Maudsley Model of Anorexia Nervosa Treatment for Adolescents and Young Adults (MANTR-a)
- Conditions
- Anorexia NervosaAnorexia
- Interventions
- Behavioral: MANTR-a treatment
- Registration Number
- NCT03535714
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
- ICD-10 diagnosis of anorexia nervosa (F50.0) or atypical anorexia nervosa (F50.1).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MANTR-a group MANTR-a treatment 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.
- Primary Outcome Measures
Name Time Method Improvement of eating disorder symptomatology based on professional's rating 12 months Professionals use a structured clinical interview ("Eating Disorder Examination - EDE") to rate severity of eating disorder symptomatology
Increase of BMI 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 12 months "Eating Disorder Inventory-2 (EDI-2)" is used to assess eating disorder symptomatology from a patients's view
- Secondary Outcome Measures
Name Time Method Increase of BMI 6 months, 18 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 6 months, 18 months "Eating Disorder Inventory-2 (EDI-2)" is used to assess eating disorder symptomatology from a patients's view
Group differences: improvement of eating disorder symptomatology based on patient's self-rating 6 months, 12 months, 18 months Group differences are calculated based on a patient's self-rating questionnaire ("Eating Disorder Inventory-2")
Reduction of depression 6 months, 12 months, 18 months "Beck Depressionsinventar (BDI-II)" is used to assess severity of depression from a patients's view
Quality of life (group differences, improvement over time) 6 months, 12 months, 18 months Quality of Life is measured with "Lebensqualität von Kindern und Jugendlichen (ILK)"
Improvement of comorbid symptomatology based on professional's rating 6 months, 12 months, 18 months Professionals use a structured clinical interview ("Diagnostisches Interview bei psychischen Störungen im Kindes- und Jugendalter") to rate severity of comorbid symptomatology
Increase of central coherence 12 months Central coherence is measured with "Rey-Osterrieth Complex Figure Test (ROCF)"
Increase of emotion recognition 12 months Emotion recognition is measured with "Frankfurter Program to test and to teach the recognition of facial affect (FEFA-2)"
Influence of motivation of change 12 months Motivation of change is measured with "Anorexia nervosa Stages of Change Questionnaire (ANSOCQ)"
Influence of treatment contentment 6 months, 12 months Treatment contentment is measured with "Fragebogen zur Beurteilung der Behandlung (FBB)"
Improvement of eating disorder symptomatology based on professional's rating 6 months, 18 months Professionals use a structured clinical interview ("Eating Disorder Examination - EDE") to rate severity of eating disorder symptomatology
Reduction of obsessive-compulsive symptomatology 6 months, 12 months, 18 months "Zwangsinventar (OCI-R)" is used to assess severity of obsessive-compulsive symptomatology from a patients's view
Group differences: improvement of eating disorder symptomatology based on professional's rating 6 months, 12 months, 18 months Group differences are calculated based on professional's rating in a structured clinical interview ("Eating Disorder Examination - EDE)"
Group differences: increase of BMI 6 months, 12 months, 18 months Group differences are calculated based on BMI (weight and height will be assessed and combined to report BMI in kg/m\^2)
Reduction of anxiety 6 months, 12 months, 18 months "State-Trait-Angstinventar (STAI X1, STAI X2)" is used to assess severity of anxiety from a patients's view
Increase of cognitive flexibility 12 months Cognitive flexibility is measured with "Computergestütztes Kartensortierverfahren (CKV)"
Influence of therapeutic relationship 6 months, 12 months Therapeutic relationship is measured with "Fragebogen zur therapeutischen Beziehung für Kinder und Jugendliche (FTB-KJ)"
Changes in personality 12 months Changes in personality are measured with "Junior Temperament und Charakter Inventar (JTCI 12-18R)"
Trial Locations
- Locations (1)
Medical University of Vienna, Dep. of Child and Adolescent Psychiatry
🇦🇹Vienna, Austria