NCT03535714

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

April 25, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

3.8 years

First QC Date

March 28, 2018

Last Update Submit

March 3, 2021

Conditions

Anorexia NervosaAnorexia

Keywords

TreatmentPsychotherapyYoung AdultAdolescence

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (18)

  • Increase of BMI

    6 months, 18 months

  • Improvement of eating disorder symptomatology based on professional's rating

    6 months, 18 months

  • Improvement of eating disorder symptomatology based on patient's self-rating

    6 months, 18 months

  • Group differences: increase of BMI

    6 months, 12 months, 18 months

  • Group differences: improvement of eating disorder symptomatology based on professional's rating

    6 months, 12 months, 18 months

  • +13 more secondary outcomes

Study Arms (2)

MANTR-a group

ACTIVE COMPARATOR

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

control group

NO INTERVENTION

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.

Interventions

MANTR-a treatmentBEHAVIORAL

MANTR-a treatment

MANTR-a group

Eligibility Criteria

Age14 Years - 21 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ICD-10 diagnosis of anorexia nervosa (F50.0) or atypical anorexia nervosa (F50.1).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vienna, 1090, Austria

Location

Related Publications (6)

  • 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.

    PMID: 21727255BACKGROUND

  • 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.

    PMID: 22684990BACKGROUND

  • 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.

    PMID: 17147101BACKGROUND

  • 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.

    PMID: 24999394BACKGROUND

  • Wittek T, Zeiler M, Truttmann S, Philipp J, Kahlenberg L, Schneider A, Kopp K, Krauss H, Auer-Welsbach E, Koubek D, Ohmann S, Werneck-Rohrer S, Sackl-Pammer P, Laczkovics C, Mitterer M, Schmidt U, Karwautz A, Wagner G. The Maudsley model of anorexia nervosa treatment for adolescents and emerging adults: A multi-centre cohort study. Eur Eat Disord Rev. 2025 Nov;33(6):1117-1132. doi: 10.1002/erv.2996. Epub 2023 Jun 11.

    PMID: 37302134DERIVED

  • 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.

    PMID: 33685522DERIVED

MeSH Terms

Conditions

Anorexia NervosaAnorexia

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andreas Karwautz, Univ.-Prof.

    Medical University of Vienna

    STUDY DIRECTOR

  • Gudrun Wagner, Ass.-Prof.

    Medical University of Vienna

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ. Prof. Dr.

Study Record Dates

First Submitted

March 28, 2018

First Posted

May 24, 2018

Study Start

April 25, 2018

Primary Completion

February 28, 2022

Study Completion

August 31, 2022

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations

AU(1)