- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01935375
Multidisciplinary Model of Nurse Midwife
Multidisciplinary Model of Nurse Midwife Psychotherapy for Postpartum Depression
HYPOTHESES:
The hypotheses are that:
- nurse midwives will be able to safely deliver interpersonal psychotherapy by telephone to women with postpartum depression
- women receiving interpersonal psychotherapy will have less symptoms of postpartum depression, better functioning, better bonding with their babies, and better relationships with their partners
- women with postpartum depression will be more satisfied with their care than women in the group that was referred to a mental health center.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The specific aims of this pilot non-randomized clinical trial are to evaluate among women with PPD recruited between 6 and 24 weeks postpartum:
- The (a) feasibility, (b) acceptability and (c) safety of a psychological intervention (Interpersonal Psychotherapy [IPT]) provided by nurse midwives in collaboration with a mental health team (psychiatrist team leader and a licensed social worker) for treatment of PPD in a pilot two-armed non-randomized clinical trial.
- The preliminary evidence of efficacy of IPT in decreasing depressive symptoms when administered via telephone by nurse-midwives/ women's health nurse practitioner
The proposed study will also evaluate preliminary evidence for the efficacy of IPT administered by nurse midwives in
- Improving the general level of maternal functioning
- Specific improvement in marital adjustment
- Increase in maternal infant bonding
This pilot study is the first step in developing an intervention to decrease depressive symptoms, improve functioning, improve interpersonal relationships between mother and spouse and infant, improve access to care, and improve treatment engagement among postpartum women diagnosed with PPD. The intervention will be cost-effective, brief and acceptable to both patients and nurse midwives for incorporation into current midwifery practice. If the IPT program is found to be feasible, acceptable and safe with preliminary evidence of efficacy, a postpartum IPT manual for advanced practice nurses will be finalized in order to test whether other advanced practice nurses such as pediatric nurse practitioners and family nurse practitioners can also safely and effectively administer IPT in a full-scale randomized clinical trial
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Pennsylvania
-
Phila, Pennsylvania, Estados Unidos, 19102
- Drexel University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 6 to 24 weeks postpartum
- 16 years and older
- English-speaking
- Have access to a telephone
- Consents to enter the trial
- Postpartum onset of postpartum depression
- Current use of antidepressant medication as long as dose does not have to be adjusted by subject's healthcare provider during clinical trial
Exclusion Criteria:
- Infant complications requiring medical care beyond 6 weeks postpartum
- Infant birth defects
- Infant being placed for adoption by 6 weeks postpartum
- Maternal mental retardation
- Current use of antidepressant medication that requires dosage adjustment by subject's healthcare provider during clinical trial
- Diagnosis of depression prior to postpartum period
- Active substance or alcohol abuse or dependence
- Active suicidality, homicidality, or current psychosis as assessed by the MINI
- Disabling pain that interferes with the ability to carry out activities of daily living
- Concurrent serious medical co-morbidities (e.g. active lupus, multiple sclerosis, severe cardiac disease severe hypertension, cancer, etc).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: CNM Interpersonal Psychotherapy
CNM Interpersonal psychotherapy
|
Eight Weekly 50 minute sessions CNM Interpersonal Psychotherapy
|
|
Comparador activo: Treatment as Usual
Treatment as Usual is psychotherapy with a mental health provider
|
Treatment as Usual is psychotherapy provided by a mental health provider
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hamilton Rating Scale for depression
Periodo de tiempo: 12 weeks
|
Measure of depression severity
|
12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Global Assessment of functioning
Periodo de tiempo: 12 weeks
|
Measure of functional status
|
12 weeks
|
|
Dyadic Adjustment Scale
Periodo de tiempo: 12 weeks
|
Measure of dyadic adjustment of marital couple
|
12 weeks
|
|
Social Support Questionnaire
Periodo de tiempo: 12 weeks
|
Measure of improvement in social support
|
12 weeks
|
|
Client Satisfaction Questionnaire
Periodo de tiempo: 12 weeks
|
Measure of client satisfaction with midwife counseling
|
12 weeks
|
|
Edinburgh Postnatal Depression Scale
Periodo de tiempo: 12 weeks
|
Measure of severity of postpartum depression
|
12 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Barbara E Posmontier, PHD, Drexel University
- Investigador principal: Richard Neugebauer, PhD, Columbia University
- Investigador principal: Rita Shaughnessy, PhD, MD, Drexel University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- 18981
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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