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

Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03535714
• Other study ID #: FA765A0306
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 25, 2018
• Est. completion date: August 31, 2022

Study information

• Verified date: March 2021
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: August 31, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Behavioral:
• MANTR-a treatment
MANTR-a treatment

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Dep. of Child and Adolescent Psychiatry	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Pharmig - Gesundheitsziele aus dem Rahmen-Pharmavertrag

Country where clinical trial is conducted

Austria, 

References & Publications (4)

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. — View 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. Review. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase of BMI	Weight and height will be assessed and combined to report BMI in kg/m^2	12 months
Primary	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
Primary	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	Increase of BMI	Weight and height will be assessed and combined to report BMI in kg/m^2	6 months, 18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Increase of cognitive flexibility	Cognitive flexibility is measured with "Computergestütztes Kartensortierverfahren (CKV)"	12 months
Secondary	Increase of central coherence	Central coherence is measured with "Rey-Osterrieth Complex Figure Test (ROCF)"	12 months
Secondary	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
Secondary	Influence of motivation of change	Motivation of change is measured with "Anorexia nervosa Stages of Change Questionnaire (ANSOCQ)"	12 months
Secondary	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
Secondary	Influence of therapeutic relationship	Therapeutic relationship is measured with "Fragebogen zur therapeutischen Beziehung für Kinder und Jugendliche (FTB-KJ)"	6 months, 12 months
Secondary	Influence of treatment contentment	Treatment contentment is measured with "Fragebogen zur Beurteilung der Behandlung (FBB)"	6 months, 12 months
Secondary	Changes in personality	Changes in personality are measured with "Junior Temperament und Charakter Inventar (JTCI 12-18R)"	12 months