A Text Messaging Intervention to Reduce Perinatal Depression Risk

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Text Messaging Intervention to Reduce Perinatal Depression Risk

Conditions
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Major Depressive Episode

Intervention / Treatment
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* Other: Text Messaging Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text4Moms<br>Texts will include video links that reinforce information relevant to Interpersonal Psychotherapy (IPT). | Other: Text Messaging Intervention<br>* A text messaging intervention that includes enhanced content such as tailoring, video links and a chat function<br>|
| No Intervention: Educational Control<br>The control condition will be limited to texts related to pregnancy, nutrition and sleep. We will avoid elements that have behavioral therapeutic effects. Although this condition is meant to constitute time and attention control, we will include material on recognizing depression and links to ways to attain depression treatment and suicide hotline information. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 baseline, 2 weeks, and 4 weeks; for pilot administered at baseline, 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 | 
| 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 | 
| 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 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 | 
| 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 | 
| Patient engagement with chat | Percentage of participants engaging with chat and endorsing 4 out of 5 on its utility. | 0-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of a major depressive episode | Diagnosis of a major depressive episode using the CAT-MH, which is a self-report computerized adaptive test with items for a major depressive episode. 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 | 
| 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 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 | 
| 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 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 |