Dataset Information

The Maudsley model of anorexia nervosa treatment for adolescents and young adults (MANTRa): a study protocol for a multi-center cohort study.

ABSTRACT:

Background

The treatment of anorexia nervosa (AN) is often challenging due to medical complications as well as high relapse and mortality rates. Studies about effective treatment options for people with AN are particularly scarce in the adolescent population. This paper is a study protocol for a multi-center cohort study assessing the feasibility, acceptability and efficacy of a new, manualized treatment program, the "Maudsley Model of Anorexia Nervosa Treatment for Adolescents and Young Adults" (MANTRa) compared to psychotherapeutic treatment as usual (TAU).

Methods/design

One hundred patients between 13 and 21?years who meet the inclusion criteria will receive 24 to 34 individual weekly MANTRa therapy sessions or weekly TAU sessions. Primary outcome variables will be BMI and eating disorder psychopathology 12 months after baseline. Further changes in central coherence, cognitive flexibility, emotion recognition, comorbid psychopathology (e.g. depression, obsessive-compulsive and anxiety disorders, non-suicidal self-injury), personality factors and therapeutic alliance will be assessed.

Discussion

This multi-center study will examine the utility of the treatment program MANTRa for adolescents with AN and, therefore enhances the current knowledge about potential treatments for this patient group.

Trial registration

ClinicalTrials.gov Identifier: NCT03535714 . Registered: 24/05/2018 (retrospectively registered, still recruiting).

SUBMITTER: Wittek T

PROVIDER: S-EPMC7941930 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Publications

The Maudsley model of anorexia nervosa treatment for adolescents and young adults (MANTRa): a study protocol for a multi-center cohort study.

Wittek Tanja T Truttmann Stefanie S Zeiler Michael M Philipp Julia J Auer-Welsbach Ellen E Koubek Doris D Ohmann Susanne S Werneck-Rohrer Sonja S Sackl-Pammer Petra P Schöfbeck Gabriele G Mairhofer Dunja D Kahlenberg Leonie L Schmidt Ulrike U Karwautz Andreas F K AFK Wagner Gudrun G

Journal of eating disorders 20210308 1

<h4>Background</h4>The treatment of anorexia nervosa (AN) is often challenging due to medical complications as well as high relapse and mortality rates. Studies about effective treatment options for people with AN are particularly scarce in the adolescent population. This paper is a study protocol for a multi-center cohort study assessing the feasibility, acceptability and efficacy of a new, manualized treatment program, the "Maudsley Model of Anorexia Nervosa Treatment for Adolescents and Young ...[more]

PMID: 33685522

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Project description:BackgroundThe superiority of Enhanced Cognitive Behavior Therapy (CBT-E) with regard to weight gain and improvement of psychopathology of eating disorders for patients with anorexia nervosa (AN) over other psychotherapies and treatment as usual (TAU) has not been demonstrated in randomized controlled trials (RCTs). However, a previous RCT showed that patients with AN whose baseline body mass index (BMI) was less than 17.5 kg/m2 gained more weight when treated with CBT-E than with other psychotherapies. The aim of the study is to compare the efficacy of CBT-E and TAU for patients with AN. It was hypothesized that CBT-E would be superior to TAU, at least in terms of weight gain, as most patients with AN are likely to have a BMI lower than 17.5 kg/m2.Methods/designA randomized parallel-group multicenter trial will be conducted in three teaching hospitals in Japan between January 2023 and March 2026. Patients with DSM-5 AN, aged 16 years and older, with a BMI equal to or above 14.0 and below 18.5 will be eligible to participate. 56 patients will be randomly and evenly assigned to two intervention groups (CBT-E and TAU). Those assigned to CBT-E will be offered 25-40 sessions in accordance with their initial BMI. Patients assigned to TAU will have at least one session every 2 weeks, with the number of sessions and treatment period not fixed in advance. The primary outcome is BMI at 40 weeks after treatment initiation. The secondary outcomes are the results from the Japanese version of the Eating Disorder Examination Questionnaire and Clinical Impairment Assessment questionnaire to measure eating disorder psychopathology and psychological impairment. The follow-up assessment will be performed 6 months after the 40-week assessment.DiscussionThis multi-center randomized controlled study will probably evaluate the efficacy of CBT-E compared with TAU for patients with more severe AN than in previous studies since Japanese patients are likely to have a lower BMI than those in Western countries. While it may be difficult to generalize the results of a study conducted in Japan, it would be valuable to clarify the efficacy of CBT-E as a treatment package.Trial registrationUMIN, UMIN000048847. Registered 12 Sep 2022.

Project description:Background: Anorexia nervosa (AN) is a serious and life-threatening psychiatric condition. With a paucity of approved treatments, there is a desperate need for novel treatment avenues to be explored. Here, we present (1) an overview of the ways through which Public Patient Involvement (PPI) has informed a trial of psilocybin-assisted therapy for AN and (2) a protocol for a pilot study of psilocybin-assisted therapy in AN currently underway at Imperial College London. The study aims to assess the feasibility, brain mechanisms and preliminary outcomes of treating anorexia nervosa with psilocybin. Methods: (1) PPI: Across two online focus groups, eleven individuals with lived experience of AN were presented with an overview of the protocol. Their feedback not only identified solutions to possible barriers for future participants, but also helped the research team to better understand the concept of "recovery" from the perspective of those with lived experience. (2) Protocol: Twenty female participants [21-65 years old, body mass index (BMI) 15 kg/m2 or above] will receive three oral doses of psilocybin (up to 25 mg) over a 6-week period delivered in a therapeutic environment and enveloped by psychological preparation and integration. We will work with participant support networks (care teams and an identified support person) throughout and there will be an extended remote follow-up period of 12 months. Our two-fold primary outcomes are (1) psychopathology (Eating Disorder Examination) across the 6-month follow-up and (2) readiness and motivation to engage in recovery (Readiness and Motivation Questionnaire) across the 6-week trial period. Neurophysiological outcome measures will be: (1) functional magnetic resonance imaging (fMRI) brain changes from baseline to 6-week endpoint and (2) post-acute changes in electroencephalography (EEG) activity, including an electrophysiological marker of neuronal plasticity. Discussion: The results of this pilot study will not only shed light on the acceptability, brain mechanisms, and impression of the potential efficacy of psilocybin as an adjunct treatment for AN but will be essential in shaping a subsequent Randomised Control Trial (RCT) that would test this treatment against a suitable control condition. Clinical Trial Registration: identifier: NCT04505189.

Project description:BackgroundAnorexia nervosa (AN) is a serious psychiatric illness that begins most of the time during adolescence. An early and efficacious intervention is crucial to minimize the risk of the illness becoming chronic and to limit the occurrence of comorbidities. There is a global consensus on optimal treatment for adolescents suffering from AN: international guidelines recommend single-family therapy that involves the patient and his/her family. Several family therapy approaches have been developed to date. However, these approaches, which imply a direct questioning of intrafamilial dynamics, are not suitable for all patients and families, and the rates of dropout or poor response to treatment remain quite high. A modality of family therapy has been adapted to AN, known as multi-family therapy (MFT), which consists in bringing together several families whose children suffers from the same illness. Objectives of the present randomized clinical trial are to evaluate whether the implementation of MFT in a multi-disciplinary treatment program for adolescents with AN is at least as efficacious as the use of systemic single-family therapy (SFT), with respect to the evolution of body mass index and other clinical outcomes 12 and 18 months after the start of treatment. A cost-efficiency analysis will also be conducted.MethodsOne hundred fifty patients meeting the inclusion criteria will be randomly assigned to one of the two treatment groups. Patients and their families will receive 10 sessions of therapy spread over 12 months. Body weight, eating disorder and other psychopathology-related symptoms, quality of family relationships, and family satisfaction with treatment will be evaluated during the treatment and at an 18 months follow-up. A cost-efficiency analysis will also be carried out.DiscussionWe hypothesize that MFT is at least as efficacious as SFT, but at a lesser cost. The identification of possible preferential indications for each technique could help the improvement of therapeutic indications for adolescents suffering from AN and contribute to the earliness of intervention, which is associated with a better outcome.Trial registrationClinicalTrials.gov, NCT03350594 . Registered on 22 November 2017. IDRCB number 2016-A00818-43.

Dataset Information

The Maudsley model of anorexia nervosa treatment for adolescents and young adults (MANTRa): a study protocol for a multi-center cohort study.

Background

Methods/design

Discussion

Trial registration

Publications

The Maudsley model of anorexia nervosa treatment for adolescents and young adults (MANTRa): a study protocol for a multi-center cohort study.

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