Viewing Study NCT01901796



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Study NCT ID: NCT01901796
Status: UNKNOWN
Last Update Posted: 2019-11-13
First Post: 2013-07-10

Brief Title: Integrated Maternal Psychosocial Assessment to Care Trial IMPACT Full Trial
Sponsor: University of Calgary
Organization: University of Calgary

Study Overview

Official Title: Integrated Maternal Psychosocial Assessment to Care Trial IMPACT Intervening Early to Improve Maternal and Family Well-being
Status: UNKNOWN
Status Verified Date: 2019-11
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: We hypothesize that the intervention will 1 offer a feasible approach for providing mental healthcare to pregnant women and have a high level of acceptability by pregnant women and healthcare providers 2 reduce symptoms of depression stress anxiety and parenting stress improve parenting competence coping and relationship adjustment compared to usual care and 3 reduce the risk of poor maternal-infant attachment As such this early intervention holds promise for reducing maternal mental health morbidity and its negative influences on infants children and families
Detailed Description: 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 audiovideo for low literacy provides a real-time summary for patientsprovidersachieves 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None