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

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ClinicalTrials.gov Identifier: NCT03535714
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : June 15, 2018
Sponsor:
Collaborator:
Pharmig - Gesundheitsziele aus dem Rahmen-Pharmavertrag
Information provided by (Responsible Party):
Dr. Andreas Karwautz, Medical University of Vienna

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).

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Anorexia Behavioral: MANTR-a treatment Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MANTR-a: Evaluation of a Therapeutic Intervention for Adolescents and Young Adults With Anorexia Nervosa
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

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.



Primary Outcome Measures :
  1. Increase of BMI [ Time Frame: 6 months, 12 months, 18 months ]
    Weight and height will be assessed and combined to report BMI in kg/m^2

  2. Improvement of eating disorder symptomatology based on professional's rating [ Time Frame: 6 months, 12 months, 18 months ]
    Professionals use a structured clinical interview ("Eating Disorder Examination - EDE") to rate severity of eating disorder symptomatology

  3. Improvement of eating disorder symptomatology based on patient's self-rating [ Time Frame: 6 months, 12 months, 18 months ]
    "Eating Disorder Inventory-2 (EDI-2)" is used to assess eating disorder symptomatology from a patients's view


Secondary Outcome Measures :
  1. Group differences: increase of BMI [ Time Frame: 6 months, 12 months, 18 months ]
    Group differences are calculated based on BMI (weight and height will be assessed and combined to report BMI in kg/m^2)

  2. Group differences: improvement of eating disorder symptomatology based on professional's rating [ Time Frame: 6 months, 12 months, 18 months ]
    Group differences are calculated based on professional's rating in a structured clinical interview ("Eating Disorder Examination - EDE)"

  3. Group differences: improvement of eating disorder symptomatology based on patient's self-rating [ Time Frame: 6 months, 12 months, 18 months ]
    Group differences are calculated based on a patient's self-rating questionnaire ("Eating Disorder Inventory-2")

  4. Improvement of comorbid symptomatology based on professional's rating [ Time Frame: 6 months, 12 months, 18 months ]
    Professionals use a structured clinical interview ("Diagnostisches Interview bei psychischen Störungen im Kindes- und Jugendalter") to rate severity of comorbid symptomatology

  5. Reduction of anxiety [ Time Frame: 6 months, 12 months, 18 months ]
    "State-Trait-Angstinventar (STAI X1, STAI X2)" is used to assess severity of anxiety from a patients's view

  6. Reduction of depression [ Time Frame: 6 months, 12 months, 18 months ]
    "Beck Depressionsinventar (BDI-II)" is used to assess severity of depression from a patients's view

  7. Reduction of obsessive-compulsive symptomatology [ Time Frame: 6 months, 12 months, 18 months ]
    "Zwangsinventar (OCI-R)" is used to assess severity of obsessive-compulsive symptomatology from a patients's view

  8. Increase of cognitive flexibility [ Time Frame: 12 months ]
    Cognitive flexibility is measured with "Computergestütztes Kartensortierverfahren (CKV)"

  9. Increase of central coherence [ Time Frame: 12 months ]
    Central coherence is measured with "Rey-Osterrieth Complex Figure Test (ROCF)"

  10. Increase of emotion recognition [ Time Frame: 12 months ]
    Emotion recognition is measured with "Frankfurter Program to test and to teach the recognition of facial affect (FEFA-2)"

  11. Influence of motivation of change [ Time Frame: 12 months ]
    Motivation of change is measured with "Anorexia nervosa Stages of Change Questionnaire (ANSOCQ)"

  12. Quality of life (group differences, improvement over time) [ Time Frame: 6 months, 12 months, 18 months ]
    Quality of Life is measured with "Lebensqualität von Kindern und Jugendlichen (ILK)"

  13. Influence of therapeutic relationship [ Time Frame: 6 months, 12 months ]
    Therapeutic relationship is measured with "Fragebogen zur therapeutischen Beziehung für Kinder und Jugendliche (FTB-KJ)"

  14. Influence of treatment contentment [ Time Frame: 6 months, 12 months ]
    Treatment contentment is measured with "Fragebogen zur Beurteilung der Behandlung (FBB)"

  15. Changes in personality [ Time Frame: 12 months ]
    Changes in personality are measured with "Junior Temperament und Charakter Inventar (JTCI 12-18R)"



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Ages Eligible for Study:   14 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535714


Contacts
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Contact: Andreas Karwautz, Univ.-Prof. 0043 1 40400 ext 30310 andreas.karwautz@meduniwien.ac.at
Contact: Gudrun Wagner, Ass.-Prof. 0043 1 40400 ext 30170 gudrun.wagner@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna, Dep. of Child and Adolescent Psychiatry Recruiting
Vienna, Austria, 1090
Contact: Andreas Karwautz, MD, Prof    0043 1 40400 ext 30570    andreas.karwautz@meduniwien.ac.at   
Contact: Gudrun Wagner, Mag, Dr    0043 1 40400 ext 30170    gudrun.wagner@meduniwien.ac.at   
Principal Investigator: Andreas Karwautz, MD, Prof         
Sub-Investigator: Gudrun Wagner, Mag, Dr         
Sponsors and Collaborators
Medical University of Vienna
Pharmig - Gesundheitsziele aus dem Rahmen-Pharmavertrag
Investigators
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Study Director: Andreas Karwautz, Univ.-Prof. Medical University of Vienna
Study Director: Gudrun Wagner, Ass.-Prof. Medical University of Vienna

Publications:
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Responsible Party: Dr. Andreas Karwautz, Univ. Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03535714     History of Changes
Other Study ID Numbers: FA765A0306
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Andreas Karwautz, Medical University of Vienna:
Treatment
Psychotherapy
Young Adult
Adolescence

Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders