alexithymia Scale-20, TAS-20), and self-esteem (Rosenberg Self-Esteem Scale, RSES). Assessment will be conducted at baseline (before starting MIT-ED sessions), after 20 MIT-ED sessions (approximately after 5 months), post-treatment (approximately after 10 months), and at 3 months follow-up. A longer 12-months follow-up is planned.
Researchers will evaluate the effectiveness of MIT-ED based on treatment adherence, symptom improvement, and the reduction of maintenance mechanisms associated with Eating Disorders. Positive results could support the design of a larger, controlled Randomized Clinical Trial (RCT).
详细描述
This is a single arm study. The hypotheses are that Metacognitive Interpersonal Therapy for Eating Disorders (MIT-ED) will be able to keep drop-out lower than possible, estimated <20%; promote remission in the primary Eating Disorder (ED) measure; achieve weight gain in underweight participants.
Recruitment will stop once 64 participants have met inclusion criteria and have accepted to participate to the study. The study will recruit adults aged 18 and over, diagnosed with an ED within the past six months, from the Centro di Trattamento Integrato - Disturbi Alimentari e Obesità (CTI-Disturbi Alimentari e Obesità) in Verona and Genova. Underweight individuals will be included to evaluate MIT-ED's broader applicability.
Participants will receive up to 40 individual sessions of MIT-ED, delivered either in-person or via videoconferencing by 3 trained therapists. Therapists will receive 2 hours supervision every two weeks with 2 of Metacognitive Interpersonal Therapy designers. Therapy sessions will be randomly audio-recorded for process analysis Assessments will occur at baseline, after 20 MIT-ED sessions (approximately after 5 months), post-treatment (approximately after 10 months), and at 3 months follow-up, where publications of the results are scheduled. A longer term 12-months follow-up is planned. A research assistant will handle psychometric test administration and coordination with the clinical team.
This study will provide preliminary evidence on the feasibility and effectiveness of MIT-ED in a broader ED population, including underweight patients. The results will inform the design of a larger controlled trials to further validate MIT-ED efficacy with the hope it results as a new treatment option for patients with transdiagnostic ED.
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
盲法说明
Treatment-seeking participants will first receive an assessment screening visit. Once evaluated for inclusion/exclusion criteria, and informed written consent has been obtained, baseline measures about primary and secondary outcomes will be completed. Participants will then be proposed for inclusion in the study.
Recruitment will stop once 64 participants have met inclusion criteria and have accepted to participate to the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult outpatients (from age 18 years)
- •Having an Eating Disorder for which they required treatment
- •BMI between 17.5 and 40
- •Provision of informed consent
排除标准
- •Receiving ongoing psychiatric, other psychotherapeutic treatment
- •Coexisting psychiatric disorders precludeing eating disorder-focused treatment or that requires specialized treatment: bipolar I, psychosis, alcohol or substance abuse, suicidality. PTSD is an exclusion criteria as long as its symptoms as prominent so to require a specialized empirically supported treatment
- •Intellectual disability
研究组 & 干预措施
Experimental: MIT-ED
Participants will receive 1 or 2 preliminary sessions focused on typical elements of Cognitive Behavioral Therapy for Eating Disorders, including psychoeducational training on eating behaviors, an introduction to tools such as monitoring forms, weight charts, and assessments of eating behaviors like physical exercise, body checking, and episodes of binging, purging, and starvation. Before treatment starts, patients meet with a dietitian to develop a nutritional plan that normalizes calorie intake, which will be reviewed throughout treatment. After these sessions, participants will receive up to 40 weekly individual sessions.
Given the inclusion of underweight patients, the protocol developed by Fioravanti and colleagues (2023) required adaptations, such as considering the effects of malnutrition on cognitive and organic functioning and extending psychotherapy for up to 40 sessions.
干预措施: MIT-ED (Other)
结局指标
主要结局
Eating Disorder Examination Questionnaire (EDE-Q 6.0; Fairburn & Beglin, 1994)
时间窗: Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).
A self report measure assessing eating disorders over the past 4 weeks, providing a measure of the range of severity of eating disorder features. The questionnaire consists of 28 items with responses ranging from 0 to 6 (where 6 indicates higher gravity of the disorder).
Eating Disorder Examination Interview (EDE, Fairburn, Cooper & O'Connor; 2014).
时间窗: Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).
An interview based on the Eating Disorder Examination Questionnaire-6 questionnaire, which provides information about the main behavioural characteristics of eating disorders. Questions concern the frequency in which the patient engages in behaviors indicative of an eating disorder over a 28-day period. The test is scored on a 7-point scale from 0-6. With a zero score indicating not having engaged in the questioned behavior.
次要结局
- Binge Eating Scale (BES; Gormally et al., 1992)(Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).)
- Body Mass Index (BMI)(Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).)
- Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Disorders (SCID-5; Michael B. First, Janet B.W. Williams)(At baseline and after 20 sessions of therapy (approximately after 5 months))
- Symptom Check List (SCL-90)(Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).)
- Toronto Alexithymia Scale (TAS - 20; Taylor & Bagby, 1992)(Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).)
- Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)(Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).)
- Multidimensional Perfectionism Scale (MPS; Hewitt & Flett, 2004)(Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).)
- Perfectionistic Cognitions Inventory (PCI; Flett, Hewitt, Blankstein & Gray, 1998)(Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).)
- Rosenberg Self-Exteem Scale (RSES; Rosenberg, 1965)(Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).)
研究者
GLORIA FIORAVANTI
Gloria Fioravanti
Centro Trattamento Integrato: Disturbi Alimentari e Obesita