An interventional study of MANTR-a treatment in Anorexia Nervosa and Anorexia, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to female participants aged 14 Years to 21 Years. Per ClinicalTrials.gov, last updated 2021-03-05.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment
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).
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.
411 studies on the registry are indexed under Anorexia; 67 are open to participants now.
This study's planned enrollment of 100 is above the median of 41 across 287 interventional studies indexed under Anorexia.
Browse Anorexia studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
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Exclusion Criteria:
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
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.
MANTR-a treatment
Increase of BMI
Weight and height will be assessed and combined to report BMI in kg/m\^2
Time frame: 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
Time frame: 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
Time frame: 12 months
Increase of BMI
Weight and height will be assessed and combined to report BMI in kg/m\^2
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)"
Time frame: 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")
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months, 12 months, 18 months
Increase of cognitive flexibility
Cognitive flexibility is measured with "Computergestütztes Kartensortierverfahren (CKV)"
Time frame: 12 months
Increase of central coherence
Central coherence is measured with "Rey-Osterrieth Complex Figure Test (ROCF)"
Time frame: 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)"
Time frame: 12 months
Influence of motivation of change
Motivation of change is measured with "Anorexia nervosa Stages of Change Questionnaire (ANSOCQ)"
Time frame: 12 months
Quality of life (group differences, improvement over time)
Quality of Life is measured with "Lebensqualität von Kindern und Jugendlichen (ILK)"
Time frame: 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)"
Time frame: 6 months, 12 months
Influence of treatment contentment
Treatment contentment is measured with "Fragebogen zur Beurteilung der Behandlung (FBB)"
Time frame: 6 months, 12 months
Changes in personality
Changes in personality are measured with "Junior Temperament und Charakter Inventar (JTCI 12-18R)"
Time frame: 12 months
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna