- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01901796
Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT) Full Trial
Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT): Intervening Early to Improve Maternal and Family Well-being.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
One of the main reasons that women do not receive treatment is that their mood and anxiety problems are not detected. Despite recommendations and high rates of acceptance by providers and women, only a minority of providers conduct psychosocial assessments as part of routine prenatal care. Computer-based 'screening' is an acceptable and feasible approach to assessment of sensitive issues including prenatal and postnatal intimate partner violence, mental health problems, and postpartum depression by patients and providers. It is well-suited for busy clinical settings and is advantageous in that it offers a consistent approach to assessment, is resource-sparing, can be tailored to meet the specific needs of patients, can be used with audio/video for low literacy, provides a real-time summary for patients/providers,achieves similar or higher rates of disclosure of violence and mental health problems, and is preferred by patients because they perceive it as more anonymous compared to interviews or questionnaires.
However, psychosocial assessment on its own is ineffective in preventing or treating mood disorders and unethical in the absence of treatment options. As such, many providers do not assess pregnant women for mood disorders because non-pharmacological treatments are frequently unavailable and pregnant women prefer them. Cognitive behavioural therapy (CBT) is a highly effective, non-pharmacological treatment for depression and anxiety and is recommended by perinatal national Australian guidelines as a potentially effective EARLY intervention for reducing the risk of maternal-child outcomes.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Alberta
-
Stony Plain, Alberta, Canadá, T7Z 2M7
- Westview Health Centre
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
Pregnant women will be eligible for Phase 2 if they are:
- < 28 weeks gestation (to provide the opportunity to complete 6 modules and follow-up questionnaires prior to delivery)
- able to speak/read English; and (3) willing to complete email questionnaires
Exclusion Criteria:
- >28 weeks gestation
- unable to speak/read English
- unable to complete email questionnaires
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Screening and CBT
Screening and Cognitive Behavioral Therapy.
The intervention group will be screened and if they need criteria they will complete the 6, 30-minute online, interactive CBT modules over 6 weeks.
|
Cognitive Behavioral Therapy- an effective, non-pharmacological treatment for depression and anxiety.
|
Sin intervención: Usual care
Usual prenatal care
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The primary outcome of this study is the feasibility/acceptability of integrated psychosocial care and its components.
Periodo de tiempo: 6 weeks post randomization
|
Feasibility/acceptability of the intervention will be assessed through individual face-to-face or telephone-based semi-structured qualitative interviews of both clinic staff and women in the intervention group.
The field does not allow for all questions to be provided.
Sample question for clinic staff is 'What aspects made it easy/challenging to use the tablet for prenatal assessment as part of routine prenatal care?' Sample questions for intervention group participants: 1)How did you feel about answering these kinds of questions on a tablet?; 2)Please describe any concerns you had about answering these questions on a tablet; 3)How would you prefer the results to be shared with you
|
6 weeks post randomization
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Maternal depression, anxiety, stress
Periodo de tiempo: on recruitment, 6 weeks post randomization and 3 months postpartum
|
Depression, Anxiety, and Stress Scale (DASS-21) Self-reported by mother on emailed questionnaire
|
on recruitment, 6 weeks post randomization and 3 months postpartum
|
Maternal coping
Periodo de tiempo: on recruitment, 6 weeks post-randomization and 3 months postpartum
|
The Brief Cope Self-reported by mother on emailed questionnaire
|
on recruitment, 6 weeks post-randomization and 3 months postpartum
|
Relationship Adjustment
Periodo de tiempo: on recruitment, 6 weeks post-randomization and 3 months postpartum
|
Scale: Dyadic Adjustment Scale, DAS-7 Self-reported by mother on emailed questionnaire
|
on recruitment, 6 weeks post-randomization and 3 months postpartum
|
Parenting Stress
Periodo de tiempo: 3 months postpartum
|
Parenting Stress Scale Self-reported by mother
|
3 months postpartum
|
Parenting competence
Periodo de tiempo: 3 months postpartum
|
Parenting Sense of Competence Scale Self-reported by mother on emailed questionnaire
|
3 months postpartum
|
Maternal-infant attachment
Periodo de tiempo: 3 months postpartum
|
Maternal Attachment Inventory (MAI) Self-reported by mother on emailed questionnaire
|
3 months postpartum
|
Trait anxiety
Periodo de tiempo: on recruitment, 6 weeks postrandomization, 3 months postpartum
|
State Trait Anxiety Inventory (STAI) Self-reported by mother on emailed questionnaire
|
on recruitment, 6 weeks postrandomization, 3 months postpartum
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dawn A Kingston, Ph.D, University of Calgary
Publicaciones y enlaces útiles
Publicaciones Generales
- Bright KS, Stuart S, Mcneil DA, Murray L, Kingston DE. Feasibility and Acceptability of Internet-Based Interpersonal Psychotherapy for Stress, Anxiety, and Depression in Prenatal Women: Thematic Analysis. JMIR Form Res. 2022 Jun 10;6(6):e23879. doi: 10.2196/23879.
- Bright KS, Mughal MK, Wajid A, Lane-Smith M, Murray L, Roy N, Van Zanten SV, Mcneil DA, Stuart S, Kingston D. Internet-based interpersonal psychotherapy for stress, anxiety, and depression in prenatal women: study protocol for a pilot randomized controlled trial. Trials. 2019 Dec 30;20(1):814. doi: 10.1186/s13063-019-3897-z.
- Kingston D, Austin MP, Hegadoren K, McDonald S, Lasiuk G, McDonald S, Heaman M, Biringer A, Sword W, Giallo R, Patel T, Lane-Smith M, van Zanten SV. Study protocol for a randomized, controlled, superiority trial comparing the clinical and cost- effectiveness of integrated online mental health assessment-referral-care in pregnancy to usual prenatal care on prenatal and postnatal mental health and infant health and development: the Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT). Trials. 2014 Mar 6;15:72. doi: 10.1186/1745-6215-15-72.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 00036912
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. .
Ensayos clínicos sobre Cognitive Behavioral Therapy
-
University of OxfordOxford University Hospitals NHS TrustDesconocidoSíntomas de comportamientoReino Unido
-
Assistance Publique - Hôpitaux de ParisAún no reclutandoPérdida de la audición | Función cognitiva | Función ejecutiva | Función vestibularFrancia
-
NeuroTronik Inc.DesconocidoInsuficiencia cardiaca | Insuficiencia cardíaca agudaParaguay
-
University of Roma La SapienzaTerminadoImplante dental fallido | Mucositis BucalItalia
-
NeuroTronik Inc.DesconocidoTerapia de estimulación autónoma del gasto cardíaco para la insuficiencia cardíaca aguda (COAST-AHF)Insuficiencia cardíaca agudaPanamá
-
Vyaire MedicalAún no reclutandoSíndrome de insuficiencia respiratoria del recién nacidoItalia
-
Boston Children's HospitalTerminadoEstrés Psicológico | Problema de aculturaciónEstados Unidos
-
Abbott Medical DevicesTerminadoFlutter auricular típicoEstados Unidos, Canadá
-
Abbott Medical DevicesTerminadoFibrilación auricular paroxísticaAustralia, Alemania, Francia, Italia, Portugal, Reino Unido
-
Square2 Systems, Inc.National Institute on Drug Abuse (NIDA)ReclutamientoTrastornos relacionados con sustancias | Trastornos por uso de sustanciasEstados Unidos