Clinical trial NCT06117397: A Text Messaging Intervention to Reduce Perinatal Depression Risk
Official title: A Text Messaging Intervention to Reduce Perinatal Depression Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Episode
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Yale University
name: Michigan State University
name: Worcester Polytechnic Institute
name: National Institute of Mental Health (NIMH)
First posted: 2023-11-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 function.This 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 initiation/duration. 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.

Eligibility criteria: Inclusion Criteria:

* English speaking
* "At risk" as determined by an Edinburgh Postnatal Depression Scale score of at least 9, or an average score \>3 on the 6-item Medical Outcomes Social Support Survey or history of depression in pregnancy or postpartum depression
* At least age 16
* Are willing and able to provide informed consent
* Are willing to use a smart phone to receive texts

Exclusion Criteria:

* In a major depressive episode
* Planning on terminating pregnancy
* Have panic disorder or substance use disorder
* Currently in behavioral health care treatment
* Blind individuals
* Permanently living in an institutional setting

Primary outcomes:
measure: Edinburgh Prenatal Depression Scale
timeFrame: Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
measure: General Self Efficacy Scale
timeFrame: Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
measure: System Usability Scale
timeFrame: Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
measure: Patient engagement with text messages
timeFrame: 0-8 weeks
measure: Patient engagement with chat
timeFrame: 0-8 weeks
Secondary outcomes:
measure: Diagnosis of a major depressive episode
timeFrame: Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
measure: User Engagement Scale
timeFrame: Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
measure: Perlin Mastery Scale
timeFrame: Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
Study officials:
affiliation: UMass Chan Medical School
name: Kimberly Yonkers, MD
role: PRINCIPAL_INVESTIGATOR
References: