- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05503745
MICBT para adultos sin bajo peso con trastornos alimentarios (MICBT-ED)
TCC-E frente a TCC-F+Terapia interpersonal metacognitiva para adultos sin peso inferior al normal con trastornos alimentarios: protocolo de estudio para un ensayo piloto controlado aleatorizado
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
El estudio es un ensayo controlado aleatorizado piloto que tiene como objetivo evaluar la viabilidad y la eficacia de la MIT semanal en la adicción a la TCC-F en un grupo de adultos diagnosticados con disfunción eréctil. Específicamente, los investigadores investigarán en una muestra de adultos sin peso inferior al normal que presentan disfunción eréctil si, una vez comparado con CBT-E, un tratamiento que combina MIT y CBT-F es a) factible, b) bien tolerado y c) potencialmente efectivo para comer. síntomas de los trastornos y otros resultados.
Los investigadores esperan que el grupo experimental CBT-F+MIT pueda tener una alta adherencia al tratamiento y retención sobre la base de estudios previos de MIT para trastornos de personalidad. También esperarán buenos resultados en el resultado primario. Dada la pequeña muestra, este es solo un estudio piloto, por lo que cualquier conclusión sobre otros resultados se considerará preliminar. Los resultados proporcionarán nueva evidencia que puede llevar a considerar la TCC-F+MIT como una opción de tratamiento para la disfunción eréctil que merece investigaciones en ensayos más amplios.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
VR
-
Verona, VR, Italia, 37100
- Centro di Trattamento Integrato. Disturbi Alimentari e Obesità (CTI) di Gloria Fioravanti
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Descripción
Criterios de inclusión:
- ED diagnosticada en los últimos 6 meses
- Buscando tratamiento para el trastorno alimentario
- Capaz de proporcionar un consentimiento informado por escrito
- IMC > 18,5
Criterio de exclusión:
- episodio psicótico agudo, síntomas psicóticos, trastorno bipolar I; desorden de personalidad antisocial
- Ideación suicida
- Abuso de sustancias
- Intervención psicológica previa para otros trastornos alimentarios
- Actualmente involucrado en otro tratamiento en curso
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: TCC-E
Los participantes en la condición CBT-E recibirán un total de 20 sesiones CBT-E durante 20 semanas.
El tratamiento CBT-E constará de cuatro etapas.
En particular, la TCC tiene como objetivo informar a los pacientes sobre la importancia del autocontrol, los peligros de algunos comportamientos restrictivos como el vómito autoinducido.
Además, la TCC proporciona estrategias a los pacientes para monitorear sus comportamientos generalmente disfuncionales y así aumentar su conciencia (es decir,
método diario de alimentos) al tiempo que reduce la disponibilidad de alimentos y fomenta actividades que son incompatibles con comer en exceso.
Los pacientes serán entrenados en la resolución de problemas para cambiar estos sentimientos, así como en aumentar su autoconciencia para reconocer pensamientos irracionales sobre su peso y forma corporal.
Además, estarán expuestos gradualmente a alimentos que habían estado evitando.
|
En la primera Etapa, el tratamiento se centrará en lograr una comprensión compartida del trastorno alimentario del paciente y los factores de mantenimiento relacionados.
En esta fase se ayudará al paciente a regular y estabilizar sus hábitos alimenticios y así abordar sus problemas de peso.
En la segunda etapa, se revisan en detalle los avances logrados.
En la tercera etapa, las sesiones se centrarán en los procesos centrales que están manteniendo la psicopatología del trastorno alimentario del paciente.
En particular, esto implica abordar las preocupaciones sobre el peso y la forma del cuerpo, la restricción dietética cognitiva y calórica, los eventos y las emociones que afectan la nutrición.
En la fase tres y cuatro también se aborda la perfección clínica, la baja autoestima global, la intolerancia a las emociones y las dificultades interpersonales.
Hacia el final de la tercera etapa y durante la cuarta etapa, también se implementarán procedimientos para minimizar el riesgo de recaída a corto y largo plazo.
|
|
Experimental: TCC-F+MIT
Los participantes en la condición CBT-F+MIT recibirán un total de 20 sesiones durante 20 semanas. Específicamente, 2 sesiones se basarán únicamente en CBT-F como de costumbre. Durante estas sesiones, los participantes recibirán formación psicoeducativa sobre conductas alimentarias y una introducción a las herramientas del protocolo, a saber, el formulario de seguimiento, la tabla de peso, la formulación transdiagnóstica y la Lista de verificación de problemas alimentarios (EPCL). Estos elementos se utilizarán al inicio de las 18 sesiones restantes, con el fin de monitorear la regulación de las conductas alimentarias así como la elicitación de episodios narrativos. Estos materiales formarán la base para la parte MIT de la sesión, en la que los terapeutas buscarán formar con el paciente una comprensión compartida de las razones psicológicas que subyacen a sus síntomas de disfunción eréctil y su funcionamiento interpersonal desadaptativo. Las sesiones de MIT se integrarán dentro del protocolo CBT-F que proporcionará reeducación nutricional y psicoeducativa y manejo para la disfunción eréctil. |
El objetivo es desarrollar estrategias más saludables para manejar los pensamientos y sentimientos negativos que anteceden a la disfunción eréctil y para involucrar a los pacientes en interacciones sociales que satisfagan sus deseos relacionales básicos.
Así comprenderán que el perfeccionismo y la necesidad de control que experimentan a través de la DE son estrategias de afrontamiento desarrolladas dentro de patrones interpersonales de interacción con otras personas significativas, donde la baja autoestima y la desregulación emotiva juegan un papel central.
El MIT tiene como objetivo mejorar la capacidad de los individuos para dar sentido a sus propios afectos y cogniciones y tomar conciencia de que están impulsados por esquemas desadaptativos, rígidos y sesgados sobre sí mismos y los demás, para formar una comprensión más rica de la mente de los demás y utilizar este conocimiento para reaccionar de manera más adaptativa a las dificultades sociales oa los deseos evolutivos seleccionados.
MIT también permite a las personas reflexionar sobre cómo estos esquemas pueden actuar como desencadenantes del comportamiento de ED y desarrollar estrategias de afrontamiento más efectivas frente a los factores estresantes interpersonales.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Eating Disorder Examination Questionnaire (EDE-Q6; Fairburn & Beglin, 1994)
Periodo de tiempo: 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)
|
A self report measure assessing eating disorders over the past 4 weeks, providing a measure of the range of severity of eating disorder features.
|
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)
|
|
Eating Attitude Test (EAT-26; Garner & Garfinkel, 1979)
Periodo de tiempo: 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)
|
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.
|
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)
|
|
Clinical Impairment Assessment Questionnaire (CIA 3.0; Bohn and Fairburn, 2008).
Periodo de tiempo: 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)
|
a self-report measure f assessing the severity of psychosocial impairment due to eating disorder features over the past 28 days.
|
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)
|
|
Binge Eating Scale (BES; Gormally et al., 1992)
Periodo de tiempo: 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)
|
a self-report questionnaire of the behavioral, cognitive and emotional features of objective binge eating (OBE).
|
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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Entrevista clínica estructurada para los trastornos del DSM-5 (SCID-5; Michael B. First, Janet B.W. Williams)
Periodo de tiempo: En la línea de base
|
Para evaluar y definir el Modelo DSM-5 para los Trastornos de la Personalidad.
|
En la línea de base
|
|
State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983)
Periodo de tiempo: 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)
|
A self-report measure of trait and state anxiety.
|
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)
|
|
Beck Depression Inventory (BDI; Beck, et al., 1961)
Periodo de tiempo: 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)
|
A self-report measures of depression.
|
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)
|
|
Symptom Check List (SCL-90)
Periodo de tiempo: 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)
|
A measure of psychopathology symptoms and their intensity at a specific point in time.
|
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)
|
|
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Periodo de tiempo: 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)
|
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.
|
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)
|
|
Toronto Alexithymia Scale (TAS - 20; Taylor & Bagby, 1992)
Periodo de tiempo: 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)
|
It assess difficulties in understanding, processing, or describing emotions
|
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)
|
|
Working Alliance Inventory-Short Revised (WAI; SR Hatcher & Gillaspy, 2006)
Periodo de tiempo: Every 4 weeks during treatment (up to approximately 6 months, until end of treatment).
|
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.
|
Every 4 weeks during treatment (up to approximately 6 months, until end of treatment).
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Gloria Fioravanti, Centro di Trattamento Integrato. Disturbi Alimentari e Obesità (CTI) di Gloria Fioravanti
- Director de estudio: Raffaele Popolo, Centro di Terapia Metacognitiva Interpersonale, Roma
Publicaciones y enlaces útiles
Publicaciones Generales
- 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
- Halmi KA, Goldberg SC, Cunningham S. Perceptual distortion of body image in adolescent girls: distortion of body image in adolescence. Psychol Med. 1977 May;7(2):253-7. doi: 10.1017/s0033291700029330.
- Bruch, H. (1973). Psychiatric aspects of obesity. Psychiatric Annals, 3(7), 6-9.
- Bauer, B. G., & Anderson, W. P. (1989). Bulimic beliefs: Food for thought. Journal of Counseling & Development, 67(7), 416-419.
- Casper, R. C. (1983). On the emergence of bulimia nervosa as a syndrome a historical view. International Journal of Eating Disorders, 2(3), 3-16.
- Davis C. Normal and neurotic perfectionism in eating disorders: an interactive model. Int J Eat Disord. 1997 Dec;22(4):421-6. doi: 10.1002/(sici)1098-108x(199712)22:43.0.co;2-o.
- Bastiani AM, Rao R, Weltzin T, Kaye WH. Perfectionism in anorexia nervosa. Int J Eat Disord. 1995 Mar;17(2):147-52. doi: 10.1002/1098-108x(199503)17:23.0.co;2-x.
- Ruggiero GM, Levi D, Ciuna A, Sassaroli S. Stress situation reveals an association between perfectionism and drive for thinness. Int J Eat Disord. 2003 Sep;34(2):220-6. doi: 10.1002/eat.10191.
- Vitousek, K. B., & Hollon, S. D. (1990). The investigation of schematic content and processing in eating disorders. Cognitive therapy and research, 14(2), 191-214.
- Button EJ, Loan P, Davies J, Sonuga-Barke EJ. Self-esteem, eating problems, and psychological well-being in a cohort of schoolgirls aged 15-16: a questionnaire and interview study. Int J Eat Disord. 1997 Jan;21(1):39-47. doi: 10.1002/(sici)1098-108x(199701)21:13.0.co;2-4.
- 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.
- Neumark-Sztainer D, Hannan PJ. Weight-related behaviors among adolescent girls and boys: results from a national survey. Arch Pediatr Adolesc Med. 2000 Jun;154(6):569-77. doi: 10.1001/archpedi.154.6.569.
- Rastam M. Anorexia nervosa in 51 Swedish adolescents: premorbid problems and comorbidity. J Am Acad Child Adolesc Psychiatry. 1992 Sep;31(5):819-29. doi: 10.1097/00004583-199209000-00007.
- Wichstrom L. Social, psychological and physical correlates of eating problems. A study of the general adolescent population in Norway. Psychol Med. 1995 May;25(3):567-79. doi: 10.1017/s0033291700033481.
- 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.
- Steinberg, S., Tobin, D., & Johnson, C. (1990). The role of bulimic behaviors in affect regulation: Different functions for different patient subgroups?. International Journal of Eating Disorders, 9(1), 51-55.
- Waller, G. (2002). The psychology of binge eating. Eating disorders and obesity: A comprehensive handbook, 2, 98-102.
- Claes L, Vandereycken W, Vertommen H. Self-injurious behaviors in eating-disordered patients. Eat Behav. 2001 Autumn;2(3):263-72. doi: 10.1016/s1471-0153(01)00033-2.
- Holderness CC, Brooks-Gunn J, Warren MP. Co-morbidity of eating disorders and substance abuse review of the literature. Int J Eat Disord. 1994 Jul;16(1):1-34. doi: 10.1002/1098-108x(199407)16:13.0.co;2-t.
- Paul T, Schroeter K, Dahme B, Nutzinger DO. Self-injurious behavior in women with eating disorders. Am J Psychiatry. 2002 Mar;159(3):408-11. doi: 10.1176/appi.ajp.159.3.408.
- 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.
- Steiger H, Gauvin L, Jabalpurwala S, Seguin JR, Stotland S. Hypersensitivity to social interactions in bulimic syndromes: relationship to binge eating. J Consult Clin Psychol. 1999 Oct;67(5):765-75. doi: 10.1037//0022-006x.67.5.765.
- Agras WS, Walsh T, Fairburn CG, Wilson GT, Kraemer HC. A multicenter comparison of cognitive-behavioral therapy and interpersonal psychotherapy for bulimia nervosa. Arch Gen Psychiatry. 2000 May;57(5):459-66. doi: 10.1001/archpsyc.57.5.459.
- Steiger H, Leung F, Thibaudeau J, Houle L, Ghadirian AM. Comorbid features in bulimics before and after therapy: are they explained by axis II diagnoses, secondary effects of bulimia, or both? Compr Psychiatry. 1993 Jan-Feb;34(1):45-53. doi: 10.1016/0010-440x(93)90035-3.
- 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.
- Thompson-Brenner H, Shingleton RM, Thompson DR, Satir DA, Richards LK, Pratt EM, Barlow DH. Focused vs. Broad enhanced cognitive behavioral therapy for bulimia nervosa with comorbid borderline personality: A randomized controlled trial. Int J Eat Disord. 2016 Jan;49(1):36-49. doi: 10.1002/eat.22468. Epub 2015 Dec 9.
- Semerari, A., Carcione, A., Dimaggio, G., Falcone, M., Nicolo, G., Procacci, M., & Alleva, G. (2003). How to evaluate metacognitive functioning in psychotherapy? The metacognition assessment scale and its applications. Clinical Psychology & Psychotherapy, 10(4), 238-261.
- Aloi M, Rania M, Caroleo M, Carbone EA, Fazia G, Calabro G, Segura-Garcia C. How are early maladaptive schemas and DSM-5 personality traits associated with the severity of binge eating? J Clin Psychol. 2020 Mar;76(3):539-548. doi: 10.1002/jclp.22900. Epub 2019 Nov 16.
- Aloi M, Rania M, Carbone EA, Caroleo M, Calabro G, Zaffino P, Nicolo G, Carcione A, Coco GL, Cosentino C, Segura-Garcia C. Metacognition and emotion regulation as treatment targets in binge eating disorder: a network analysis study. J Eat Disord. 2021 Feb 15;9(1):22. doi: 10.1186/s40337-021-00376-x.
- Monteleone, A. M., Corsi, E., Cascino, G., Ruzzi, V., Ricca, V., Ashworth, R., ... & Cardi, V. (2020). The interaction between mentalizing, empathy and symptoms in people with eating disorders: A network analysis integrating experimentally induced and self-report measures. Cognitive Therapy and Research, 44(6), 1140-1149.
- Westwood H, Kerr-Gaffney J, Stahl D, Tchanturia K. Alexithymia in eating disorders: Systematic review and meta-analyses of studies using the Toronto Alexithymia Scale. J Psychosom Res. 2017 Aug;99:66-81. doi: 10.1016/j.jpsychores.2017.06.007. Epub 2017 Jun 11.
- Gilbert, P., & Leahy, R. L. (Eds.). (2009). La relazione terapeutica in terapia cognitivo comportamentale. Eclipsi.
- Boone L, Braet C, Vandereycken W, Claes L. Are maladaptive schema domains and perfectionism related to body image concerns in eating disorder patients? Eur Eat Disord Rev. 2013 Jan;21(1):45-51. doi: 10.1002/erv.2175. Epub 2012 May 3.
- Meneguzzo P, Cazzola C, Castegnaro R, Buscaglia F, Bucci E, Pillan A, Garolla A, Bonello E, Todisco P. Associations Between Trauma, Early Maladaptive Schemas, Personality Traits, and Clinical Severity in Eating Disorder Patients: A Clinical Presentation and Mediation Analysis. Front Psychol. 2021 Mar 31;12:661924. doi: 10.3389/fpsyg.2021.661924. eCollection 2021.
- Dimaggio, G, Semerari, A, Carcione, A, Nicolō, G, & Procacci, M. Psychotherapy of personality disorders: Metacognition, states of mind and interpersonal cycles. 2007; Routledge.
- Dimaggio G, D'Urzo M, Pasinetti M, Salvatore G, Lysaker PH, Catania D, Popolo R. Metacognitive interpersonal therapy for co-occurrent avoidant personality disorder and substance abuse. J Clin Psychol. 2015 Feb;71(2):157-66. doi: 10.1002/jclp.22151. Epub 2014 Dec 31.
- Gordon-King K, Schweitzer RD, Dimaggio G. Metacognitive Interpersonal Therapy for Personality Disorders Featuring Emotional Inhibition: A Multiple Baseline Case Series. J Nerv Ment Dis. 2018 Apr;206(4):263-269. doi: 10.1097/NMD.0000000000000789.
- Inchausti, F., Moreno-Campos, L., Prado-Abril, J., Sánchez-Reales, S., Fonseca-Pedrero, E., MacBeth, A., ... & Dimaggio, G. (2020). Metacognitive Interpersonal Therapy in group for personality disorders: Preliminary results from a pilot study in a public mental health setting. Journal of Contemporary Psychotherapy, 50(3), 197-203.
- Popolo R, MacBeth A, Brunello S, Canfora F, Ozdemir E, Rebecchi D, Toselli C, Venturelli G, Salvatore G, Dimaggio G. Metacognitive interpersonal therapy in group: a feasibility study. Res Psychother. 2018 Dec 18;21(3):338. doi: 10.4081/ripppo.2018.338. eCollection 2018 Dec 19.
- Popolo R, MacBeth A, Canfora F, Rebecchi D, Toselli C, Salvatore G, Dimaggio G. Metacognitive Interpersonal Therapy in group (MIT-G) for young adults with personality disorders: A pilot randomized controlled trial. Psychol Psychother. 2019 Sep;92(3):342-358. doi: 10.1111/papt.12182. Epub 2018 Apr 6.
- Popolo R, MacBeth A, Lazzerini L, Brunello S, Venturelli G, Rebecchi D, Morales MF, Dimaggio G. Metacognitive interpersonal therapy in group versus TAU + waiting list for young adults with personality disorders: Randomized clinical trial. Personal Disord. 2022 Nov;13(6):619-628. doi: 10.1037/per0000497. Epub 2021 Aug 12.
- Fairburn, C. G., & Beglin, S. J. (2008). Eating disorder examination questionnaire. Cognitive behavior therapy and eating disorders, 309, 313.
- Garner, D. M., & Garfinkel, P. A. (1979). Eating attitudes test (EAT-26): Scoring and interpretation. EAT-26 self-test.
- Bohn, K., & Fairburn, C. G. (2008). The clinical impairment assessment questionnaire (CIA). Cognitive behavioral therapy for eating disorders, 315-317.
- Derogatis, L. R., Lipman, R. S., & Covi, L. (1977). SCL-90. Administration, scoring and procedures manual-I for the R (revised) version and other instruments of the Psychopathology Rating Scales Series. Chicago: Johns Hopkins University School of Medicine.
- First, M. B., Williams, J. B., Karg, R. S., & Spitzer, R. L. (2016). User's guide for the SCID-5-CV Structured Clinical Interview for DSM-5® disorders: Clinical version. American Psychiatric Publishing, Inc..
- Taylor GJ, Bagby RM, Parker JD. The Revised Toronto Alexithymia Scale: some reliability, validity, and normative data. Psychother Psychosom. 1992;57(1-2):34-41. doi: 10.1159/000288571.
- Hatcher, R. L., & Gillaspy, J. A. (2006). Development and validation of a revised short version of the Working Alliance Inventory. Psychotherapy research, 16(1), 12-25.
- Semerari A, Colle L, Pellecchia G, Buccione I, Carcione A, Dimaggio G, Nicolo G, Procacci M, Pedone R. Metacognitive dysfunctions in personality disorders: correlations with disorder severity and personality styles. J Pers Disord. 2014 Dec;28(6):751-66. doi: 10.1521/pedi_2014_28_137.
- Grenon R, Carlucci S, Brugnera A, Schwartze D, Hammond N, Ivanova I, Mcquaid N, Proulx G, Tasca GA. Psychotherapy for eating disorders: A meta-analysis of direct comparisons. Psychother Res. 2019 Oct;29(7):833-845. doi: 10.1080/10503307.2018.1489162. Epub 2018 Jun 29.
- Dimaggio, G., Salvatore, G., MacBeth, A., Ottavi, P., Buonocore, L., & Popolo, R. (2017). Metacognitive interpersonal therapy for personality disorders: A case study series. Journal of Contemporary Psychotherapy, 47(1), 11-21.
- Inchausti F, Garcia-Poveda NV, Ballesteros-Prados A, Ortuno-Sierra J, Sanchez-Reales S, Prado-Abril J, Aldaz-Armendariz JA, Mole J, Dimaggio G, Ottavi P, Fonseca-Pedrero E. The Effects of Metacognition-Oriented Social Skills Training on Psychosocial Outcome in Schizophrenia-Spectrum Disorders: A Randomized Controlled Trial. Schizophr Bull. 2018 Oct 17;44(6):1235-1244. doi: 10.1093/schbul/sbx168.
- Inchausti F, Velazquez-Basterra G, Fonseca-Pedrero E, MacBeth A, Popolo R, Dimaggio G. Metacognitive interpersonal group therapy for adolescents with avoidant personality disorder: The case of Sofia. J Clin Psychol. 2022 Aug;78(8):1579-1589. doi: 10.1002/jclp.23356. Epub 2022 Mar 31.
- Cheli S, Cavalletti V, Flett GL, Hewitt PL. Perfectionism unbound: An integrated individual and group intervention for those hiding imperfections. J Clin Psychol. 2022 Aug;78(8):1624-1636. doi: 10.1002/jclp.23365. Epub 2022 Apr 29.
- Anderson DA, Maloney KC. The efficacy of cognitive-behavioral therapy on the core symptoms of bulimia nervosa. Clin Psychol Rev. 2001 Oct;21(7):971-88. doi: 10.1016/s0272-7358(00)00076-3.
- Davis C, Claridge G, Fox J. Not just a pretty face: physical attractiveness and perfectionism in the risk for eating disorders. Int J Eat Disord. 2000 Jan;27(1):67-73. doi: 10.1002/(sici)1098-108x(200001)27:13.0.co;2-f.
- Dimaggio, G., & Lysaker, P. H. (Eds.). (2010). Metacognition and severe adult mental disorders: From research to treatment. Routledge.
- Simonsen S, Popolo R, Juul S, Frandsen FW, Sorensen P, Dimaggio G. Treating Avoidant Personality Disorder With Combined Individual Metacognitive Interpersonal Therapy and Group Mentalization-Based Treatment: A Pilot Study. J Nerv Ment Dis. 2022 Mar 1;210(3):163-171. doi: 10.1097/NMD.0000000000001432.
- McLaren L, Gauvin L, Steiger H. A two-factor model of disordered eating. Eat Behav. 2001 Spring;2(1):51-65. doi: 10.1016/s1471-0153(00)00023-4.
- Stice, E. (1994). Review of the evidence for a sociocultural model of bulimia nervosa and an exploration of the mechanisms of action. Clinical psychology review, 14(7), 633-661.
- Fairburn CG, Peveler RC, Jones R, Hope RA, Doll HA. Predictors of 12-month outcome in bulimia nervosa and the influence of attitudes to shape and weight. J Consult Clin Psychol. 1993 Aug;61(4):696-8. doi: 10.1037//0022-006x.61.4.696.
- Meyer, C., Waller, G., & Waters, A. (1998). Emotional states and bulimic psychopathology. In H. W. Hoek, J. L. Treasure, & M. A. Katzman (Eds.), Neurobiology in the treatment of eating disorders (pp. 271-287). Chichester: Wiley
- Wilson GT, Fairburn CC, Agras WS, Walsh BT, Kraemer H. Cognitive-behavioral therapy for bulimia nervosa: time course and mechanisms of change. J Consult Clin Psychol. 2002 Apr;70(2):267-74.
- Maher A, Cason L, Huckstepp T, Stallman H, Kannis-Dymand L, Millear P, Mason J, Wood A, Allen A. Early maladaptive schemas in eating disorders: A systematic review. Eur Eat Disord Rev. 2022 Jan;30(1):3-22. doi: 10.1002/erv.2866. Epub 2021 Oct 12.
- Basile B, Novello C, Calugi S, Dalle Grave R, Mancini F. Childhood Memories in Eating Disorders: An Explorative Study Using Diagnostic Imagery. Front Psychol. 2021 Jul 22;12:685194. doi: 10.3389/fpsyg.2021.685194. eCollection 2021.
- Misso D, Velotti P, Pasetto A, Dimaggio G. Treating intimate partner violence with metacognitive interpersonal therapy: The case of Aaron. J Clin Psychol. 2022 Jan;78(1):50-66. doi: 10.1002/jclp.23294. Epub 2021 Dec 20.
- Le Grange D, Eckhardt S, Dalle Grave R, Crosby RD, Peterson CB, Keery H, Lesser J, Martell C. Enhanced cognitive-behavior therapy and family-based treatment for adolescents with an eating disorder: a non-randomized effectiveness trial. Psychol Med. 2022 Oct;52(13):2520-2530. doi: 10.1017/S0033291720004407. Epub 2020 Dec 3.
- Wonderlich SA, Peterson CB, Crosby RD, Smith TL, Klein MH, Mitchell JE, Crow SJ. A randomized controlled comparison of integrative cognitive-affective therapy (ICAT) and enhanced cognitive-behavioral therapy (CBT-E) for bulimia nervosa. Psychol Med. 2014 Feb;44(3):543-53. doi: 10.1017/S0033291713001098. Epub 2013 May 23.
- Salvatore G, Buonocore L, Ottavi P, Popolo R, Dimaggio G. Metacognitive Interpersonal Therapy for Treating Persecutory Delusions in Schizophrenia. Am J Psychother. 2018 Dec 1;71(4):164-174. doi: 10.1176/appi.psychotherapy.20180039. Epub 2018 Nov 21.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Desordenes mentales
- Signos y Síntomas Digestivos
- Síntomas de comportamiento
- Trastornos neurocognitivos
- Trastornos cognitivos
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Signos y síntomas
- Comportamiento infantil
- Comportamiento social
- Autocontrol
- Comportamiento problemático
- Disfunción congnitiva
- Desorden de personalidad
- Trastornos de la alimentación y la alimentación
- Regulación Emocional
Otros números de identificación del estudio
- 0000781
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .