MANTR-a: Evaluation of a Therapeutic Intervention for Adolescents and Young Adults With Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Improvement of eating disorder symptomatology based on professional's rating
研究概览
简要总结
The aim of this study is to test effectiveness of a new treatment program for adolescents and young adults within the age of 14-21 suffering from AN (MANTR-a) compared to treatment as usual (TAU).
详细描述
Anorexia nervosa (AN) is a serious mental illness which leads untreated to aggravation of symptomatology and chronification. Among all mental illnesses, AN has the highest mortality rate, which is about 5.1 per 1000 people per year. High drop-out rates (up to 40%) or small treatment motivation constrains treatment success. Since the onset of AN is mainly in adolescence, it is important to start with therapy as early as possible and establish an effective single-setting treatment program for this age group to prevent chronification.
MANTR-a (Maudsley model of anorexia nervosa treatment for adolescents) is an innovative, theory-based, tailored treatment program which combines a cognitive behavioural approach with motivational interviewing. The main focus of the treatment program is the transformation maintaining factors of AN, like personality aspects, pro-anorexic beliefs, emotion regulation strategies, thinking styles and obstructive behaviour from caregivers.
The aim of this study is the examination ot the effectiveness of the MANTR-a treatment program for adolescents and young adults. Therefore we compare MANTR-a (intervention group) with treatment as usual (control group). Assessments will be conducted before treatment (T0, baseline), after six months (T1), after 12 months (T2) and after 18 months (T3, follow-up) via questionnaires, interviews and neuropsychological measurements. Process evaluation takes place after every session. Each group consists of female adolescents and young adults within the age of 14-21 suffering from AN (ICD-10: F50.0, F50.1), resulting in an overall sample size of 100.
The long-term goal of the study is to provide an evidence-based outpatient treatment for children and adolescents with AN in order to prevent a chronic course of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 21 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ICD-10 diagnosis of anorexia nervosa (F50.0) or atypical anorexia nervosa (F50.1).
排除标准
- •life-threatening AN requiring immediate inpatient treatment as defined by NICE (2017)
- •insufficient cognitive ability
- •insufficient knowledge of German language to understand the treatment
- •severe mental or physical illness that needs treatment on its own (e.g. psychosis)
- •substance abuse
- •pregnancy
研究组 & 干预措施
MANTR-a group
Patients who are in the MANTR-a group attend the MANTR-a treatment program, which consists of 20 once-weekly therapy sessions. Caregivers can be invited to 2 sessions. After 20 weeks, therapy continues with four monthly booster-sessions. In sum, each patient (whose bodyweight is above the 3rd BMI percentile) can attend 24 therapy sessions. In patients whose bodyweight is below the 3rd BMI percentile treatment will be extended to 30 once-weekly and 4 monthly booster sessions. Besides therapy the patients are in nutritional consultation by a dietician and under regular medical care to monitor the physical health and weight gain.
Patients who who have already an existing psychotherapy are attached to the control group.
干预措施: MANTR-a treatment (Behavioral)
control group
Patients of the control group receive treatment as usual (TAU). It consists of medical care and monitoring, psychotherapy in a single or family setting, parents counselling and dietetics.
结局指标
主要结局
Improvement of eating disorder symptomatology based on professional's rating
时间窗: 12 months
Professionals use a structured clinical interview ("Eating Disorder Examination - EDE") to rate severity of eating disorder symptomatology
Increase of BMI
时间窗: 12 months
Weight and height will be assessed and combined to report BMI in kg/m\^2
Improvement of eating disorder symptomatology based on patient's self-rating
时间窗: 12 months
"Eating Disorder Inventory-2 (EDI-2)" is used to assess eating disorder symptomatology from a patients's view
次要结局
- Improvement of eating disorder symptomatology based on patient's self-rating(6 months, 18 months)
- Increase of BMI(6 months, 18 months)
- Group differences: improvement of eating disorder symptomatology based on patient's self-rating(6 months, 12 months, 18 months)
- Reduction of depression(6 months, 12 months, 18 months)
- Quality of life (group differences, improvement over time)(6 months, 12 months, 18 months)
- Improvement of comorbid symptomatology based on professional's rating(6 months, 12 months, 18 months)
- Increase of central coherence(12 months)
- Increase of emotion recognition(12 months)
- Influence of motivation of change(12 months)
- Influence of treatment contentment(6 months, 12 months)
- Improvement of eating disorder symptomatology based on professional's rating(6 months, 18 months)
- Reduction of obsessive-compulsive symptomatology(6 months, 12 months, 18 months)
- Group differences: improvement of eating disorder symptomatology based on professional's rating(6 months, 12 months, 18 months)
- Group differences: increase of BMI(6 months, 12 months, 18 months)
- Reduction of anxiety(6 months, 12 months, 18 months)
- Increase of cognitive flexibility(12 months)
- Influence of therapeutic relationship(6 months, 12 months)
- Changes in personality(12 months)
研究者
Dr. Andreas Karwautz
Univ. Prof. Dr.
Medical University of Vienna