Maudsley Model of Anorexia Nervosa Treatment for Adolescents and Young Adults (MANTR-a)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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MANTR-a: Evaluation of a Therapeutic Intervention for Adolescents and Young Adults With Anorexia Nervosa

Conditions
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Anorexia Nervosa, Anorexia

Intervention / Treatment
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* Behavioral: MANTR-a treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICD-10 diagnosis of anorexia nervosa (F50.0) or atypical anorexia nervosa (F50.1). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MANTR-a group<br>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. | Behavioral: MANTR-a treatment<br>* MANTR-a treatment<br>|
| No Intervention: control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of BMI | Weight and height will be assessed and combined to report BMI in kg/m^2 | 12 months | 
| Improvement of eating disorder symptomatology based on professional's rating | Professionals use a structured clinical interview (Eating Disorder Examination - EDE) to rate severity of eating disorder symptomatology | 12 months | 
| Improvement of eating disorder symptomatology based on patient's self-rating | Eating Disorder Inventory-2 (EDI-2) is used to assess eating disorder symptomatology from a patients's view | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of BMI | Weight and height will be assessed and combined to report BMI in kg/m^2 | 6 months, 18 months | 
| Improvement of eating disorder symptomatology based on professional's rating | Professionals use a structured clinical interview (Eating Disorder Examination - EDE) to rate severity of eating disorder symptomatology | 6 months, 18 months | 
| Improvement of eating disorder symptomatology based on patient's self-rating | Eating Disorder Inventory-2 (EDI-2) is used to assess eating disorder symptomatology from a patients's view | 6 months, 18 months | 
| Group differences: increase of BMI | Group differences are calculated based on BMI (weight and height will be assessed and combined to report BMI in kg/m^2) | 6 months, 12 months, 18 months | 
| Group differences: improvement of eating disorder symptomatology based on professional's rating | Group differences are calculated based on professional's rating in a structured clinical interview (Eating Disorder Examination - EDE) | 6 months, 12 months, 18 months | 
| Group differences: improvement of eating disorder symptomatology based on patient's self-rating | Group differences are calculated based on a patient's self-rating questionnaire (Eating Disorder Inventory-2) | 6 months, 12 months, 18 months | 
| Improvement of comorbid symptomatology based on professional's rating | Professionals use a structured clinical interview (Diagnostisches Interview bei psychischen Störungen im Kindes- und Jugendalter) to rate severity of comorbid symptomatology | 6 months, 12 months, 18 months | 
| Reduction of anxiety | State-Trait-Angstinventar (STAI X1, STAI X2) is used to assess severity of anxiety from a patients's view | 6 months, 12 months, 18 months | 
| Reduction of depression | Beck Depressionsinventar (BDI-II) is used to assess severity of depression from a patients's view | 6 months, 12 months, 18 months | 
| Reduction of obsessive-compulsive symptomatology | Zwangsinventar (OCI-R) is used to assess severity of obsessive-compulsive symptomatology from a patients's view | 6 months, 12 months, 18 months | 
| Increase of cognitive flexibility | Cognitive flexibility is measured with Computergestütztes Kartensortierverfahren (CKV) | 12 months | 
| Increase of central coherence | Central coherence is measured with Rey-Osterrieth Complex Figure Test (ROCF) | 12 months | 
| Increase of emotion recognition | Emotion recognition is measured with Frankfurter Program to test and to teach the recognition of facial affect (FEFA-2) | 12 months | 
| Influence of motivation of change | Motivation of change is measured with Anorexia nervosa Stages of Change Questionnaire (ANSOCQ) | 12 months | 
| Quality of life (group differences, improvement over time) | Quality of Life is measured with Lebensqualität von Kindern und Jugendlichen (ILK) | 6 months, 12 months, 18 months | 
| Influence of therapeutic relationship | Therapeutic relationship is measured with Fragebogen zur therapeutischen Beziehung für Kinder und Jugendliche (FTB-KJ) | 6 months, 12 months | 
| Influence of treatment contentment | Treatment contentment is measured with Fragebogen zur Beurteilung der Behandlung (FBB) | 6 months, 12 months | 
| Changes in personality | Changes in personality are measured with Junior Temperament und Charakter Inventar (JTCI 12-18R) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment, Psychotherapy, Young Adult, Adolescence