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Internet-based Cognitive Behavior Therapy for Stress Disorders: a Randomized Trial

13 de diciembre de 2019 actualizado por: Erik Hedman, Karolinska Institutet
Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering. Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited. One possible solution is to provide therapy via the Internet, which has been shown to be effective for anxiety disorders and depression. In the present study, we will investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorders and burnout syndrom in a randomized controlled trial (N=100). Participants will be randomized to active treatment (n=50) or a control condition on waiting list.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering. Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited. One possible solution is to provide therapy via the Internet, which has been shown to be effective for anxiety disorders and depression. Internet-based CBT can be described as online bibliotherapy with therapist support via a secure messaging system. In this study psychologists will deliver the treatment. We will investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorder and burnout syndrom in a randomized controlled trial (N=100). Participants will be randomized to active treatment (n=50) or a control condition on waiting list. We expect that participants who receive ICBT will make superior improvements compared to the control condition on measures of stress, burnout, depressive symptoms, general anxiety and general functioning.

Tipo de estudio

Intervencionista

Inscripción (Actual)

100

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:

To be included in the study participants must be between 18 and 65 years of age and suffer from primary stress-related disorders by meeting diagnostic criteria for adjustment disorder or burnout syndrome. Participants must have access to a computer and to the Internet, as well as being able to write and write in Swedish.

Exclusion Criteria:

Exclusion criteria include (a) meeting the criteria for another axis-1 diagnosis that is assessed to be the primary area of difficulty, (b) suffering from substance abuse/dependence in the past 6 months, (c) suffering from current or past psychosis or bipolar disorder, (d) moderate to high suicide risk, (e) initiated or changed pharmachological treatment for depression or anxiety in the past month and (f) other on-going psychological treatment for stress-related difficulties, and (g) not having received CBT for stress-related ill-health in the past year.

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

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Active treatment, Internet-based CBT
Internet-based treatment with therapist support using an asynchronous messaging system. The treatment is comprised of 12 modules (similar to chapters) and the treatment is 12 weeks long. The treatment is based on cognitive behavior therapy. Participants will be stratified based on diagnosis, i.e. adjustment disorder and burnout.
Conductual: Internet-based CBT
Internet-based treatment with therapist support using an asynchronous messaging system. The treatment is comprised of 12 modules (similar to chapters) and the treatment is 12 weeks long. The treatment is based on cognitive behavior therapy
Sin intervención: Waiting list control
The control condition is a waiting list. Participants in this arm receive no active treatment. After 12 weeks on waiting list, participants are crossed over to treatment.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Perceived stress scale (PSS)
Periodo de tiempo: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Change in PSS at post-treatment and follow-up compared to baseline
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Shirlom Melamed Burnout Questionnaire (SMBQ)
Periodo de tiempo: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Change in SMBQ at post-treatment and follow-up compared to baseline
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Insomnia Severity Index (IS)
Periodo de tiempo: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Change in ISI at post-treatment and follow-up compared to baseline
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Generalized AnxietyDisorder-7 (GAD-7)
Periodo de tiempo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in GAD-7 at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Physical Health Questionnaire-15 (PHQ-15)
Periodo de tiempo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in PHQ-15 at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Montgomery Åsberg Depression Rating Scale - self-rated (MADRS-S)
Periodo de tiempo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in MADRS-S at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Self-rated health (SRH)
Periodo de tiempo: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Change in SRH at post-treatment and follow-up compared to baseline
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Work Ability Index (WAI)
Periodo de tiempo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in WAI at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Euroqol 5 dimensions (EQ5D)
Periodo de tiempo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in EQ5D at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Brunnsviken Brief Quality of life inventory (BBQ)
Periodo de tiempo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in BBQ at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
World Health Organization Disability Assessment Schedule (WHODAS)
Periodo de tiempo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in WHODAS at post-treatment and follow-up compared to baseline.
baseline, post-treatment (12 weeks), 6 month follow-up
Alcohol Disorders Identification Test (AUDIT)
Periodo de tiempo: Baseline
This instrument will be used for screening purpose only
Baseline
Sickness questionnaire state (SQ)
Periodo de tiempo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in SQ at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Periodo de tiempo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in TIC-P at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Karolinska Sleep Questionnaire (KSQ)
Periodo de tiempo: baseline, post-treatment (12 weeks), 6 month follow-up
Change in KSQ at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Client Satisfaction Questionnaire (CSQ)
Periodo de tiempo: Post-treatment (12 weeks)
Mean and standard deviations will be presented
Post-treatment (12 weeks)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Credibility Scale (C-scale)
Periodo de tiempo: Week 2 and week 8
Measures treatment credibility. Mean scores and standard deviations will be presented
Week 2 and week 8
Change in Putative mediators
Periodo de tiempo: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Colaboradores e Investigadores

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

Patrocinador

Karolinska Institutet

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 octubre de 2015

Finalización primaria (Actual)

1 de octubre de 2017

Finalización del estudio (Actual)

1 de octubre de 2017

Fechas de registro del estudio

Enviado por primera vez

1 de septiembre de 2015

Primero enviado que cumplió con los criterios de control de calidad

2 de septiembre de 2015

Publicado por primera vez (Estimar)

3 de septiembre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de diciembre de 2019

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

13 de diciembre de 2019

Última verificación

1 de diciembre de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ICBT for stress

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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