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Anorexia NervosaNCT03535714

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

A study testing MANTR-a treatment in people with Anorexia Nervosa and Anorexia, run by Medical University of Vienna at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 14 to 21 years, women only
Conditions the study is for
Anorexia Nervosa, Anorexia
What is being tested?
MANTR-a treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteAustria
Study dates
25 Apr 2018to 31 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 21 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Austria1 site

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

    Vienna, 1090

Other trials in Austria

About this study

Official title: 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).

Read the 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.

Being tested
MANTR-a treatment
Keywords
Treatment, Psychotherapy, Young Adult, Adolescence
Medical subject headings
Anorexia Nervosa, Anorexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MANTR-a treatmentBehavioural

    MANTR-a treatment

Study groups in NCT03535714
Study groupRoleWhat they receive
MANTR-a groupActive comparatorPatients 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.
Receives: Behavioral: MANTR-a treatment
control groupNo interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Increase of BMI

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

    Measured: 12 months

  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

    Measured: 12 months

  3. 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

    Measured: 12 months

Secondary outcomes (18)

  1. Increase of BMI

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

    Measured: 6 months, 18 months

  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

    Measured: 6 months, 18 months

  3. 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

    Measured: 6 months, 18 months

  4. 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)

    Measured: 6 months, 12 months, 18 months

  5. 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)"

    Measured: 6 months, 12 months, 18 months

  6. 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")

    Measured: 6 months, 12 months, 18 months

  7. 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

    Measured: 6 months, 12 months, 18 months

  8. Reduction of anxiety

    "State-Trait-Angstinventar (STAI X1, STAI X2)" is used to assess severity of anxiety from a patients's view

    Measured: 6 months, 12 months, 18 months

  9. Reduction of depression

    "Beck Depressionsinventar (BDI-II)" is used to assess severity of depression from a patients's view

    Measured: 6 months, 12 months, 18 months

  10. Reduction of obsessive-compulsive symptomatology

    "Zwangsinventar (OCI-R)" is used to assess severity of obsessive-compulsive symptomatology from a patients's view

    Measured: 6 months, 12 months, 18 months

  11. Increase of cognitive flexibility

    Cognitive flexibility is measured with "Computergestütztes Kartensortierverfahren (CKV)"

    Measured: 12 months

  12. Increase of central coherence

    Central coherence is measured with "Rey-Osterrieth Complex Figure Test (ROCF)"

    Measured: 12 months

  13. Increase of emotion recognition

    Emotion recognition is measured with "Frankfurter Program to test and to teach the recognition of facial affect (FEFA-2)"

    Measured: 12 months

  14. Influence of motivation of change

    Motivation of change is measured with "Anorexia nervosa Stages of Change Questionnaire (ANSOCQ)"

    Measured: 12 months

  15. Quality of life (group differences, improvement over time)

    Quality of Life is measured with "Lebensqualität von Kindern und Jugendlichen (ILK)"

    Measured: 6 months, 12 months, 18 months

  16. Influence of therapeutic relationship

    Therapeutic relationship is measured with "Fragebogen zur therapeutischen Beziehung für Kinder und Jugendliche (FTB-KJ)"

    Measured: 6 months, 12 months

  17. Influence of treatment contentment

    Treatment contentment is measured with "Fragebogen zur Beurteilung der Behandlung (FBB)"

    Measured: 6 months, 12 months

  18. Changes in personality

    Changes in personality are measured with "Junior Temperament und Charakter Inventar (JTCI 12-18R)"

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2018
  2. Study start25 Apr 2018
  3. Primary completion28 Feb 2022 (estimated)
  4. Study completion31 Aug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03535714
Sponsor's protocol ID
FA765A0306
Status last verified
Mar 2021
First submitted
28 Mar 2018
Last updated
5 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 21727255

  • 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.

    PubMed 22684990

  • 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.

    PubMed 17147101

  • 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.

    PubMed 24999394

  • Kopp K, Truttmann S, Wittek T, Klang J, Krauss H, Aichinger C, Kostner I, Schmidt U, Karwautz A, Zeiler M, Wagner G. Illness severity, treatment motivation and personality as predictors for the treatment outcome in adolescents and young adults with anorexia nervosa. J Eat Disord. 2026 Apr 5;14(1):121. doi: 10.1186/s40337-026-01598-7.

    PubMed 41937155

  • 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.

    PubMed 37302134

  • 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.

    PubMed 33685522

Questions about this trial

What is this clinical trial studying?

A study testing MANTR-a treatment in people with Anorexia Nervosa and Anorexia, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Increase of BMI (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03535714, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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