search
Back to results

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

Primary Purpose

Anorexia Nervosa, Anorexia

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
MANTR-a treatment
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Treatment, Psychotherapy, Young Adult, Adolescence

Eligibility Criteria

14 Years - 21 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

MANTR-a group

control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Increase of BMI
Weight and height will be assessed and combined to report BMI in kg/m^2
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
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

Secondary Outcome Measures

Increase of BMI
Weight and height will be assessed and combined to report BMI in kg/m^2
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
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
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)
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)"
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")
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
Reduction of anxiety
"State-Trait-Angstinventar (STAI X1, STAI X2)" is used to assess severity of anxiety from a patients's view
Reduction of depression
"Beck Depressionsinventar (BDI-II)" is used to assess severity of depression from a patients's view
Reduction of obsessive-compulsive symptomatology
"Zwangsinventar (OCI-R)" is used to assess severity of obsessive-compulsive symptomatology from a patients's view
Increase of cognitive flexibility
Cognitive flexibility is measured with "Computergestütztes Kartensortierverfahren (CKV)"
Increase of central coherence
Central coherence is measured with "Rey-Osterrieth Complex Figure Test (ROCF)"
Increase of emotion recognition
Emotion recognition is measured with "Frankfurter Program to test and to teach the recognition of facial affect (FEFA-2)"
Influence of motivation of change
Motivation of change is measured with "Anorexia nervosa Stages of Change Questionnaire (ANSOCQ)"
Quality of life (group differences, improvement over time)
Quality of Life is measured with "Lebensqualität von Kindern und Jugendlichen (ILK)"
Influence of therapeutic relationship
Therapeutic relationship is measured with "Fragebogen zur therapeutischen Beziehung für Kinder und Jugendliche (FTB-KJ)"
Influence of treatment contentment
Treatment contentment is measured with "Fragebogen zur Beurteilung der Behandlung (FBB)"
Changes in personality
Changes in personality are measured with "Junior Temperament und Charakter Inventar (JTCI 12-18R)"

Full Information

First Posted
March 28, 2018
Last Updated
March 3, 2021
Sponsor
Medical University of Vienna
Collaborators
Pharmig - Gesundheitsziele aus dem Rahmen-Pharmavertrag
search

1. Study Identification

Unique Protocol Identification Number
NCT03535714
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
Pharmig - Gesundheitsziele aus dem Rahmen-Pharmavertrag

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Anorexia
Keywords
Treatment, Psychotherapy, Young Adult, Adolescence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MANTR-a group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MANTR-a treatment
Intervention Description
MANTR-a treatment
Primary Outcome Measure Information:
Title
Increase of BMI
Description
Weight and height will be assessed and combined to report BMI in kg/m^2
Time Frame
12 months
Title
Improvement of eating disorder symptomatology based on professional's rating
Description
Professionals use a structured clinical interview ("Eating Disorder Examination - EDE") to rate severity of eating disorder symptomatology
Time Frame
12 months
Title
Improvement of eating disorder symptomatology based on patient's self-rating
Description
"Eating Disorder Inventory-2 (EDI-2)" is used to assess eating disorder symptomatology from a patients's view
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Increase of BMI
Description
Weight and height will be assessed and combined to report BMI in kg/m^2
Time Frame
6 months, 18 months
Title
Improvement of eating disorder symptomatology based on professional's rating
Description
Professionals use a structured clinical interview ("Eating Disorder Examination - EDE") to rate severity of eating disorder symptomatology
Time Frame
6 months, 18 months
Title
Improvement of eating disorder symptomatology based on patient's self-rating
Description
"Eating Disorder Inventory-2 (EDI-2)" is used to assess eating disorder symptomatology from a patients's view
Time Frame
6 months, 18 months
Title
Group differences: increase of BMI
Description
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
Title
Group differences: improvement of eating disorder symptomatology based on professional's rating
Description
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
Title
Group differences: improvement of eating disorder symptomatology based on patient's self-rating
Description
Group differences are calculated based on a patient's self-rating questionnaire ("Eating Disorder Inventory-2")
Time Frame
6 months, 12 months, 18 months
Title
Improvement of comorbid symptomatology based on professional's rating
Description
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
Title
Reduction of anxiety
Description
"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
Title
Reduction of depression
Description
"Beck Depressionsinventar (BDI-II)" is used to assess severity of depression from a patients's view
Time Frame
6 months, 12 months, 18 months
Title
Reduction of obsessive-compulsive symptomatology
Description
"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
Title
Increase of cognitive flexibility
Description
Cognitive flexibility is measured with "Computergestütztes Kartensortierverfahren (CKV)"
Time Frame
12 months
Title
Increase of central coherence
Description
Central coherence is measured with "Rey-Osterrieth Complex Figure Test (ROCF)"
Time Frame
12 months
Title
Increase of emotion recognition
Description
Emotion recognition is measured with "Frankfurter Program to test and to teach the recognition of facial affect (FEFA-2)"
Time Frame
12 months
Title
Influence of motivation of change
Description
Motivation of change is measured with "Anorexia nervosa Stages of Change Questionnaire (ANSOCQ)"
Time Frame
12 months
Title
Quality of life (group differences, improvement over time)
Description
Quality of Life is measured with "Lebensqualität von Kindern und Jugendlichen (ILK)"
Time Frame
6 months, 12 months, 18 months
Title
Influence of therapeutic relationship
Description
Therapeutic relationship is measured with "Fragebogen zur therapeutischen Beziehung für Kinder und Jugendliche (FTB-KJ)"
Time Frame
6 months, 12 months
Title
Influence of treatment contentment
Description
Treatment contentment is measured with "Fragebogen zur Beurteilung der Behandlung (FBB)"
Time Frame
6 months, 12 months
Title
Changes in personality
Description
Changes in personality are measured with "Junior Temperament und Charakter Inventar (JTCI 12-18R)"
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Karwautz, Univ.-Prof.
Organizational Affiliation
Medical University of Vienna
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gudrun Wagner, Ass.-Prof.
Organizational Affiliation
Medical University of Vienna
Official's Role
Study Director
Facility Information:
Facility Name
Medical University of Vienna, Dep. of Child and Adolescent Psychiatry
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
21727255
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.
Results Reference
background
PubMed Identifier
22684990
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.
Results Reference
background
PubMed Identifier
17147101
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.
Results Reference
background
PubMed Identifier
24999394
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.
Results Reference
background
PubMed Identifier
33685522
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs