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

Trials (Impact Factor: 1.73). 05/2013; 14(1):160. DOI: 10.1186/1745-6215-14-160
Source: PubMed


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).

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.

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.

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    • "Therapists completed training in both treatment modalities, and patients in either treatment receive 20 to 30 one hour weekly outpatient sessions. Full details of the study protocol of the MOSAIC trial can be found elsewhere (Schmidt et al., 2013). Although RCTs are the 'gold standard' in the evaluation complex interventions, guidelines from the UK Medical Research Council (2008) and a comprehensive systematic review (Greenhalgh, Robert, Macfarlane, Bate, & Kyriakidou, 2004) recognise that combining outcome evaluations with an understanding of therapy process 'can provide useful insights into why an intervention achieves or fails to achieve the expected outcomes'. "
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    ABSTRACT: Forming part of a process evaluation of a large randomised controlled trial (the Maudsley Outpatient Study of Treatments for Anorexia Nervosa and Related conditions, MOSAIC) comparing two outpatient therapies for Anorexia Nervosa (AN), the Maudsley Model for Treatment of Adults with Anorexia Nervosa (MANTRA) and Specialist Supportive Clinical Management (SSCM), this study adopted a qualitative approach to examine therapist experiences of treatment delivery. Twenty MOSAIC therapists completed semi-structured interviews. Interviews were recorded, transcribed and analysed thematically. Themes of positive aspects, challenges and therapeutic fit emerged. MANTRA was seen as structured and flexible but could feel demanding on therapist time and skill. The slow pace and narrower focus of SSCM gave patients space to talk, but the lack of psychological tools and nutritional emphasis could create frustration. Views on the therapeutic relationship and patient-therapy fit differed across treatments. Findings provide testable hypotheses about what works for whom, ideas for therapist training, treatment development and delivery. Copyright © 2014 John Wiley & Sons, Ltd and Eating Disorders Association.
    European Eating Disorders Review 03/2014; 22(2). DOI:10.1002/erv.2278 · 2.46 Impact Factor
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    • "Participants were all treatment-seeking individuals who were assessed at an outpatient ED service and recruited to take part in three clinical trials of outpatient treatments for anorexia and bulimia nervosa, recruiting from catchment area based specialist ED services and with minimal exclusion criteria [31-33]. The data reported here were collected at baseline, as part of a larger assessment battery used prior to randomising participants to a treatment condition. "
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    ABSTRACT: Background This study aimed to assess differences in Quality of Life (QoL) across eating disorder (ED) diagnoses, and to examine the relationship of QoL to specific clinical features. Results 199 patients with a diagnosed ED completed the Clinical Impairment Assessment (CIA) [Cognitive Behavior Therapy and Eating Disorders, 315–318, 2008] and the Eating Disorders Examination (EDE) [Int J Eat Disord 6:1–8]. Differences between diagnostic groups were examined, as were differences between restrictive and binge-purge subtypes. CIA scores and EDE scores were positively correlated and higher in groups with binge-purge behaviours. CIA scores were not correlated with BMI, illness duration or frequency of bingeing/purging behaviours, except in the binge-purge AN group, where CIA scores negatively correlated with BMI. Conclusions Patients with EDs have poor QoL and impairment increases with illness severity. Patients with binge/purge diagnoses are particularly impaired. It remains unclear which clinical features best predict the degree of impairment experienced by patients with EDs.
    International Journal of Eating Disorders 11/2013; 1(1):43. DOI:10.1186/2050-2974-1-43 · 3.13 Impact Factor
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    ABSTRACT: This review summarizes recent evidence on psychological treatments for eating disorders. Eating disorders are serious psychiatric conditions requiring evidence-based intervention. Treatments have been evaluated within each eating disorder diagnosis and across diagnoses. For adults with anorexia nervosa, no one specialist treatment has been shown to be superior. Cognitive behavioral therapy and interpersonal psychotherapy remain the most established treatments for bulimia nervosa and binge eating disorder, with stepped-care approaches showing promise and new behavioral treatments under study. Enhanced cognitive behavioral therapy has improved symptoms in adults and youth. Maudsley family-based therapy is the most established treatment for youth with anorexia nervosa and may be efficacious for youth with bulimia nervosa. Interpersonal psychotherapy for the prevention of excess weight gain may be efficacious for reducing loss of control eating and weight gain in overweight youth. Significant advances in treatments have been made, including evaluation of long-term outcomes, novel approaches, and tailored extension for specific patient profiles. However, widespread access to effective eating disorder treatments remains limited. Increasing the potency and expanding the implementation of psychological treatments beyond research settings into clinical practice has strong potential to increase access to care, thereby reducing the burden of eating disorders.
    Current opinion in psychiatry 09/2013; 26(6). DOI:10.1097/YCO.0b013e328365a30e · 3.94 Impact Factor
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