Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06117397
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2023-05-01
Brief Title:
A Text Messaging Intervention to Reduce Perinatal Depression Risk
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
A Text Messaging Intervention to Reduce Perinatal Depression Risk
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:
Perinatal TMI
Brief Summary:
Development and preliminary testing of a text messaging intervention that will reduce the risk of a major depressive episode and worsening depressive symptoms in perinatal individuals The system will screen pregnant individuals send tailored text messages with links to enhanced content and will include a peer chat functionThis accessible text platform will leverage both the ease of use inherent in text messages and the power of enhanced content drawn evidence from based behavioral interventions Interpersonal Therapy
Detailed Description:
About 1 in 7 pregnant individuals experience depression with roughly the same number facing this devastating illness after delivery The downstream effects of perinatal depression adds to its toll with increased risk of preterm birth impairments in maternal-child attachment adverse effects on infant development and decreased breastfeeding initiationduration The US Preventative Services Task Force finds that some major depressive episodes MDEs can be averted with counseling strategies that employ principles from interpersonal therapy IPT They also observe the value of peer support which can decrease perinatal depression A possible shared mechanism for these interventions is enhancement of self-efficacy which is critical in the setting of stressful events such as pregnancy and parenting However practical implementation of interventions to reduce depression risk is challenging Reproductive health providers have limited time and training to deliver depression prevention programs As well perinatal individuals may not appreciate the need to participate in a prevention program or have difficulty finding or affording providers of behavioral interventions Technology can assist with these challenges by providing education support and therapeutic interventions to perinatal individuals Unlike web-based applications apps text messaging interventions TMIs can proactively deliver health information and messages even to those with limited motivation to engage in preventative interventions Mobile phone use has exploded with 95 of pregnant individuals including 85 of the minority population reporting use of a mobile phone to communicate via short text messages TMIs can also screen perinatal individuals for depression outside the general medical setting and provide general peer support With end-user input throughout the process the investigators will build a multi-component TMI called Text4Moms that screens and triages perinatal individuals for risk of a MDE This system will draw content from IPT it will send tailored text messages with links to relevant video content to perinatal individuals at risk for a depressive episode An on-demand secure chat function staffed by a peer with lived experience will complement the text messages for enhanced support The system will include pre-populated content for peers to cut and paste into text messages for participants which will support peers and decrease their training burden This system leverages some of the best components of an app video tailoring chat into a common and user-friendly text messaging platform After development the investigators will conduct a pilot randomized trial to test the ability of the TMI to enhance the target of self-efficacy and decrease depressive symptoms and risk of a MDE The investigators will query Research Domain Criteria RDOC constructs of loss and threat and will evaluate preliminary effectiveness and implementation assessment of feasibility acceptability use and benefit of the peer chat feature through a pilot randomized clinical trial
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