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Internet Program for Workers With Subthreshold Depression (WorkDep)

9 de enero de 2015 actualizado por: Oregon Center for Applied Science, Inc.

Multimedia Internet-Based Program for Workers With Subthreshold Depression

Depression is one of the most prevalent mental disorders to afflict adults. It seriously impacts role functioning and often takes a recurrent or chronic course. Because most adults who suffer from depression never receive treatment, there is a critical need to develop interventions that can be easily implemented and widely disseminated. Interventions that reduce the performance-impairing symptoms of subclinical depression and prevent the onset of major depression can improve employee well-being, while reducing healthcare costs and improving productivity. This project produced a mobile-web program to activate cognitive behavioral skills in workers with subthreshold depression, reduce depression symptoms, improve functioning in the workplace, and potentially reduce the risk for escalation to full-syndrome depression.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

The responsive mobile-web MoodHacker app was designed to: (a) educate users about depression; (b) educate users about the logistics and benefits of mood and activity monitoring; (c) promote daily mood and activity monitoring; (d) help users increase their positive activity engagement; (e) help users decrease negative thinking and increase positive thinking; and (f) promote daily practice of the skills taught.

Program content was adapted from the Coping with Depression group therapy course [18], enhanced with mindfulness-based [22] and other evidence-based positive psychology strategies [23-25]. Content for the application was refined based on input from experts in the field who had extensive experience working with adult employees at risk for depression. Additional program modifications were made based on data from individual interviews and iterative user testing with the population of interest during the formative and production phases of the project.

The MoodHacker user experience is structured around twelve learning objectives delivered through daily emails, in-app messaging, and in the "Articles & Videos" library. Daily emails (Figure 1) are sent to engage users in program content, provide sequenced guidance through the learning objectives in the articles and whiteboard-style videos, give tips for getting the most out of MoodHacker, and prompt the user to track their mood and activities daily. Users are encouraged to view the articles and videos as ordered, but viewing is not restricted, and users can view content according to their interest. The emails, articles and videos promote practice of the featured cognitive and behavioral skills outside the app experience.

Tipo de estudio

Intervencionista

Inscripción (Actual)

300

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 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • 18 years or older
  • mild-to-moderate depressive symptoms as measured by the PHQ-9 (score of 10-19)
  • not currently suicidal or meeting criteria for bipolar or schizo-affective disorder
  • employed at least part-time
  • English speaking
  • access to a high-speed internet connection

Exclusion Criteria:

  • younger than 18 years old
  • severe depressive symptoms as measured by the PHQ-9 (score of 20+)
  • currently suicidal or meeting criteria for bipolar or schizo-affective disorder
  • employed less than part-time or unemployed
  • not English speaking
  • no access to a high-speed internet connection

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

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

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: MoodHacker
Participants in the treatment condition were emailed a link to the MoodHacker mobile-web app and instructed to use the program for the next six weeks. Participants were asked to complete 2 follow-up assessments, 6 weeks and 10 weeks after baseline.
Mobile-web app to educate users about depression and promote daily mood and positive activity monitoring.
Otros nombres:
  • Internet program for workers with subthreshold depression
Comparador activo: Alternative Care
Alternative care participants were emailed and encouraged to browse links to vetted online information about depression. Participants were asked to complete 2 follow-up assessments, 6 weeks and 10 weeks after baseline and were given access to the MoodHacker program after the 10-week assessment
Online information about depression from government and other trusted sources to educate users about depression.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Depression symptoms as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: 10 week follow-up
Depressive symptomatology was assessed at each assessment point using the self-reported Patient Health Questionnaire-9 scale to assess the nine DSM-IV major depression symptoms. The PHQ-9 is a self-report version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) and has been shown to be a reliable and valid brief depression assessment tool.
10 week follow-up

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Activation of positive self-care and life-choice behaviors
Periodo de tiempo: 6-week posttest and 10-week follow-up
How actively individuals are taking care of themselves, including making positive life choices, was expected to increase as a result of the intervention. Behavioral activation was measured using the Behavioral Activation for Depression Scale Short Form (BADS). This scale consists of 9 items.
6-week posttest and 10-week follow-up
Change in negative thinking
Periodo de tiempo: 6-week posttest and 10-week follow-up
Change in negative thinking was assessed using the Automatic Thoughts Questionnaire - Revised scale Short Form (ATQ-R-SF). A 12-item adaptation of the ATQ-R instrument asked respondents to rate how many times over the past week they have had thoughts that are consistent with 12 negative self-statements.
6-week posttest and 10-week follow-up
Knowledge about depression
Periodo de tiempo: 6-week posttest and 10-week follow-up
Treatment participants were assessed for an increase in knowledge about depression. The scale consisted of 14 multiple-choice items based on the 12 learning objectives addressed in the MoodHacker articles and videos.
6-week posttest and 10-week follow-up
Worker productivity as assessed by the Work Limitations Questionnaire
Periodo de tiempo: 6-week posttest and 10-week follow-up
Worker productivity was assessed using the Work Limitations Questionnaire (WLQ). The WLQ Short Form consists of 10 items divided into four subscales measuring the degree to which a person was limited in their job's (1) time demands; (2) physical demands; (3) mental demands; and (4) output demands.
6-week posttest and 10-week follow-up
Worksite outcomes as assessed by the Workplace Outcomes Suite
Periodo de tiempo: 6-week posttest and 10-week follow-up
Worksite outcomes were also assessed using the Workplace Outcomes Suite (WOS). The WOS is designed as an open-access instrument to facilitate empirical research on Employee Assistance Program (EAP) interventions. The suite contains five 5-item scales that assess: absenteeism, presenteeism, work engagement, life satisfaction, and workplace distress.
6-week posttest and 10-week follow-up
User satisfaction as assessed by the System Usability Scale
Periodo de tiempo: 6 week posttest
Treatment participants completed the System Usability Scale, which is a quantitative measure of program ease of use. The scale includes 10 items. Users were asked to what degree they agreed or disagreed with program use and satisfaction statements on a 6-point scale (1=strongly disagree; 6=strongly agree).
6 week posttest

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Amy J Birney, MPH, MCHES, Oregon Center for Applied Science

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.

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 agosto de 2012

Finalización primaria (Actual)

1 de junio de 2013

Finalización del estudio (Actual)

1 de junio de 2013

Fechas de registro del estudio

Enviado por primera vez

7 de enero de 2015

Primero enviado que cumplió con los criterios de control de calidad

8 de enero de 2015

Publicado por primera vez (Estimar)

9 de enero de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

12 de enero de 2015

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

9 de enero de 2015

Última verificación

1 de enero de 2015

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 81RR-2R

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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