- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT05503745
MICBT para adultos abaixo do peso com transtornos alimentares (MICBT-ED)
CBT-E vs CBT-F + Terapia Interpessoal Metacognitiva para Adultos Não Abaixo do Peso Com Transtornos Alimentares: Protocolo de Estudo para um Estudo Piloto Randomizado e Controlado
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
O estudo é um ensaio piloto randomizado controlado que visa avaliar a viabilidade e eficácia do MIT semanal em adição ao CBT-F em um grupo de adultos diagnosticados com disfunção erétil. Especificamente, os investigadores investigarão em uma amostra de adultos sem baixo peso apresentando disfunção erétil se, uma vez comparado ao CBT-E, um tratamento combinando MIT e CBT-F é a) viável, b) bem tolerado ec) potencialmente eficaz na alimentação sintomas de distúrbios e outros resultados.
Os investigadores esperam que o grupo experimental CBT-F+MIT seja capaz de ter alta adesão e retenção ao tratamento com base em estudos anteriores de MIT para transtornos de personalidade. Eles também esperam bons resultados no resultado primário. Dada a pequena amostra, este é apenas um estudo piloto, portanto, quaisquer conclusões sobre outros resultados serão consideradas preliminares. Os resultados fornecerão novas evidências que podem levar a considerar o CBT-F+MIT uma opção de tratamento para DE que merece investigações em estudos maiores.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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VR
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Verona, VR, Itália, 37100
- Centro di Trattamento Integrato. Disturbi Alimentari e Obesità (CTI) di Gloria Fioravanti
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Descrição
Critério de inclusão:
- DE diagnosticada nos últimos 6 meses
- Procurando tratamento para transtorno alimentar
- Capaz de fornecer consentimento informado por escrito
- IMC > 18,5
Critério de exclusão:
- Episódio psicótico agudo, sintomas psicóticos, transtorno bipolar I; transtorno de personalidade antisocial
- Ideação suicida
- Abuso de substâncias
- Intervenção psicológica prévia para outros transtornos alimentares
- Atualmente envolvido em outro tratamento em andamento
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: CBT-E
Os participantes na condição CBT-E receberão um total de 20 sessões de CBT-E ao longo de 20 semanas.
O tratamento CBT-E consistirá em quatro etapas.
Em particular, a TCC visa informar os pacientes sobre a importância do autocontrole, os perigos de alguns comportamentos restritivos, como o vômito autoinduzido.
Além disso, a TCC fornece estratégias aos pacientes para monitorar seus comportamentos geralmente disfuncionais e, assim, aumentar sua consciência (ou seja,
método do diário alimentar), reduzindo a disponibilidade de alimentos e incentivando atividades incompatíveis com a alimentação excessiva.
Os pacientes serão treinados na resolução de problemas para mudar esses sentimentos, bem como aumentar sua autoconsciência para reconhecer pensamentos irracionais sobre seu peso e forma corporal.
Além disso, eles serão gradualmente expostos a alimentos que evitavam.
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Na primeira fase, o tratamento será focado em alcançar uma compreensão compartilhada do transtorno alimentar do paciente e dos fatores de manutenção relacionados.
Nesta fase, o paciente será ajudado a regular e estabilizar seus hábitos alimentares e, assim, abordar suas preocupações com o peso.
Na segunda etapa, o progresso alcançado é analisado em detalhes.
Na terceira etapa, as sessões serão focadas nos processos centrais que estão mantendo a psicopatologia do transtorno alimentar do paciente.
Em particular, isso envolve abordar preocupações sobre peso e forma corporal, restrição alimentar cognitiva e calórica, eventos e emoções que afetam a nutrição.
Nas fases três e quatro, também são abordadas a perfeição clínica, a baixa autoestima global, a intolerância às emoções e as dificuldades interpessoais.
No final da terceira fase e durante a quarta fase, também serão implementados procedimentos para minimizar o risco de recaída a curto e longo prazo.
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Experimental: CBT-F+MIT
Os participantes na condição CBT-F+MIT receberão um total de 20 sessões em 20 semanas. Especificamente, 2 sessões serão baseadas apenas no CBT-F como de costume. Durante estas sessões os participantes receberão formação psicoeducativa sobre comportamentos alimentares e uma introdução às ferramentas do protocolo, nomeadamente ficha de monitorização, gráfico de peso, formulação transdiagnóstica e Lista de Verificação de Problemas Alimentares (EPCL). Estes elementos serão utilizados no início das restantes 18 sessões, de forma a monitorizar as regulações dos comportamentos alimentares bem como suscitar episódios narrativos. Esses materiais formarão a base para a parte MIT da sessão, na qual os terapeutas procurarão formar com o paciente uma compreensão compartilhada das razões psicológicas subjacentes aos seus sintomas de TA e seu funcionamento interpessoal desadaptativo. As sessões do MIT serão integradas ao protocolo CBT-F, que fornecerá reeducação psicoeducacional e nutricional e gerenciamento para disfunção erétil. |
O objetivo é desenvolver estratégias mais saudáveis para gerenciar pensamentos e sentimentos negativos antecedentes ao DE e para engajar os pacientes em interações sociais que satisfaçam seus desejos relacionais básicos.
Eles entenderão, assim, que o perfeccionismo e a necessidade de controle que experimentam por meio de DE são estratégias de enfrentamento desenvolvidas em padrões interpessoais de interação com outras pessoas significativas, onde a baixa autoestima e a desregulação emotiva desempenham um papel central.
O MIT visa melhorar a capacidade dos indivíduos de entender seus próprios afetos e cognições e tornar-se consciente de ser impulsionado por esquemas desadaptativos, rígidos e tendenciosos sobre si mesmo e os outros, para formar uma compreensão mais rica da mente dos outros e usar esse conhecimento para reagem de forma mais adaptativa às dificuldades sociais ou aos desejos evolutivos selecionados.
O MIT também permite que os indivíduos reflitam sobre como esses esquemas podem atuar como gatilhos para o comportamento de DE e desenvolvam estratégias de enfrentamento mais eficazes diante de estressores interpessoais.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Eating Disorder Examination Questionnaire (EDE-Q6; Fairburn & Beglin, 1994)
Prazo: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)
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A self report measure assessing eating disorders over the past 4 weeks, providing a measure of the range of severity of eating disorder features.
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Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)
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Eating Attitude Test (EAT-26; Garner & Garfinkel, 1979)
Prazo: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)
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A self-report measure for identifying the presence of "eating disorder risk" based on attitudes, feelings and behaviors related to eating.
It assesses general eating behaviour and risky behaviours.
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Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)
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Clinical Impairment Assessment Questionnaire (CIA 3.0; Bohn and Fairburn, 2008).
Prazo: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)
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a self-report measure f assessing the severity of psychosocial impairment due to eating disorder features over the past 28 days.
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Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)
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Binge Eating Scale (BES; Gormally et al., 1992)
Prazo: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)
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a self-report questionnaire of the behavioral, cognitive and emotional features of objective binge eating (OBE).
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Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Entrevista clínica estruturada para transtornos do DSM-5 (SCID-5; Michael B. First, Janet B.W. Williams)
Prazo: Na linha de base
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Para avaliar e definir o Modelo DSM-5 para Transtornos da Personalidade.
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Na linha de base
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State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983)
Prazo: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)
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A self-report measure of trait and state anxiety.
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Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)
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Beck Depression Inventory (BDI; Beck, et al., 1961)
Prazo: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)
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A self-report measures of depression.
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Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)
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Symptom Check List (SCL-90)
Prazo: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)
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A measure of psychopathology symptoms and their intensity at a specific point in time.
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Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)
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Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Prazo: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)
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A self-report scale measuring individual differences in the ability to identify, accept and manage emotional experiences.
This measure help in understanding emotional dysregulation that might underlie the disorders.
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Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)
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Toronto Alexithymia Scale (TAS - 20; Taylor & Bagby, 1992)
Prazo: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)
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It assess difficulties in understanding, processing, or describing emotions
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Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)
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Working Alliance Inventory-Short Revised (WAI; SR Hatcher & Gillaspy, 2006)
Prazo: Every 4 weeks during treatment (up to approximately 6 months, until end of treatment).
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It measure the therapeutic alliance by assessing three main aspects of the therapeutic alliance: agreement on the tasks of therapy, agreement on the goals of therapy and development of an affective bond.
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Every 4 weeks during treatment (up to approximately 6 months, until end of treatment).
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Gloria Fioravanti, Centro di Trattamento Integrato. Disturbi Alimentari e Obesità (CTI) di Gloria Fioravanti
- Diretor de estudo: Raffaele Popolo, Centro di Terapia Metacognitiva Interpersonale, Roma
Publicações e links úteis
Publicações Gerais
- Fairburn CG, Cooper Z, Doll HA, O'Connor ME, Palmer RL, Dalle Grave R. Enhanced cognitive behaviour therapy for adults with anorexia nervosa: a UK-Italy study. Behav Res Ther. 2013 Jan;51(1):R2-8. doi: 10.1016/j.brat.2012.09.010. Epub 2012 Oct 22.
- Fairburn CG, Cooper Z, Doll HA, O'Connor ME, Bohn K, Hawker DM, Wales JA, Palmer RL. Transdiagnostic cognitive-behavioral therapy for patients with eating disorders: a two-site trial with 60-week follow-up. Am J Psychiatry. 2009 Mar;166(3):311-9. doi: 10.1176/appi.ajp.2008.08040608. Epub 2008 Dec 15.
- BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
- Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
- Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
- Gormally J, Black S, Daston S, Rardin D. The assessment of binge eating severity among obese persons. Addict Behav. 1982;7(1):47-55. doi: 10.1016/0306-4603(82)90024-7.
- Murphy R, Straebler S, Cooper Z, Fairburn CG. Cognitive behavioral therapy for eating disorders. Psychiatr Clin North Am. 2010 Sep;33(3):611-27. doi: 10.1016/j.psc.2010.04.004.
- Fairburn CG, Bailey-Straebler S, Basden S, Doll HA, Jones R, Murphy R, O'Connor ME, Cooper Z. A transdiagnostic comparison of enhanced cognitive behaviour therapy (CBT-E) and interpersonal psychotherapy in the treatment of eating disorders. Behav Res Ther. 2015 Jul;70:64-71. doi: 10.1016/j.brat.2015.04.010. Epub 2015 Apr 22.
- Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of psychopathology and behavioral assessment, 26(1), 41-54.
- Dalle Grave R, Calugi S, Conti M, Doll H, Fairburn CG. Inpatient cognitive behaviour therapy for anorexia nervosa: a randomized controlled trial. Psychother Psychosom. 2013;82(6):390-8. doi: 10.1159/000350058. Epub 2013 Sep 20.
- Fairburn CG, Cooper Z, Shafran R. Cognitive behaviour therapy for eating disorders: a "transdiagnostic" theory and treatment. Behav Res Ther. 2003 May;41(5):509-28. doi: 10.1016/s0005-7967(02)00088-8.
- Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., & Jacobs, G. A. (1983). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.
- Fairburn CG, Patel V. The global dissemination of psychological treatments: a road map for research and practice. Am J Psychiatry. 2014 May;171(5):495-8. doi: 10.1176/appi.ajp.2013.13111546. No abstract available.
- Poulsen S, Lunn S, Daniel SI, Folke S, Mathiesen BB, Katznelson H, Fairburn CG. A randomized controlled trial of psychoanalytic psychotherapy or cognitive-behavioral therapy for bulimia nervosa. Am J Psychiatry. 2014 Jan;171(1):109-16. doi: 10.1176/appi.ajp.2013.12121511.
- Dalle Grave R, Calugi S, Doll HA, Fairburn CG. Enhanced cognitive behaviour therapy for adolescents with anorexia nervosa: an alternative to family therapy? Behav Res Ther. 2013 Jan;51(1):R9-R12. doi: 10.1016/j.brat.2012.09.008. Epub 2012 Oct 4.
- Dalle Grave R, Calugi S, El Ghoch M, Conti M, Fairburn CG. Inpatient cognitive behavior therapy for adolescents with anorexia nervosa: immediate and longer-term effects. Front Psychiatry. 2014 Feb 12;5:14. doi: 10.3389/fpsyt.2014.00014. eCollection 2014.
- Fairburn CG, Norman PA, Welch SL, O'Connor ME, Doll HA, Peveler RC. A prospective study of outcome in bulimia nervosa and the long-term effects of three psychological treatments. Arch Gen Psychiatry. 1995 Apr;52(4):304-12. doi: 10.1001/archpsyc.1995.03950160054010.
- Fairburn, CG. Interpersonal psychotherapy for bulimia nervosa. 1997
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- Button EJ, Sonuga-Barke EJ, Davies J, Thompson M. A prospective study of self-esteem in the prediction of eating problems in adolescent schoolgirls: questionnaire findings. Br J Clin Psychol. 1996 May;35(2):193-203. doi: 10.1111/j.2044-8260.1996.tb01176.x.
- Canals J, Carbajo G, Fernandez J, Marti-Henneberg C, Domenech E. Biopsychopathologic risk profile of adolescents with eating disorder symptoms. Adolescence. 1996 Summer;31(122):443-50.
- Geller J, Srikameswaran S, Cockell SJ, Zaitsoff SL. Assessment of shape- and weight-based self-esteem in adolescents. Int J Eat Disord. 2000 Nov;28(3):339-45. doi: 10.1002/1098-108x(200011)28:33.0.co;2-r.
- Ghaderi A, Scott B. Prevalence, incidence and prospective risk factors for eating disorders. Acta Psychiatr Scand. 2001 Aug;104(2):122-30. doi: 10.1034/j.1600-0447.2001.00298.x.
- Lilenfeld LR, Kaye WH, Greeno CG, Merikangas KR, Plotnicov K, Pollice C, Rao R, Strober M, Bulik CM, Nagy L. A controlled family study of anorexia nervosa and bulimia nervosa: psychiatric disorders in first-degree relatives and effects of proband comorbidity. Arch Gen Psychiatry. 1998 Jul;55(7):603-10. doi: 10.1001/archpsyc.55.7.603.
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- Fairburn CG, Welch SL, Doll HA, Davies BA, O'Connor ME. Risk factors for bulimia nervosa. A community-based case-control study. Arch Gen Psychiatry. 1997 Jun;54(6):509-17. doi: 10.1001/archpsyc.1997.01830180015003.
- Fairburn CG, Doll HA, Welch SL, Hay PJ, Davies BA, O'Connor ME. Risk factors for binge eating disorder: a community-based, case-control study. Arch Gen Psychiatry. 1998 May;55(5):425-32. doi: 10.1001/archpsyc.55.5.425.
- Fairburn CG, Cooper Z, Doll HA, Welch SL. Risk factors for anorexia nervosa: three integrated case-control comparisons. Arch Gen Psychiatry. 1999 May;56(5):468-76. doi: 10.1001/archpsyc.56.5.468.
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- Fairburn CG, Shafran R, Cooper Z. A cognitive behavioural theory of anorexia nervosa. Behav Res Ther. 1999 Jan;37(1):1-13. doi: 10.1016/s0005-7967(98)00102-8.
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- Fairburn, C. G. (2008). Cognitive behavior therapy and eating disorders. Guilford Press.
- Cooper Z, Fairburn CG. The Evolution of "Enhanced" Cognitive Behavior Therapy for Eating Disorders: Learning From Treatment Nonresponse. Cogn Behav Pract. 2011 Aug;18(3):394-402. doi: 10.1016/j.cbpra.2010.07.007.
- Zipfel S, Wild B, Gross G, Friederich HC, Teufel M, Schellberg D, Giel KE, de Zwaan M, Dinkel A, Herpertz S, Burgmer M, Lowe B, Tagay S, von Wietersheim J, Zeeck A, Schade-Brittinger C, Schauenburg H, Herzog W; ANTOP study group. Focal psychodynamic therapy, cognitive behaviour therapy, and optimised treatment as usual in outpatients with anorexia nervosa (ANTOP study): randomised controlled trial. Lancet. 2014 Jan 11;383(9912):127-37. doi: 10.1016/S0140-6736(13)61746-8. Epub 2013 Oct 14.
- Frostad S, Danielsen YS, Rekkedal GA, Jevne C, Dalle Grave R, Ro O, Kessler U. Implementation of enhanced cognitive behaviour therapy (CBT-E) for adults with anorexia nervosa in an outpatient eating-disorder unit at a public hospital. J Eat Disord. 2018 May 29;6:12. doi: 10.1186/s40337-018-0198-y. eCollection 2018.
- Frostad S, Calugi S, Engen CBN, Dalle Grave R. Enhanced cognitive behaviour therapy (CBT-E) for severe and extreme anorexia nervosa in an outpatient eating disorder unit at a public hospital: a quality-assessment study. J Eat Disord. 2021 Nov 2;9(1):143. doi: 10.1186/s40337-021-00499-1.
- Linardon J, Hindle A, Brennan L. Dropout from cognitive-behavioral therapy for eating disorders: A meta-analysis of randomized, controlled trials. Int J Eat Disord. 2018 May;51(5):381-391. doi: 10.1002/eat.22850. Epub 2018 Mar 1.
- Allen KL, Fursland A, Raykos B, Steele A, Watson H, Byrne SM. Motivation-focused treatment for eating disorders: a sequential trial of enhanced cognitive behaviour therapy with and without preceding motivation-focused therapy. Eur Eat Disord Rev. 2012 May;20(3):232-9. doi: 10.1002/erv.1131. Epub 2011 Jul 26.
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Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Sinais e Sintomas Digestivos
- Sintomas Comportamentais
- Distúrbios Neurocognitivos
- Distúrbios Cognitivos
- Condições Patológicas, Sinais e Sintomas
- Comportamento
- Sinais e sintomas
- Comportamento infantil
- Comportamento social
- Auto-controle
- Comportamento problemático
- Disfunção cognitiva
- Transtornos de Personalidade
- Alimentação e Distúrbios Alimentares
- Regulação Emocional
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- 0000781
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- SEIVA
- ANALYTIC_CODE
- CSR
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