Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456307
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-07
Brief Title:
Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics
Sponsor:
Kenyatta National Hospital
Organization:
Kenyatta National Hospital
Study Overview
Official Title:
Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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:
IPMH
Brief Summary:
Perinatal mood and anxiety disorders PMAD defined as depression and anxiety during pregnancy or up to 1 year postpartum account for substantial morbidity and mortality among birthing people globally especially in low- and middle-income countries Several evidence-based interventions are recommended for identification and management of PMAD by non-specialist providers in resource-limited settings This cluster-randomized trial seeks to evaluate the effect of a stepped-care intervention for screening and treatment of PMAD among perinatal women on clinical and implementation outcomes
Detailed Description:
Globally perinatal mood and anxiety disorders PMAD impacts 10-20 of perinatal women with a pooled prevalence of depression at 119 and anxiety at 152 Most of these cases go undetected and untreated since worldwide under 30 of those requiring mental health services have access to them The Kenya Mental Health Action Plan 2021-2025 highlights a goal of expanding access to mental health services including in Maternal and Child Health clinics In Kenya over 95 of all pregnant women receive at least one antenatal care service from a skilled provider However mental health screening is not currently standardized in antenatal and postnatal care visits in Kenya representing a missed opportunity to offer mental health services to those with PMAD symptoms
Several evidence-based interventions are recommended by the WHO for identification and management of PMAD by non-specialist providers in resource-limited settings However their implementation in routine care in Kenya is currently limited due to lack of provider training and comfort with perinatal mental health treatments and poor linkage across cadres of providers such as primary care providers and mental health providers Sustainable integration of perinatal mental healthcare in Kenyas routine perinatal services requires development and testing of tailored interventions that strengthen workforce capacity and facilitate linkage across provider cadres as well as implementation strategies to facilitate high-quality intervention delivery The investigators have identified three EBIs to promote perinatal mental health universal WHO Mental Health Gap Action Programme mhGAP-recommended mental health screening the Problem Management Plus PM counseling intervention for women experiencing PMAD and telepsychiatry for women with severe symptoms suicidality or no response to PM The investigators propose to combine these interventions in a stepped care model named the Integrated Perinatal Mental Health program IPMH and develop implementation strategies to support the models integration into routine perinatal care in Kenya The investigators will then evaluate IPMHs effectiveness and implementation outcomes in a Hybrid Type II trial The study will be conducted in clinics in Kisumu Siaya and Homa Bay counties of Western Kenya Kenya
Broad objective This study seeks to evaluate the effectiveness and implementation outcomes of Integrated Perinatal Mental Health Program IPMH that consists of universal mental health screening problem management plus counseling intervention and telepsychiatry in a Hybrid Type II trial
Aim 1 Using participatory design optimize and adapt IPMH and develop implementation strategies
Aim 2 Determine the effect of IPMH and implementation strategies on mental health HIV care and pregnancy outcomes among perinatal women from pregnancy to 6 months postpartum
Aim 3 Determine effect of IPMH and its implementation strategies on service delivery and implementation outcomes and identify multilevel drivers of successful implementation
Several evidence-based interventions are recommended by the WHO for identification and management of PMAD by non-specialist providers in resource-limited settings However their implementation in routine care in Kenya is currently limited due to lack of provider training and comfort with perinatal mental health treatments and poor linkage across cadres of providers such as primary care providers and mental health providers Sustainable integration of perinatal mental healthcare in Kenyas routine perinatal services requires development and testing of tailored interventions that strengthen workforce capacity and facilitate linkage across provider cadres as well as implementation strategies to facilitate high-quality intervention delivery The investigators have identified three EBIs to promote perinatal mental health universal WHO Mental Health Gap Action Programme mhGAP-recommended mental health screening the Problem Management Plus PM counseling intervention for women experiencing PMAD and telepsychiatry for women with severe symptoms suicidality or no response to PM The investigators propose to combine these interventions in a stepped care model named the Integrated Perinatal Mental Health program IPMH and develop implementation strategies to support the models integration into routine perinatal care in Kenya The investigators will then evaluate IPMHs effectiveness and implementation outcomes in a Hybrid Type II trial The study will be conducted in clinics in Kisumu Siaya and Homa Bay counties of Western Kenya Kenya
Broad objective This study seeks to evaluate the effectiveness and implementation outcomes of Integrated Perinatal Mental Health Program IPMH that consists of universal mental health screening problem management plus counseling intervention and telepsychiatry in a Hybrid Type II trial
Aim 1 Using participatory design optimize and adapt IPMH and develop implementation strategies
Aim 2 Determine the effect of IPMH and implementation strategies on mental health HIV care and pregnancy outcomes among perinatal women from pregnancy to 6 months postpartum
Aim 3 Determine effect of IPMH and its implementation strategies on service delivery and implementation outcomes and identify multilevel drivers of successful implementation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH133266 | NIH | University of Washington | httpsreporternihgovquickSearchR01MH133266 |
| STUDY00017933 | OTHER | None | None |