The MOSAIC study - comparison of the Maudsley Model of Treatment for Adults with Anorexia Nervosa (MANTRA) with Specialist Supportive Clinical Management (SSCM) in outpatients with anorexia nervosa or eating disorder not otherwise specified,anorexia nervosa type: study protocol for a randomized controlled trial

Background: Anorexia nervosa (AN) is a biologically based serious mental disorder with high levels of mortality

and disability, physical and psychological morbidity and impaired quality of life. AN is one of the leading causes of

disease burden in terms of years of life lost through death or disability in young women. Psychotherapeutic

interventions are the treatment of choice for AN, but the results of psychotherapy depend critically on the stage of

the illness. The treatment response in adults with a chronic form of the illness is poor and drop-out from treatment

is high. Despite the seriousness of the disorder the evidence-base for psychological treatment of adults with AN is

extremely limited and there is no leading treatment. There is therefore an urgent need to develop more effective

treatments for adults with AN. The aim of the Maudsley Outpatient Study of Treatments for Anorexia Nervosa and

Related Conditions (MOSAIC) is to evaluate the efficacy and cost effectiveness of two outpatient treatments for

adults with AN, Specialist Supportive Clinical Management (SSCM) and the Maudsley Model of Treatment for Adults

with Anorexia Nervosa (MANTRA).

Methods/Design: 138 patients meeting the inclusion criteria are randomly assigned to one of the two treatment

groups (MANTRA or SSCM). All participants receive 20 once-weekly individual therapy sessions (with 10 extra weekly

sessions for those who are severely ill) and four follow-up sessions with monthly spacing thereafter. There is also

optional access to a dietician and extra sessions involving a family member or a close other. Body weight, eating

disorder- related symptoms, neurocognitive and psychosocial measures, and service use data are measured during

the course of treatment and across a one year follow up period. The primary outcome measure is body mass index

(BMI) taken at twelve months after randomization.

Discussion: This multi-center study provides a large sample size, broad inclusion criteria and a follow-up period.

However, the study has to contend with difficulties directly related to running a large multi-center randomized

controlled trial and the psychopathology of AN. These issues are discussed.

Trial Registration: Current Controlled Trials ISRCTN67720902 - A Maudsley outpatient study of treatments for

anorexia nervosa and related conditions.