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Cognitive Therapy for Binge-Eating Disorder

10 de abril de 2013 actualizado por: Cynthia Bulik, PhD, University of North Carolina, Chapel Hill

Cognitive Therapy Via CD-Rom for Binge-Eating Disorder

The purpose of this study is to compare the efficacy of a CD-ROM-based cognitive-behavioral therapy (CBT) to traditional manual-based group therapy for obese individuals with binge-eating disorder (BED) and other unhealthy eating behaviors. A second goal is to encourage a healthy lifestyle in patients with BED.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

Although eating and weight-related disorders are treatable, most afflicted individuals never receive proper treatment.

CD-ROM-based CBT may be an efficacious and cost-effective intervention, a useful adjunct to traditional psychotherapy, or an introductory step to treatment which familiarizes patients with the principles and techniques of CBT and increases their comfort and motivation to seek additional help.

Potential participants undergo a brief telephone screening to ensure their understanding of the study. Individuals who meet preliminary criteria are then scheduled for an initial assessment.

Patients are randomized to 1 of 3 groups. One group is given a copy of the CD-ROM program to complete at home over 10 weeks. At the end of each week, these patients upload and transmit their encrypted tracking data to the research coordinator. At the end of the treatment, participants who have not improved are offered a course of traditional manual-based group therapy, follow-up in an ongoing maintenance group in an eating disorders program, or an alternative treatment.

A second group undergoes standard group CBT. Therapy is administered over 10 weeks in five 90-minute sessions. The key topics are similar to those covered in the CD-ROM group: psychoeducation, developing a personal profile, standardizing meal times, recognizing emotional eating, increasing daily activity, learning the language of CBT, identifying automatic thoughts, restructuring thoughts, identifying cues and consequences, chaining, "surfing the urge," and preventing relapses. Therapy sessions include a didactic section followed by group interaction and discussion. All group sessions are audiotaped and monitored.

Participants in the wait list control group undergo an initial assessment but receive no active intervention for 10 weeks. After 10 weeks, these patients undergo post-treatment assessment and are offered the opportunity to either enter group treatment in an eating disorders program or enter other appropriate treatment. Three-month follow-up data are not collected from these individuals.

Assessments occur at study start, at the end of treatment, and at a 3-month follow-up. Assessments include height and weight measurements and measurements of changes in exercise- and nonexercise-related activity. All participants are given tests and interviews to assess eating disorder symptoms, depression, psychoactive substance abuse and dependence, and functioning. Patients complete self-report questionnaires to assess their cognitive restraint, hunger, disinhibition, strength of urges to binge, and degree of confidence in their ability to resist a binge. Patients also rate the suitability of treatment both prior to and following completion of the intervention.

Tipo de estudio

Intervencionista

Inscripción (Actual)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • University of North Carolina

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 60 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion criteria:

  • Binge-eating disorder (binging an average of once per week for 6 months)
  • Body mass index of 30 or more
  • Regular access to an IBM-compatible computer

Exclusion Criteria:

  • Patients currently taking psychoactive medication will not be excluded provided their unhealthy eating behaviors have remained stable during treatment

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: CD-ROM based CBT
Group is given a copy of the CD-ROM program to complete at home over 10 weeks. At the end of each week, these patients upload and transmit their encrypted tracking data to the research coordinator. At the end of the treatment, participants who have not improved are offered a course of traditional manual-based group therapy, follow-up in an ongoing maintenance group in an eating disorders program, or an alternative treatment.
Otros nombres:
  • Terapia de conducta cognitiva
Comparador activo: Standard Group CBT
Group undergoes standard group CBT. Therapy is administered over 10 weeks in five 90-minute sessions. The key topics are similar to those covered in the CD-ROM group: psychoeducation, developing a personal profile, standardizing meal times, recognizing emotional eating, increasing daily activity, learning the language of CBT, identifying automatic thoughts, restructuring thoughts, identifying cues and consequences, chaining, "surfing the urge," and preventing relapses. Therapy sessions include a didactic section followed by group interaction and discussion. All group sessions are audiotaped and monitored.
Otros nombres:
  • Terapia de conducta cognitiva
Sin intervención: Waiting List
Participants in the wait list control group undergo an initial assessment but receive no active intervention for 10 weeks. After 10 weeks, these patients undergo post-treatment assessment and are offered the opportunity to either enter group treatment in an eating disorders program or enter other appropriate treatment. Three-month follow-up data are not collected from these individuals.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de abril de 2001

Finalización primaria (Actual)

1 de marzo de 2006

Finalización del estudio (Actual)

1 de marzo de 2006

Fechas de registro del estudio

Enviado por primera vez

20 de noviembre de 2002

Primero enviado que cumplió con los criterios de control de calidad

20 de noviembre de 2002

Publicado por primera vez (Estimar)

21 de noviembre de 2002

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

11 de abril de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

10 de abril de 2013

Última verificación

1 de abril de 2013

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • R21MH062053 (Subvención/contrato del NIH de EE. UU.)
  • DSIR AT-AS

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. .

Ensayos clínicos sobre CBT

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