Clinical trial NCT03535714: Maudsley Model of Anorexia Nervosa Treatment for Adolescents and Young Adults (MANTR-a)
Official title: MANTR-a: Evaluation of a Therapeutic Intervention for Adolescents and Young Adults With Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anorexia Nervosa
Anorexia
Keywords: Treatment
Psychotherapy
Young Adult
Adolescence
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Pharmig - Gesundheitsziele aus dem Rahmen-Pharmavertrag
First posted: 2018-05-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Increase of BMI
timeFrame: 12 months
measure: Improvement of eating disorder symptomatology based on professional's rating
timeFrame: 12 months
measure: Improvement of eating disorder symptomatology based on patient's self-rating
timeFrame: 12 months
Secondary outcomes:
measure: Increase of BMI
timeFrame: 6 months, 18 months
measure: Improvement of eating disorder symptomatology based on professional's rating
timeFrame: 6 months, 18 months
measure: Improvement of eating disorder symptomatology based on patient's self-rating
timeFrame: 6 months, 18 months
measure: Group differences: increase of BMI
timeFrame: 6 months, 12 months, 18 months
measure: Group differences: improvement of eating disorder symptomatology based on professional's rating
timeFrame: 6 months, 12 months, 18 months
measure: Group differences: improvement of eating disorder symptomatology based on patient's self-rating
timeFrame: 6 months, 12 months, 18 months
measure: Improvement of comorbid symptomatology based on professional's rating
timeFrame: 6 months, 12 months, 18 months
measure: Reduction of anxiety
timeFrame: 6 months, 12 months, 18 months
measure: Reduction of depression
timeFrame: 6 months, 12 months, 18 months
measure: Reduction of obsessive-compulsive symptomatology
timeFrame: 6 months, 12 months, 18 months
measure: Increase of cognitive flexibility
timeFrame: 12 months
measure: Increase of central coherence
timeFrame: 12 months
measure: Increase of emotion recognition
timeFrame: 12 months
measure: Influence of motivation of change
timeFrame: 12 months
measure: Quality of life (group differences, improvement over time)
timeFrame: 6 months, 12 months, 18 months
measure: Influence of therapeutic relationship
timeFrame: 6 months, 12 months
measure: Influence of treatment contentment
timeFrame: 6 months, 12 months
measure: Changes in personality
timeFrame: 12 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Dep. of Child and Adolescent Psychiatry
Study officials:
affiliation: Medical University of Vienna
name: Andreas Karwautz, Univ.-Prof.
role: STUDY_DIRECTOR
affiliation: Medical University of Vienna
name: Gudrun Wagner, Ass.-Prof.
role: STUDY_DIRECTOR
References:
citation: Arcelus J, Mitchell AJ, Wales J, Nielsen S. Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies. Arch Gen Psychiatry. 2011 Jul;68(7):724-31. doi: 10.1001/archgenpsychiatry.2011.74.
citation: Dejong H, Broadbent H, Schmidt U. A systematic review of dropout from treatment in outpatients with anorexia nervosa. Int J Eat Disord. 2012 Jul;45(5):635-47. doi: 10.1002/eat.20956. Epub 2011 Aug 30.
citation: Schmidt U, Treasure J. Anorexia nervosa: valued and visible. A cognitive-interpersonal maintenance model and its implications for research and practice. Br J Clin Psychol. 2006 Sep;45(Pt 3):343-66. doi: 10.1348/014466505x53902.
citation: Treasure J, Schmidt U. The cognitive-interpersonal maintenance model of anorexia nervosa revisited: a summary of the evidence for cognitive, socio-emotional and interpersonal predisposing and perpetuating factors. J Eat Disord. 2013 Apr 15;1:13. doi: 10.1186/2050-2974-1-13. eCollection 2013.
citation: Wittek T, Truttmann S, Zeiler M, Philipp J, Auer-Welsbach E, Koubek D, Ohmann S, Werneck-Rohrer S, Sackl-Pammer P, Schofbeck G, Mairhofer D, Kahlenberg L, Schmidt U, Karwautz AFK, Wagner G. The Maudsley model of anorexia nervosa treatment for adolescents and young adults (MANTRa): a study protocol for a multi-center cohort study. J Eat Disord. 2021 Mar 8;9(1):33. doi: 10.1186/s40337-021-00387-8.