- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07577947
Health And Response: Digital Markers for Outcomes in Perinatal Depression Treatment Study (HARMONY)
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Eliza Congdon, PhD
- Número de teléfono: (310)-339-9053
- Correo electrónico: harmonystudy@mednet.ucla.edu
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90095
- University of California, Los Angeles
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Investigador principal:
- Nelson Freimer, MD
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Contacto:
- Eliza Congdon
- Número de teléfono: (310)-339-9053
- Correo electrónico: harmonystudy@mednet.ucla.edu
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- At least 18 years of age
- Able to read and communicate in English
- Between 28 weeks pregnant and 12 weeks postpartum
- Moderate-to-severe depression, as defined by Edinburgh Postnatal Depression Scale (EPDS) score ≥11
- Not currently seeing a provider for mental health care
- Own functioning iOS smartphone (iPhone 11 or newer, iOS 18 or newer) with access to reliable data plan and Wifi)
- Able to read and understand a written informed consent form
- Willingness to participate in treatment through the study and follow all study procedures, including providing HIPAA Authorization for research, installing a study app on personal iPhone, and wearing the provided Apple Watch for at least 20 hours every day in the first four weeks of the study (including while sleeping)
Exclusion Criteria:
- Currently receiving treatment by a therapist or a psychiatrist
- Unstable suicidality (e.g., 2 or more suicide attempts or self-injurious behaviors resulting in hospitalization in the last 6 months)
- Current substance use disorder that interferes with treatment: specifically, patients meeting diagnostic criteria for Substance Use Disorder (SUD) will be eligible for inclusion only if they are able to attend sessions while not under the influence of that substance, with the exception of individuals abusing opiates or freebase cocaine, who will be excluded
- Principal diagnosis of psychosis unrelated to depression (unipolar or bipolar)
- Neurological conditions
- Severe uncontrolled medical conditions (e.g., anorexia nervosa, cardiac conditions requiring continuous monitoring)
- Cognitive impairment (e.g., developmental disability, dementia)
- Previously participated in the UCLA Depression Grand Challenge "New Moms Mood Tracking & Wellbeing Study" (IRB #20-001924)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Tier 2 - PND Digital Therapy with Coaching
Participants with a recent EPDS score in the moderate range (11-18) and no current suicidality will be given access to a perinatal depression online cognitive-behavioral therapy course (the ParentMood program).
Some of the lesson content is presented as illustrated videos.
Following each lesson, participants can download a document that summarizes the key information in each lesson, and which includes practical homework exercises that reinforce the content of the lesson.
Participants are encouraged to practice their lesson homework for at least one week before starting the next lesson.
Lessons will be completed sequentially.
Participants have the option of accessing the content through a web-browser.
Participants may receive up to 9 coaching sessions with their assigned Coach, in addition to an initial Orientation session, which will occur through secure video conference.
The initial Orientation session is required, but the additional coaching sessions thereafter are optional.
|
Participants with a recent EPDS score in the moderate range (11-18) and no current suicidality will be given access to a perinatal depression online cognitive-behavioral therapy course (the ParentMood program).
Some of the lesson content is presented as illustrated videos.
Following each lesson, participants can download a document that summarizes the key information in each lesson, and which includes practical homework exercises that reinforce the content of the lesson.
Participants are encouraged to practice their lesson homework for at least one week before starting the next lesson.
Lessons will be completed sequentially.
Participants have the option of accessing the content through a web-browser.
Participants may receive up to 9 coaching sessions with their assigned Coach, in addition to an initial Orientation session, which will occur through secure video conference.
The initial Orientation session is required, but the additional coaching sessions thereafter are optional.
|
|
Comparador activo: Tier 3 - Clinical Care
Participants with a recent EPDS score in the severe range (19-30) and/or significant suicidality with intent or means will be given access to a clinical care, which entails weekly psychotherapy sessions. The number and schedule of psychotherapy sessions in the study is determined by the clinical care team. Treatment appointments will occur through secure video conference. If the clinical team believes that consultation with a psychiatrist is warranted, a referral will be made to a UCLA Health clinic (e.g., the MOMS Clinic) for a consultation session and possible pharmacotherapy. |
Participants with a recent EPDS score in the severe range (19-30) and/or significant suicidality with intent or means will be given access to a clinical care, which entails weekly psychotherapy sessions.
The number and schedule of psychotherapy sessions in the study is determined by the clinical care team.
Treatment appointments will occur through secure video conference.
If the clinical team believes that consultation with a psychiatrist is warranted, a referral will be made to a UCLA Health clinic (e.g., the MOMS Clinic) for a consultation session and possible pharmacotherapy.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Edinburgh Postnatal Depression Scale (EPDS) total score
Periodo de tiempo: From enrollment through the twelve weeks of the study.
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Self-reported depression symptom severity scores
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From enrollment through the twelve weeks of the study.
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Percent change in EPDS scores
Periodo de tiempo: From enrollment through the twelve weeks of the study.
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Percent change in self-reported depression symptom severity scores (as measured with EPDS)
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From enrollment through the twelve weeks of the study.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Treatment retention, as defined by number of coaching or therapy sessions attended by participants
Periodo de tiempo: From week 2 through week 13 of the study
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Measure of treatment retention, as defined by number of coaching or therapy sessions attended.
A participant is considered to have been retained in treatment if they completed number of sessions advised by their therapist, or to have not been categorized as dropping from treatment early.
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From week 2 through week 13 of the study
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Treatment retention, as defined by whether the participant completed treatment or not
Periodo de tiempo: From week 2 through week 13 of the study
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Measure of treatment retention, as defined by whether the participant completed treatment or not
|
From week 2 through week 13 of the study
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michelle G Craske, PhD, University of California, Los Angeles
- Investigador principal: Nelson Freimer, MD, University of California, Los Angeles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 25-2121
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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