Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Internet Intervention for the Prevention of Depression - Approaches to Improving Mood (AIM)

29 de junio de 2012 actualizado por: David Mohr, Northwestern University

Technology Assisted Behavioral Intervention for the Prevention of Depression

This study will develop and evaluate the effectiveness of a technology-assisted behavioral intervention, consisting of Internet-based cognitive behavioral therapy combined with telephone and email support, in preventing depressive symptoms and improving treatment adherence in individuals at risk of major depressive disorder.

Descripción general del estudio

Descripción detallada

Depression is common, with one-year prevalence rates of major depressive disorder (MDD) estimated to be between 6.6-10.3% in the general population. Depression imposes a very high societal burden in terms of cost, morbidity, suffering, and mortality. Yet only about 20% of all patients referred for psychotherapy ever enter treatment, and of those who initiate treatment, nearly half drop out before completion. Given the limitations of treatment and the significant burden of depression, research into the prevention of depression is needed. There is a dearth of research related to the effective prevention of depression.

Delivering an intervention through telecommunication technologies, such as the telephone and Internet, has the potential to overcome many of the barriers to existing depression prevention interventions. For example, telephone- and Web-based interventions can reduce cost, extend specialized treatment over broad geographic areas, and permit considerable flexibility in scheduling of treatment components. Approaches to Improving Mood (AIM) is a specific form of a telecommunication behavioral intervention that incorporates Web-based Internet, e-mail, and telephone intervention. Further study is needed to determine the effectiveness of AIM in preventing depressive symptoms and improving attrition from treatment rates in people at risk for MDD. The study will compare the effectiveness of the AIM program with a one year surveillance follow up with the effectiveness of the AIM program alone and a website offering information on depression prevention in preventing depressive symptoms and improving treatment adherence in individuals at risk of MDD.

Participation in the treatment phase of this study will last 12 weeks. All participants will first undergo initial assessments that will include a telephone interview and a series of questionnaires about mood. Eligible participants will then be assigned randomly to receive AIM + surveillance, AIM alone, or the education website. All participants will undergo 12 weeks of a Web-based Internet intervention consisting of modules to help them learn skills to manage their moods. Participants will be asked to access the Web site every day or two to complete the modules and to practice the learned techniques. Participants assigned to AIM + surveillance and AIM alone will also receive a weekly telephone-based motivational intervention from a coach and will be able to communicate with the coach via email throughout the first 12 weeks of treatment. Participants assigned to the education group will be given access to a website but no assistance from a coach. All participants will undergo repeat initial assessments at Weeks 6, 12 (end of treatment) and at 3 months, 6 months, 9 months and 12 months following the completion of treatment.

Tipo de estudio

Intervencionista

Fase

  • Fase 1

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

    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Northwestern University

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

19 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • PredictD Risk Score of .130
  • Has a telephone, e-mail account, computer, and broadband access to the Internet.
  • Is able to speak and read English.
  • Is at least 19 years of age.
  • Is able to give informed consent.

Exclusion Criteria:

  • Has DSM-IV diagnosis of Major Depressive Episode assessed using the MINI
  • Has hearing or voice impairment that would prevent participation in psychotherapy.
  • Has visual impairment that would prevent use of the workbook and completion of assessment materials.
  • Meets criteria for dementia by scoring < 25 on the Telephone Interview for Cognitive Status (TICS).
  • Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current post-traumatic stress disorder (PTSD), current substance abuse, or other diagnosis for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous. Patients with substance abuse diagnoses who have been clean and sober for 3 months will be admitted if otherwise eligible.
  • Is currently receiving individual psychotherapy or planning to receive psychotherapy during the 12-week treatment phase of the study.
  • Is planning to be out of town or unavailable for treatment for 4 weeks or more during the scheduled treatment time.
  • Exhibits severe suicidality, including ideation, plan, and intent.
  • Has initiated treatment with an antidepressant in past 10 days. Once patients have been on a stable dose for 10 days and do not have an appointment with a physician or psychiatrist to change this dose, the patient will be eligible based on this criterion.

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: AIM + surveillance
Participants will receive access to the AIM website and calls from a motivational coach for 12 weeks plus an additional year of surveillance and optional coach support.
The web based intervention will include 12 weeks of Internet-based cognitive behavioral therapy combined with brief telephone and email support from a coach. Surveillance will consist of monthly screening of depression symptoms and outreach from the coach should there be an increase in symptoms.
Experimental: AIM intervention
Participants will receive access to the AIM web based intervention and calls from a motivational coach for 12 weeks
The web based intervention will include 12 weeks of Internet-based cognitive behavioral therapy combined with brief telephone and email support from a coach.
Comparador activo: Educational website
Participants will be given access to a static website with depression prevention related materials and handouts.
Participants will receive access to a static educational website for 12 weeks.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Depression, as assessed by Quick Inventory of Depressive Symptoms (QIDS), the Patient Health Questionnaire-9 (PHQ-9), and the Mini International Neuropsychiatric Interview (MINI) Disorders-Major Depressive Disorders Module
Periodo de tiempo: Measured at baseline, week 6, week 12 and month 3, month 6, month 9 and month 12
Measured at baseline, week 6, week 12 and month 3, month 6, month 9 and month 12
Website utilization (e.g., number of logins, average visit length, total time spent on the site, number of exercises completed), Attrition and cost effectiveness.
Periodo de tiempo: From baseline through 12 month follow-up
From baseline through 12 month follow-up

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Anxiety, impact on work, social support
Periodo de tiempo: Measured at baseline, week 6, week 12 and month 3, month 6, month 9 and month 12
Measured at baseline, week 6, week 12 and month 3, month 6, month 9 and month 12

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: David C. Mohr, Ph.D., Northwestern University

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 junio de 2012

Finalización primaria (Anticipado)

1 de diciembre de 2013

Finalización del estudio (Anticipado)

1 de diciembre de 2013

Fechas de registro del estudio

Enviado por primera vez

2 de marzo de 2010

Primero enviado que cumplió con los criterios de control de calidad

2 de marzo de 2010

Publicado por primera vez (Estimar)

3 de marzo de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

3 de julio de 2012

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

29 de junio de 2012

Última verificación

1 de junio de 2012

Más información

Términos relacionados con este estudio

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 AIM Web based intervention + surveillance

3
Suscribir