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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Anorexia Nervosa; Anorexia
• Intervention / Treatment: Behavioral: MANTR-a treatment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna, Dep. of Child and Adolescent Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: MANTR-a treatment; MANTR-a treatment
No Intervention: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Pharmig - Gesundheitsziele aus dem Rahmen-Pharmavertrag
• Investigators: Study Director: Andreas Karwautz, Univ.-Prof., Medical University of Vienna; Study Director: Gudrun Wagner, Ass.-Prof., Medical University of Vienna

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: March 28, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Treatment; Adolescence; Psychotherapy; Young Adult
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: FA765A0306

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No