A Text Messaging Intervention to Reduce Perinatal Depression Risk

Major Depressive Episode Clinical Trial

— Perinatal TMI  

Official title:

A Text Messaging Intervention to Reduce Perinatal Depression Risk

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06117397
• Other study ID #: 00000462
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 14, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: University of Massachusetts, Worcester
• Contact: Kimberly Yonkers, MD
• Phone: 2034945055
• Email: kimberly.yonkers[@]umassmemorial.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Major Depressive Episode

Intervention

Other:
• Text Messaging Intervention
A text messaging intervention that includes enhanced content such as tailoring, video links and a chat function

Locations

Country	Name	City	State
United States	UMass Chan Medical School	Worcester	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Michigan State University, Worcester Polytechnic Institute, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edinburgh Prenatal Depression Scale	10-item continuous measure of depression. Self-report that will be administered by computer. Will be administered three times (for pre-pilot administered at screening, 2 weeks, and 4 weeks; for pilot administered at screening, 4 weeks, and 8 weeks). Items are scored 0-3, with a maximum score of 30. Higher scores show increased severity.	Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
Primary	General Self Efficacy Scale	10 item measure of self efficacy. Items are scored 1-4, with scores ranging between 10 and 40. A higher score indicates more self-efficacy. Will be administered three times (for pre-pilot administered at baseline, 2 weeks, and 4 weeks; for pilot administered at baseline, 4 weeks, and 8 weeks).	Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
Primary	System Usability Scale	10 items rated on a 1-5 scale, with scores ranging from 0-100, with a higher score indicating greater acceptability. Will be administered one times (for pre-pilot administered at 4 weeks; for pilot administered at 8 weeks).	Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
Primary	Patient engagement with text messages	Percentage of participants opening >80% of text messages and clicking on >30% of links to enhanced content.	0-8 weeks
Primary	Patient engagement with chat	Percentage of participants engaging with chat and endorsing 4 out of 5 on its utility.	0-8 weeks
Secondary	Diagnosis of a major depressive episode	Diagnosis of a major depressive episode using the PHQ-9, the Major Depressive Disorder module of the full PHQ. Will be administered three times (for pre-pilot administered at screening, 2 weeks, and 4 weeks; for pilot administered at screening, 4 weeks, and 8 weeks).	Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
Secondary	User Engagement Scale	12 items rated on a 1-5 scale, with scores ranging from 10-50, with higher scores indicating greater acceptability, with an average score of 80.3. Will be administered one time (for pre-pilot administered at 4 weeks; for pilot administered at 8 weeks).	Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
Secondary	Perlin Mastery Scale	7 items scaled on a 1-4 scale, with scores ranging from 7-28. Low scores indicate low mastery. Will be administered one time at baseline.	Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline