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

Sabine Landau⁷  Janet Treasure⁴  Jennifer Beecham³  Linette Whitehead⁶  Nicky Boughton⁶  Eric Johnson-Sabine¹  Lorna Richards¹  Lucy Serpell²  Shreena Ghelani⁵  Charlotte Watson⁵  Rachel Loomes⁶  Hannah Broadbent⁴  Hannah DeJong⁴  Martha Kenyon⁴  Anna Lose⁴  Beth Renwick⁴  Ulrike Schmidt⁴ 

[1] The Phoenix Wing, St Ann’s Hospital, Tottenham, London, UK;Research Department of Clinical, Educational & Health Psychology, University College London, London, UK;Personal Social Services Research Unit, University of Kent, Canterbury, UK;PO59, Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, King’s College London, De Crespigny Park, London SE5 8AF, UK;MHRN North London Hub, 20 Eastbourne Terrace, London, UK;Oxford Adult Eating Disorder Service, Cotswold House, Warneford Hospital, Oxford, UK;Department of Biostatistics, Institute of Psychiatry, Kings College London, London, UK

关键词: Cost effectiveness;    Randomized controlled trial;    Outpatient treatment;    Eating disorder not otherwise specified;    Anorexia nervosa;   

Others  :  1093799
DOI  :  10.1186/1745-6215-14-160

 received in 2012-12-18, accepted in 2013-05-14,  发布年份 2013

【 摘 要 】

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.

【 授权许可】

   
2013 Schmidt et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Treasure J, Claudino A, Zucker N: Eating disorders. Lancet 2010, 375:583-593.
• [2]Lopez C, Tchanturia K, Stahl D, Treasure J: Weak central coherence in eating disorders: a step towards looking for an endophenotype of eating disorders. J Clin Exp Neuropsychol 2009, 31:117-125.
• [3]Oldershaw A, Hambrook D, Stahl D, Tchanturia K, Treasure J, Schmidt U: The socio-emotional processing stream in anorexia nervosa. Neurosci Biobehav Rev 2011, 35:970-988.
• [4]Roberts ME, Tchanturia K, Stahl D, Southgate L, Treasure J: A systematic review and meta-analysis of set-shifting ability in eating disorders. Psychol Med 2007, 37:1075-1084.
• [5]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, 45:343-366.
• [6]Vos T, Mathers C, Herrman H, Harvey C, Gureje O, Bui D, Watson N, Begg S: The burden of mental disorders in Victoria, 1996. Soc Psychiatry Psychiatr Epidemiol 2001, 36:53-62.
• [7]Crow SJ, Nyman JA: The cost-effectiveness of anorexia nervosa treatment. Int J Eat Disord 2004, 35:155-160.
• [8]Striegel-Moore RH, Leslie D, Petrill SA, Garvin V, Rosenheck RA: One-year use and cost of inpatient and outpatient services among female and male patients with an eating disorder: evidence from a national database of health insurance claims. Int J Eat Disord 2000, 27:381-389.
• [9]Thompson A, Shaw M, Harrison G, Ho D, Gunnell D, Verne J: Patterns of hospital admission for adult psychiatric illness in England: analysis of Hospital Episode Statistics data. Br J Psychiatry 2004, 185:334-341.
• [10]Byford S, Barrett B, Roberts C, Clark A, Edwards V, Smethurst N, Gowers SG: Economic evaluation of a randomized controlled trial for anorexia nervosa in adolescents. Br J Psychiatry 2007, 191:436-440.
• [11]Treasure J, Murphy T, Szmukler G, Todd G, Gavan K, Joyce J: The experience of caregiving for severe mental illness: a comparison between anorexia nervosa and psychosis. Soc Psychiatry Psychiatr Epidemiol 2001, 36:343-347.
• [12]Simon J, Schmidt U, Pilling S: The health service use and cost of eating disorders. Psychol Med 2005, 35:1543-1551.
• [13]Costs of eating disorders in England: economic impact of anorexia nervosa, bulimia nervosa and other disorders focusing on young people. [http://www.b-eat.co.uk/about-beat/media-centre/press-releases/staggering-cost-of-eating-disorders webcite]
• [14]le Grange D, Eisler I: Family interventions in adolescent anorexia nervosa. Child Adolesc Psychiatr Clin N Am 2009, 18:159-173.
• [15]DeJong H, Broadbent H, Schmidt U: A systematic review of drop-out from treatment in outpatients with anorexia nervosa. Int J Eat Disord 2012, 45:635-647.
• [16]Berkman ND, Lohr KN, Bulik CM: Outcomes of eating disorders: a systematic review of the literature. Int J Eat Disord 2007, 40:293-309.
• [17]National Collaborating Centre for Mental Health: Eating Disorders: Core interventions in the treatment and management of anorexia nervosa, bulimia nervosa and related eating disorders. UK: British Psychological Society; 2004.
• [18]McIntosh VV, Jordan J, Carter FA, Luty SE, McKenzie JM, Bulik CM, Frampton CM, Joyce PR: Three psychotherapies for anorexia nervosa: a randomized, controlled trial. Am J Psychiatry 2005, 162:741-747.
• [19]Schmidt U, Oldershaw A, Jichi F, Sternheim L, Startup H, McIntosh V, Jordan J, Tchanturia K, Wolff G, Rooney M: Out-patient psychological therapies for adults with anorexia nervosa: randomized controlled trial. Br J Psychiatry 2012, 201:392-399.
• [20]Wade TD, Treasure J, Schmidt U: A case series evaluation of the Maudsley Model for treatment of adults with anorexia nervosa. Eur Eat Disord Rev 2011, 19:382-389.
• [21]Serpell L, Treasure J, Teasdale J, Sullivan V: Anorexia nervosa: friend or foe? Int J Eat Disord 1999, 25:177-186.
• [22]Serpell L, Neiderman M, Haworth E, Emmanueli F, Lask B: The use of the Pros and Cons of Anorexia Nervosa (P-CAN) scale with children and adolescents. J Psychosom Res 2003, 54:567-571.
• [23]Serpell L, Teasdale JD, Troop NA, Treasure J: The development of the P-CAN, a measure to operationalize the pros and cons of anorexia nervosa. Int J Eat Disord 2004, 36:416-433.
• [24]Miller WR, Rollnick S: Motivational Interviewing. Preparing People for Change. 2nd edition. New York: Guilford Press; 2002.
• [25]National Institute for Health and Clinical Excellence: Behaviour change at population, community and individual levels. Leicester & London, UK: British Psychological Society and Gaskell; 2007.
• [26]Abraham C, Michie S: A taxonomy of behavior change techniques used in interventions. Health Psychol 2008, 27:379-387.
• [27]McIntosh VV, Jordan J, McKenzie JM, Luty SE, Carter FA, Carter JD, Frampton CM, Joyce PR: Measuring therapist adherence in psychotherapy for anorexia nervosa: scale adaptation, psychometric properties, and distinguishing psychotherapies. Psychother Res 2005, 15:339-344.
• [28]McIntosh VV, Jordan J, Luty SE, Carter FA, McKenzie JM, Bulik CM, Joyce PR: Specialist supportive clinical management for anorexia nervosa. Int J Eat Disord 2006, 39:625-632.
• [29]Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S: Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol 2004, 23:443-451.
• [30]Moyers TB, Martin T, Catley D, Harris KJ, Ahluwalia JS: Assessing the integrity of motivational interviewing interventions: Reliability of the motivational interviewing skills code. Behav Cogn Psychother 2003, 31:177-184.
• [31]Moyers TB, Martin T, Manuel JK, Hendrickson SM, Miller WR: Assessing competence in the use of motivational interviewing. J Subst Abuse Treat 2005, 28:19-26.
• [32]Thomas JJ, Vartanian LR, Brownell KD: The relationship between eating disorder not otherwise specified (EDNOS) and officially recognized eating disorders: meta-analysis and implications for DSM. Psychol Bull 2009, 135:407-433.
• [33]Wild B, Friederich HC, Gross G, Teufel M, Herzog W, Giel KE, de Zwaan M, Schauenburg H, Schade-Brittinger C, Schafer H, Zipfel S: The ANTOP study: focal psychodynamic psychotherapy, cognitive-behavioral therapy, and treatment-as-usual in outpatients with anorexia nervosa–a randomized controlled trial. Trials 2009, 10:23. BioMed Central Full Text
• [34]Fairburn C, Cooper Z, O’Connor M: Eating disorder examination (edition 16.0D). In Cognitive behavior therapy and eating disorders. Edited by Fairburn C. New York: Guilford Press; 2008.
• [35]Fairburn CG, Beglin SJ: Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord 1994, 16:363-370.
• [36]Lovibond SH, Lovibond PF: Manual for the Depression Anxiety Stress Scales. 2nd edition. Sydney,Australia: Psychology Foundation; 1995.
• [37]Foa EB, Kozak MJ, Salkovskis PM, Coles ME, Amir N: The validation of a new obsessive-compulsive disorder scale: the obsessive-compulsive inventory. Psychol Assess 1998, 10:206-214.
• [38]Martin MM, Rubin RB: A new measure of cognitive flexibility. Psychol Rep 1995, 76:623-626.
• [39]Rimes KA, Chalder T: The Beliefs about Emotions Scale: validity, reliability and sensitivity to change. J Psychosom Res 2010, 68:285-292.
• [40]Gross JJ, John OP: Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol 2003, 85:348-362.
• [41]Grant DA, Berg EA: A behavioral analysis of degree of reinforcement and ease of shifting to new responses in a Weigl-type card-sorting problem. J Exp Psychol 1948, 38:404-411.
• [42]Psychological Assessment Resources: Computerized Wisconsin Card Sort Task Version 4 (WCST). Odessa, Florida, USA: Psychological Assessment Resources; 2003.
• [43]Burgess P, Shallice T: The Hayling and Brixton Tests. Bury St. Edmunds, UK: Thames Valley Test Company; 1997.
• [44]Osterrieth PA: Le test de copied’une figure complexe. Arch Psychol 1944, 30:206-356.
• [45]Rey A: L’examen psychologique dans les cas d’encephalopathie traumatique. Arch Psychol 1941, 28:215-285.
• [46]Golan O, Baron-Cohen S, Hill JJ, Golan Y: The ‘Reading the Mind in Films’ Task: complex emotion recognition in adults with and without autism spectrum conditions. Soc Neurosci 2006, 1:111-123.
• [47]Beecham J, Knapp M: Costing psychiatric interventions. In Measuring mental health needs. Edited by Thornicroft G. London, UK: Gaskell; 2001:200-224.
• [48]Bohn K, Fairburn CG: The Clinical Impairment Assessment questionnaire (CIA). In Cognitive Behavioral Therapy for Eating Disorders. Edited by Fairburn CG. New York: Guildford Press; 2008.
• [49]Rabe-Hesketh S, Skrondal A: Multilevel and Longitudinal Modeling Using Stata. 2nd edition. USA: Stata Press; 2008.
• [50]Carter FA, Jordan J, McIntosh VV, Luty SE, McKenzie JM, Frampton CM, Bulik CM, Joyce PR: The long-term efficacy of three psychotherapies for anorexia nervosa: a randomized, controlled trial. Int J Eat Disord 2011, 44:647-654.
• [51]Dunn G, Maracy M, Dowrick C, Ayuso-Mateos JL, Dalgard OS, Page H, Lehtinen V, Casey P, Wilkinson C, Vázquez-Barquero JL: Estimating psychological treatment effects from a randomized controlled trial with both non-compliance and loss to follow-up. Br J Psychiatry 2003, 183:323-331.
• [52]Baron RM, Kenny DA: The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol 1986, 51:1173-1182.
• [53]StataCorp: Stata Statistical Software: Release 12. College Station, TX: StataCorp LP; 2011.
• [54]Curtis L: Unit Costs of Health and Social Care. Canterbury: University of Kent; 2008.
• [55]Boutron I, Moher D, Altman D, Schulz K, Ravaud P, for the CONSORT group: Methods and Processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments. Ann Intern Med 2008, 148:W60-W67.
• [56]Boutron I, Moher D, Altman D, Schulz K, Ravaud P, for the CONSORT group: Extending the CONSORT Statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008, 148:295-309.