Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365645
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-04-09
Brief Title:
Feasibility Acceptability of App-based Cognitive Behavioral Therapy for Postpartum Depression Prevention
Sponsor:
Women and Infants Hospital of Rhode Island
Organization:
Women and Infants Hospital of Rhode Island
Study Overview
Official Title:
Examining the Feasibility and Acceptability of a Novel App-based Cognitive Behavioral Therapy Intervention for Preventing Postpartum Depression
Status:
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:
None
Brief Summary:
Postpartum depression PPD affects up 10-15 of mothers overall but the rate of PPD can be as high as 25 among mothers with personal or obstetric risk factors The Mothers Babies Program MB is a cognitive behavioral therapy CBT-based program that has been shown to prevent PPD among high-risk mothers without a prior history of depression MB has been so consistently effective that the United States Preventive Services Task Force recommends this program be given to high-risk pregnant patients Originally designed to be given in-person and via groups MB has been adapted to be given in person one-on-one in clinic or at home and via text message However MB has yet to be adapted to a smartphone application app Via evidence-based qualitative research and end-user centered design MB has been adapted to a novel app MBapp This study aims to examine the feasibility and acceptability of MBapp as a study intervention for perinatal patients as well as provide preliminary estimates of effect for the intervention
Detailed Description:
Overall 10-15 of women are diagnosed with postpartum depression PPD Though the most significant risk factor for PPD is a history of depression or prior PPD rates of PPD are as high as 25 among women without prior depression or PPD but with personal risk factors such as reporting little social support or food insecurity during pregnancy and structural factors such as being unmarried There are profound maternal and pediatric consequences of postpartum mental illness untreated PPD is associated with maternal morbidity9-11 and impaired child cognitive development As such the American College of Obstetricians Gynecologists recommends screening all postpartum women for PPD
There are however several structural barriers to the implementation of this recommendation First to be screened for PPD women must attend postpartum visits and 60 of women do so Barriers such as lack of childcare or transportation reduce postpartum visit attendance and disproportionately affect low-income women Second pregnancy-related health insurance ends at 60 days postpartum but PPD can persist for months after delivery leaving low-income women without subsidized access to screening or treatment Third unlike those with known psychiatric illness many pregnant women without prior mental illness do not receive antenatal mental health screening unless via universal screening leading to delayed recognition of and diagnosis of depressive symptoms Tools to overcome these barriers are sorely needed particularly for those with the least access who currently fall through the cracks
Therapy preventing PPD delivered via smartphone applications apps may be such a tool The USPSTF concluded that Cognitive Behavioral Therapy CBT - which teaches coping skills to modify maladaptive conditions behaviors and physiological responses24 25 - reduces rates of PPD by 49 The USPSTF highlighted the Mothers and Babies MB CBT program for reducing rates of PPD by 53 among low-income women of color MB was originally designed as a preventive in-person therapy for low-income English- and Spanish-speaking women without psychiatric illness and contains one parenting education module and multiple CBT modules MB has started to become a digital health intervention online MB has been shown to be feasible and text-message-base MB has been examined in one small study However to our knowledge no studies of app-based MB exist Online or text-message MB may increase access but participation with an app would likely be higher for several reasons Individuals are more likely to have smartphones than internet access 96 of those aged 18-29 years own smartphones Additionally apps provide two advantages compared to other digital health programs 1 App-based content is accessible without cellular or internet service 2 Apps serve as just-in-time adaptive interventions35-37 delivering support tailored to individual behaviors Thus app-based MB may decrease PPD while overcoming barriers to care
Over the last two years this NIH-funded study has utilized evidence-based user-centered digital intervention design techniques and qualitative research methodology to adapt the MB curriculum into a novel smartphone application MBapp Similar to MB MBapp contains one parenting education module and multiple CBT-based modulesWe now propose a pilot randomized control trial to examine the feasibility acceptability and preliminary estimates of effects of the full MB program via MBapp intervention when compared to app-based digital parenting education an attention control group Our long-term goal is to use MBapp to prevent PPD among perinatal women at high-risk for the condition due to those with structural or personal risk factors
There are however several structural barriers to the implementation of this recommendation First to be screened for PPD women must attend postpartum visits and 60 of women do so Barriers such as lack of childcare or transportation reduce postpartum visit attendance and disproportionately affect low-income women Second pregnancy-related health insurance ends at 60 days postpartum but PPD can persist for months after delivery leaving low-income women without subsidized access to screening or treatment Third unlike those with known psychiatric illness many pregnant women without prior mental illness do not receive antenatal mental health screening unless via universal screening leading to delayed recognition of and diagnosis of depressive symptoms Tools to overcome these barriers are sorely needed particularly for those with the least access who currently fall through the cracks
Therapy preventing PPD delivered via smartphone applications apps may be such a tool The USPSTF concluded that Cognitive Behavioral Therapy CBT - which teaches coping skills to modify maladaptive conditions behaviors and physiological responses24 25 - reduces rates of PPD by 49 The USPSTF highlighted the Mothers and Babies MB CBT program for reducing rates of PPD by 53 among low-income women of color MB was originally designed as a preventive in-person therapy for low-income English- and Spanish-speaking women without psychiatric illness and contains one parenting education module and multiple CBT modules MB has started to become a digital health intervention online MB has been shown to be feasible and text-message-base MB has been examined in one small study However to our knowledge no studies of app-based MB exist Online or text-message MB may increase access but participation with an app would likely be higher for several reasons Individuals are more likely to have smartphones than internet access 96 of those aged 18-29 years own smartphones Additionally apps provide two advantages compared to other digital health programs 1 App-based content is accessible without cellular or internet service 2 Apps serve as just-in-time adaptive interventions35-37 delivering support tailored to individual behaviors Thus app-based MB may decrease PPD while overcoming barriers to care
Over the last two years this NIH-funded study has utilized evidence-based user-centered digital intervention design techniques and qualitative research methodology to adapt the MB curriculum into a novel smartphone application MBapp Similar to MB MBapp contains one parenting education module and multiple CBT-based modulesWe now propose a pilot randomized control trial to examine the feasibility acceptability and preliminary estimates of effects of the full MB program via MBapp intervention when compared to app-based digital parenting education an attention control group Our long-term goal is to use MBapp to prevent PPD among perinatal women at high-risk for the condition due to those with structural or personal risk factors
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