Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance
24 de enero de 2019 actualizado por: Zindel Segal, University of Toronto
Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance.
Many patients report residual depressive symptoms despite seemingly successful treatment.
With the investigators' previous funding, we developed - Mindful Mood Balance - an online treatment that targets RDS by teaching specific emotion regulation and depression self-management skills that are entirely compatible with antidepressant treatment.
The investigators now propose a controlled study to determine whether MMB is more effective than usual care at reducing RDS and other key outcomes.
If successful, MMB's online delivery format would provide high fidelity and low-cost empirically supported management of residual symptoms, leading to more robust remission, improved functioning and sustained recovery from MDD over time.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
Residual depressive symptoms (RDS) following remission of major depressive disorder (MDD) are reported by 80-90% of adults receiving first-line antidepressant pharmacotherapy and carry an elevated risk for a chronic course of illness, rapid relapse and functional impairment. Strategies for managing residual symptoms, however, have met with mixed success. Mindful Mood Balance (MMB; R34 MH0877223) is an individually tailored, web-based treatment designed to train remitted depressed patients to disengage from dysphoria-activated depressogenic thinking that perpetuates RDS and increases risk for relapse/recurrence. MMB was developed to increase access to Mindfulness-Based Cognitive Therapy (MBCT; R01 MH066992), an empirically supported prophylactic group treatment that can be easily sequenced with acute phase antidepressant pharmacotherapy. Results from our open trial of MMB (N=100) showed an effect size of d=1.09 for pre to post treatment reductions in depression scores among patients with RDS and d=1.54 in a quasi-experimental comparison to patients receiving usual care, with an on average reduction of 1.98 points on the PHQ-9 for MMB patients. The investigators now propose a pragmatic randomized clinical trial of MMB to evaluate its effectiveness in reducing RDS in recurrently depressed patients. Patients will be members of Kaiser-Permanente Colorado (N = 460), aged 18 to 75, who score >5 and <9 on the PHQ-9, in remission from MDD and will be randomized 1:1 to either the usual depression care pathway (DepCare) or Mindful Mood Balance (MMB)+DepCare.
The investigators plan to test whether patients receiving MMB+DepCare will show greater reductions in RDS at both 8 week and 12 months follow up, than those receiving DepCare alone. The investigators are also interested in examining whether fewer patients in MMB+DepCare will relapse over the follow up and will have higher end state functioning and quality of life. In order to examine the costs associated with adding this online treatment to the Depression Care Pathways at KPCO, the investigators will calculate the marginal costs per additional number of depression free days (DFDs) for patients. Resolution of RDS can reduce the enormous personal and social costs experienced by Americans with this persistent symptom burden.
Tipo de estudio
Intervencionista
Inscripción (Actual)
460
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
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Colorado
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Denver, Colorado, Estados Unidos, 80237-8066
- Kaiser Permanente Institute for Health Research
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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 y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients with a PHQ-9 score between 5 and 9
- At least one prior episode of MDD
Exclusion Criteria:
- presence of schizophrenia or current psychosis, organic mental disorder or pervasive developmental delay
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Mindful Mood Balance
An 8 session internet intervention targeting residual depressive symptoms.
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Usual Depression Care will be based on the Kaiser Permanente Adult Depression National Guidelines - an adaptation of STAR*D (Rush et al., 2006) for antidepressant management and the IMPACT (Unitzer et al., 2002; 2008) model for therapy.
Mindful Mood Balance is an individually tailored, web-based version of Mindfulness-Based Cognitive Therapy, a manualized, group skills training program (Segal et al., 2002) that is based on an integration of aspects of cognitive therapy for depression (Beck, 1979) with components of the mindfulness-based stress reduction program (Kabat-Zinn, 1990).
Patients participated in 8 internet sessions, each of which incorporates didactic and experiential learning, along with home practice of skills taught in the program.
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Comparador activo: Usual Depression Care
Usual Depression Care through Kaiser Permanente Colorado
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Usual Depression Care will be based on the Kaiser Permanente Adult Depression National Guidelines - an adaptation of STAR*D (Rush et al., 2006) for antidepressant management and the IMPACT (Unitzer et al., 2002; 2008) model for therapy.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient Health Questionnaire-9
Periodo de tiempo: Change from Baseline to 12 weeks and 15 months
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Changes in self reported depressive symptom severity
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Change from Baseline to 12 weeks and 15 months
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Patient Health Questionnaire-9
Periodo de tiempo: Between 12 weeks and 15 months
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Rates of depressive relapse, defined as patients who score 15 or greater on the PHQ-9
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Between 12 weeks and 15 months
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Patient Health Questionnaire-9
Periodo de tiempo: Between baseline to 12 weeks.
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Conversion from moderate/high risk to low risk symptom categories, defined as a patient whose PHQ-9 score drops from a baseline PHQ-9 score between 5 and 9 to a mean score of 4 or less
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Between baseline to 12 weeks.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Ruminative Responses Scale
Periodo de tiempo: Change from Baseline to 6 weeks, 12 weeks and 15 months
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A self-report measure of rumination
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Change from Baseline to 6 weeks, 12 weeks and 15 months
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Five Facet Mindfulness Questionnaire
Periodo de tiempo: Change from Baseline to 6 weeks, 12 weeks and 15 months
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Self report measure of mindful awareness
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Change from Baseline to 6 weeks, 12 weeks and 15 months
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Five Facet Mindfulness Scale
Periodo de tiempo: Change from Baseline to 6 weeks, 12 weeks and 15 months
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Self report measure of mindful awareness
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Change from Baseline to 6 weeks, 12 weeks and 15 months
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Experiences Questionnaire
Periodo de tiempo: Change from Baseline to 6 weeks, 12 weeks and 15 months
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Self report measure of decentering/wider awareness
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Change from Baseline to 6 weeks, 12 weeks and 15 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Depression Free Days
Periodo de tiempo: Change from Baseline to 12 weeks and 15 months
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Self report of days free of depression
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Change from Baseline to 12 weeks and 15 months
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Generalized Anxiety Disorder Assessment - 7
Periodo de tiempo: Change from Baseline to 12 weeks and 15 months
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Self report measure of generalized anxiety
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Change from Baseline to 12 weeks and 15 months
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Short Form Health Survey - 12
Periodo de tiempo: Change from Baseline to 12 weeks and 15 months
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Self report measure of physical and mental health
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Change from Baseline to 12 weeks and 15 months
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Emotion Dot Probe Task
Periodo de tiempo: Change from Baseline to 12 weeks and 15 months
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A behavioural measure of attentional bias
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Change from Baseline to 12 weeks and 15 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Zindel V Segal, PhD, University of Toronto
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
- Boggs JM, Beck A, Felder JN, Dimidjian S, Metcalf CA, Segal ZV. Web-based intervention in mindfulness meditation for reducing residual depressive symptoms and relapse prophylaxis: a qualitative study. J Med Internet Res. 2014 Mar 24;16(3):e87. doi: 10.2196/jmir.3129.
- Segal ZV, Bieling P, Young T, MacQueen G, Cooke R, Martin L, Bloch R, Levitan RD. Antidepressant monotherapy vs sequential pharmacotherapy and mindfulness-based cognitive therapy, or placebo, for relapse prophylaxis in recurrent depression. Arch Gen Psychiatry. 2010 Dec;67(12):1256-64. doi: 10.1001/archgenpsychiatry.2010.168.
- Dimidjian S, Beck A, Felder JN, Boggs JM, Gallop R, Segal ZV. Web-based Mindfulness-based Cognitive Therapy for reducing residual depressive symptoms: An open trial and quasi-experimental comparison to propensity score matched controls. Behav Res Ther. 2014 Dec;63:83-9. doi: 10.1016/j.brat.2014.09.004. Epub 2014 Sep 18.
- Boggs JM, Ritzwoller DP, Beck A, Dimidjian S, Segal ZV. Cost-Effectiveness of a Web-Based Program for Residual Depressive Symptoms: Mindful Mood Balance. Psychiatr Serv. 2022 Feb 1;73(2):158-164. doi: 10.1176/appi.ps.202000419. Epub 2021 Jul 29.
- Segal ZV, Dimidjian S, Beck A, Boggs JM, Vanderkruik R, Metcalf CA, Gallop R, Felder JN, Levy J. Outcomes of Online Mindfulness-Based Cognitive Therapy for Patients With Residual Depressive Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Jun 1;77(6):563-573. doi: 10.1001/jamapsychiatry.2019.4693. Erratum In: JAMA Psychiatry. 2020 May 1;77(5):545.
Enlaces Útiles
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 (Actual)
1 de marzo de 2015
Finalización primaria (Actual)
1 de noviembre de 2018
Finalización del estudio (Actual)
1 de noviembre de 2018
Fechas de registro del estudio
Enviado por primera vez
10 de julio de 2014
Primero enviado que cumplió con los criterios de control de calidad
11 de julio de 2014
Publicado por primera vez (Estimar)
15 de julio de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
24 de enero de 2019
Última verificación
1 de enero de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01MH102229-01A1 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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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