Augmented Depression Therapy (ADepT) Case Series
28 de julio de 2026 actualizado por: Jay Fournier, Ohio State University
This research study plans to examine the use of Augmented Depression Therapy (ADepT) in order to evaluate what patients think about ADepT and how well it works. ADepT is a type of therapy that builds wellbeing and is being provided to you as standard of care.
ADepT treatment consists of 15 therapy sessions (typically provided weekly) with each session lasting around 60 minutes. Following these sessions, you can receive five optional booster sessions over the next 12 months with each of these lasting around 60 minutes. Ultimately, the timing and duration of these sessions will be determined between you and your provider and scheduled accordingly.
As part of this study you will be randomized (randomly assigned) to different research assessment lengths before the start of treatment and then will complete assessments for the 12 months following the end of the weekly portion of ADepT treatment. The length of your participation will be between 70 weeks to 82 weeks.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
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.
Estudio Contacto
- Nombre: Jay Fournier, Ph.D.
- Número de teléfono: 614-814-6485
- Correo electrónico: Jay.Fournier@osumc.edu
Ubicaciones de estudio
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Ohio
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Columbus, Ohio, Estados Unidos, 43214
- The Ohio State University Wexner Medical Center
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Contacto:
- Jay Fournier, PhD
- Número de teléfono: 614-814-6485
- Correo electrónico: jay.fournier@osumc.edu
-
-
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Aged 18 -65
- Currently experiencing a major depressive episode based on the Quick Structured Clinical Interview for DSM-5 Disorders (QuickSCID-5; First & Williams, 2021)
- Scoring > 10 on the PHQ-9
- Have sufficient knowledge of written and spoken English to provide consent and utilize therapy resources and take assessment measures throughout the protocol without the assistance of a translator.
Exclusion Criteria:
- Diagnosis of a psychotic or bipolar disorder
- History of learning disabilities or organic brain change (e.g., from injury or from neurological disorders)
- Active alcohol or substance use disorder or level of use that would interfere with ability to engage in ADepT treatment
- Current marked risk to self (self-harm or suicidal ideation) that cannot be managed safely within the ADepT treatment frame
- Patients cannot be enrolled while they are currently receiving psychotherapy from a different provider in line with current clinic policy and APA ethical guidelines. The possibility of switching providers/treatments will be addressed following established departmental policies and procedures, transcranial magnetic stimulation, ketamine, esketamine, or electroconvulsive therapy. Patients receiving a stable dose of an antidepressant agent will be considered eligible.
- Presence of another psychiatric disorder judged to be primary
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 de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 3 week baseline + ADepT
Baseline assessments will be made weekly for 3 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
Experimental: 4 week baseline + ADepT
Baseline assessments will be made weekly for 4 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
Experimental: 5 week baseline + ADepT
Baseline assessments will be made weekly for 5 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
Experimental: 6 week baseline + ADepT
Baseline assessments will be made weekly for 6 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
Experimental: 7 week baseline + ADepT
Baseline assessments will be made weekly for 7 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
Experimental: 8 week baseline + ADepT
Baseline assessments will be made weekly for 8 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Acceptability
Periodo de tiempo: From enrollment to the end of treatment at 82 weeks
|
Patient ratings of treatment acceptability
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From enrollment to the end of treatment at 82 weeks
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Attrition
Periodo de tiempo: From enrollment to the end of treatment at 82 weeks.
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Patient attendance records
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From enrollment to the end of treatment at 82 weeks.
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Adverse Events
Periodo de tiempo: From enrollment to the end of treatment at 82 weeks.
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Self-reported adverse events
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From enrollment to the end of treatment at 82 weeks.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
Periodo de tiempo: From enrollment to the end of treatment at 82 weeks.
|
The MADRS is a clinician-administered, 10-item assessment tool used to measure the severity of depressive symptoms and monitor changes in depression over time.
Min=0, Max=60, higher scores indicate worse depression.
|
From enrollment to the end of treatment at 82 weeks.
|
|
Patient Health Questionnaire - 9 Item Version (PHQ-9)
Periodo de tiempo: From enrollment to the end of treatment at 82 weeks.
|
The PHQ-9 is a 9-item self-report measure of depression severity.
Min=0, Max=27, higher scores indicate worse depression.
|
From enrollment to the end of treatment at 82 weeks.
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Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Periodo de tiempo: From enrollment to the end of treatment at 82 weeks.
|
The WEMWBS is a 14-item self-report questionnaire designed to measure positive mental wellbeing, including emotional, psychological, and social functioning.
Min=14, Max=70, higher scores indicate higher levels of wellbeing.
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From enrollment to the end of treatment at 82 weeks.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
31 de agosto de 2028
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
23 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de julio de 2026
Publicado por primera vez (Actual)
29 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20251473
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Only IRB approved personnel will have access to identifiable data.
De-identified data may be shared with other research groups examining similar questions or as a requirement for publication in certain journals.
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
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