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Imagery-based CBT for Social Anxiety Disorder: Piloting a Treatment Augmentation Protocol

28 de diciembre de 2016 actualizado por: Karen Rowa, St. Joseph's Healthcare Hamilton
The purpose of this pilot study is to explore whether there is a differential impact of verbal versus imagery-based cognitive behavioural therapy (CBT) as a treatment augmentation strategy for individuals with social anxiety disorder (SAD). Clients who have not demonstrated clinically significant change following group CBT for SAD will receive four additional sessions of either verbal-based CBT or imagery-based CBT. We hypothesize that that individuals who receive imagery-based CBT will experience even stronger improvements and be more satisfied with their treatment than individuals who received traditional verbal-linguistic CBT.

Descripción general del estudio

Estado

Terminado

Descripción detallada

Social Anxiety Disorder (SAD) is a debilitating disorder, marked by significant functional impairment and high personal distress for those who suffer. Psychological treatment for SAD has traditionally been verbal-linguistic cognitive behavioural therapy (CBT). However, a significant number of individuals who complete CBT for SAD do not achieve full response and continue to struggle with significant residual symptoms. One innovation that has received attention recently in the literature is using imagery-based CBT as a way to augment treatment outcome in SAD. Results from a pilot and benchmarking study suggest that participants who received imagery-based CBT were more likely to complete treatment than those who received traditional CBT and treatment outcome was strong for both groups, but stronger in the imagery-based CBT group.

However, before re-training hundreds of practitioners in using a completely novel treatment approach, it is important to see if a brief augmentation of traditional CBT programs is effective in producing further change for individuals with residual symptoms after group CBT. It is possible that individuals just require a few more sessions of the same verbal-linguistic CBT to consolidate treatment gains or work on lingering triggers of anxiety. It is also possible that more of the same is not as valuable as offering therapy using a different modality, such as imagery. Therefore, we propose to evaluate a brief imagery-based augmentation of traditional group CBT to explore its effects on further symptom reduction.

Tipo de estudio

Intervencionista

Inscripción (Actual)

9

Fase

  • No aplica

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 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Completed eight out of twelve sessions of standard verbal-linguistic group cognitive behavioural therapy for social anxiety disorder
  • Presented with a Social Phobia Inventory (SPIN) score of greater than 19 post-treatment
  • Interested in further treatment

Exclusion Criteria:

  • Has another mental health concern of greater importance than social anxiety disorder

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
Comparador activo: Verbal-linguistic CBT
Participants will receive 4 sessions of verbal cognitive restructuring and exposure therapy delivered in an individual therapy format.
Participants will receive 4 sessions of individual therapy focused on traditional cognitive restructuring and exposure therapy.
Experimental: Imagery-based CBT
Participants will receive 4 sessions of imagery-based cognitive work and behavioural experiments delivered in an individual therapy format.
Participants will receive 4 sessions of individual therapy focused on imagery-based cognitive work and behavioural experiments.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Social Phobia Inventory
Periodo de tiempo: This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Measures social anxiety symptoms
This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Vividness of Visual Imagery Questionnaire
Periodo de tiempo: This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Measures the ability to visualize several visual images
This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Homework Adherence Scale
Periodo de tiempo: This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Measures the quality of homework completion
This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Treatment Satisfaction Scale
Periodo de tiempo: This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Measures the participant's satisfaction with their treatment
This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Brief Fear of Negative Evaluation Scale
Periodo de tiempo: This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Measures fears about being negatively evaluated by others
This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Illness Intrusiveness Rating Scale
Periodo de tiempo: This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Measures how much anxiety interferes with functioning
This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Karen Rowa, Ph. D, St. Joseph's Healthcare Hamilton

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 enero de 2016

Finalización primaria (Actual)

1 de diciembre de 2016

Finalización del estudio (Actual)

1 de diciembre de 2016

Fechas de registro del estudio

Enviado por primera vez

14 de enero de 2016

Primero enviado que cumplió con los criterios de control de calidad

15 de enero de 2016

Publicado por primera vez (Estimar)

20 de enero de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

29 de diciembre de 2016

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

28 de diciembre de 2016

Última verificación

1 de diciembre de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 0986

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. .

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