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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-25

Study Completion Date

2022-08-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Anorexia Nervosa Anorexia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

MANTR-a treatment

Intervention Type BEHAVIORAL

MANTR-a treatment

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MANTR-a treatment

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Maximum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No