Text Messaging Intervention for Perinatal Depression

(PTMI Trial)

Overseen By Katarzyna Pasciak, BS

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Major depressive episode, Panic disorder, Substance use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a text messaging program designed to help prevent depression in pregnant individuals. It aims to determine if supportive texts and helpful videos can reduce the risk of major depression during or after pregnancy. Participants will receive either messages with links to mental health strategies or educational texts about pregnancy and health. This trial is ideal for English-speaking pregnant individuals who have experienced depression before, feel they lack social support, and are comfortable using a smartphone for communication. As an unphased trial, it offers a unique opportunity to contribute to innovative mental health support strategies for pregnant individuals.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this text messaging intervention is safe for perinatal individuals?

Research has shown that using text messages for mental health support is generally safe and well-received. Studies have found that these programs can effectively reduce depression symptoms without causing harm. For instance, the Mothers and Babies Course demonstrated positive effects on mental health.

Similar text-based programs have reported no serious side effects. They are usually easy to use and accessible, encouraging continued participation. This is especially beneficial for new or expecting parents with busy schedules.

Text messaging programs offer helpful information and support conveniently, making them a safe choice for managing depression during and after pregnancy. It is always advisable to consult a healthcare provider about any new treatment, especially for mental health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Text Messaging Intervention for perinatal depression because it offers a novel approach using technology to provide mental health support. Unlike traditional treatments like psychotherapy or medication, this intervention delivers supportive content and therapy-related information through text messages, making it easily accessible for new and expectant mothers. This method not only provides flexibility and convenience but also helps in reaching a broader audience who may face barriers in accessing traditional mental health care. By using video links and text messages focused on Interpersonal Psychotherapy (IPT), it aims to engage users in a familiar and non-intrusive way, potentially enhancing adherence and outcomes.

What evidence suggests that this text messaging intervention is effective for perinatal depression?

Research has shown that text messaging can effectively support mental health, particularly for new and expecting mothers. In this trial, participants in the "Text4Moms" arm will receive text messages with video links that reinforce information relevant to Interpersonal Psychotherapy (IPT), which focuses on improving relationships to boost mental health. One study found that digital tools like text messages helped reduce depression symptoms in pregnant women and new mothers. Another study demonstrated that text message support significantly lowered the risk of postpartum depression, which affects many new mothers. These interventions are effective because they are easy to access and provide timely support and information. ^{1 2 3 6 7}

Who Is on the Research Team?

Kimberly Yonkers, MD

Principal Investigator

UMass Chan Medical School

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals at least 16 years old who are pregnant and at risk of depression, as indicated by certain screening scores or a history of depression during pregnancy. Participants must be willing to use a smartphone for text messages but not currently in mental health treatment, living in an institution, planning on terminating the pregnancy, or suffering from panic or substance use disorders.

Inclusion Criteria

I am at risk of postpartum depression based on my depression history or survey scores.

English speaking

I am 16 years old or older.

Exclusion Criteria

You have been diagnosed with panic disorder or substance use disorder.

Currently in behavioral health care treatment

Permanently living in an institutional setting

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (virtual)

Treatment

Participants receive tailored text messages with links to enhanced content and access to a peer chat function

8 weeks

Continuous virtual engagement

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Text Messaging Intervention

Trial Overview The study is testing a text messaging system designed to lower the risk of major depressive episodes in perinatal individuals. It includes tailored texts with links to resources based on Interpersonal Therapy and offers a peer chat feature. The goal is to see if this intervention can help prevent worsening symptoms of depression.

How Is the Trial Designed?

Group I: Text4Moms Experimental Treatment 1 Intervention

Texts will include video links that reinforce information relevant to Interpersonal Psychotherapy (IPT).

Group II: Educational Control Active Control 1 Intervention

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.

Text Messaging Intervention is already approved in United States, Canada for the following indications:

Approved in United States as Text Messaging Intervention for:

• Perinatal Depression Risk Reduction

Approved in Canada as Text Messaging Intervention for:

• Perinatal Depression Risk Reduction

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Michigan State University

Collaborator

Trials

202

Recruited

687,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Worcester Polytechnic Institute

Collaborator

Trials

19

Recruited

30,000+

Published Research Related to This Trial

A pilot study involving 120 pregnant women in Uganda showed that a mobile health messaging app significantly improved attendance at antenatal care visits and skilled deliveries, with 100% of women in the social supporter group attending at least 4 visits.

The app was highly accepted and deemed useful by over 90% of participants, indicating that leveraging social support networks through tailored messaging can effectively promote maternity service use in rural settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Feasibility, Acceptability, and Preliminary Efficacy of SupportMoms-Uganda, an mHealth-Based Patient-Centered Social Support Intervention to Improve the Use of Maternity Services Among Pregnant Women in Rural Southwestern Uganda: Randomized Controlled Trial. Atukunda, EC., Siedner, MJ., Obua, C., et al.[2023]

A study involving 20 Hispanic adolescents identified key preferences for SMS-based health promotion messages aimed at reducing underage drinking, focusing on aspects like scheduling, frequency, and content.

Teens showed a strong interest in messages that provided knowledge about alcohol, boosted self-efficacy, and offered social support, highlighting the importance of tailoring SMS interventions to the target audience's needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an SMS Intervention for the Prevention of Underage Drinking: Results From Focus Groups. Hospital, MM., Wagner, EF., Morris, SL., et al.[2021]

Text4baby is a pioneering free text messaging service in the U.S. designed to provide essential health information to pregnant women and new mothers, successfully enrolling over 320,000 participants from its launch in 2010 to March 2012.

The rapid enrollment and widespread promotion of Text4baby highlight the effectiveness of public-private partnerships in improving maternal and infant health through accessible communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text4baby: development and implementation of a national text messaging health information service. Whittaker, R., Matoff-Stepp, S., Meehan, J., et al.[2021]

Nurse-led telephone support significantly improved infant feeding practices and tummy time, with higher odds of introducing solid foods at the right time and encouraging early tummy time compared to the control group.

Both telephone and SMS support effectively reduced screen time and bottle use at bedtime, with telephone support showing greater overall benefits in infant care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Telephone and Short Message Service Support on Infant Feeding Practices, "Tummy Time," and Screen Time at 6 and 12 Months of Child Age: A 3-Group Randomized Clinical Trial. Wen, LM., Rissel, C., Xu, H., et al.[2021]

A cluster randomized trial involving 13,937 pregnant women in Hunan, China, tested a maternal education program delivered via text messaging, but the results showed no statistically significant differences in maternal and perinatal mortality rates between the intervention and control groups.

While the intervention arm had slightly lower rates of maternal (0.04% vs. 0.09%) and perinatal deaths (1.24% vs. 1.45%), the study suggests that larger trials with more intensive implementation are needed to confirm any potential benefits of SMS-based maternal education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of a Maternal Education Program Through Text Messaging in Rural China: Cluster Randomized Controlled Trial. Xie, RH., Tan, H., Taljaard, M., et al.[2020]

The Text4baby program significantly improved pregnant women's beliefs about the importance of taking prenatal vitamins and visiting healthcare providers, with odds ratios indicating a strong positive effect on these attitudes.

Despite the positive changes in beliefs, the study did not find any significant behavioral changes among participants, suggesting that while Text4baby influences health attitudes, further research is needed to assess its impact on actual health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial outcomes from a 4-week follow-up study of the Text4baby program in the military women's population: randomized controlled trial. Evans, WD., Wallace Bihm, J., Szekely, D., et al.[2022]

Parents of overweight and obese children generally find text messaging a promising and acceptable method to support healthy behavior changes, preferring it over traditional communication methods like paper or email.

The study revealed that parents would appreciate receiving text messages 2-3 times a week, especially if the messages are endorsed by their child's doctor and include personalized, actionable strategies for behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging text messaging and mobile technology to support pediatric obesity-related behavior change: a qualitative study using parent focus groups and interviews. Sharifi, M., Dryden, EM., Horan, CM., et al.[2021]

Text messaging (SMS) is a highly effective and personal way to deliver behavioral health interventions remotely, leveraging the widespread use of cell phones globally.

Current studies indicate that SMS interventions can successfully promote healthy behaviors and may be more effective than other computerized methods, highlighting the need for future research to optimize SMS features for individual user engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Message Behavioral Interventions: From Here to Where? Suffoletto, B.[2022]

Text messaging is a feasible and acceptable method for communication within a perinatal Collaborative Care program, enhancing access to mental health support for women with perinatal depression.

In this study involving 25 women, care managers initiated most messages, primarily for appointment reminders, while patients valued the ability to ask questions about obstetric and parenting information, indicating a positive engagement with the text messaging system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text messaging to support a perinatal collaborative care model for depression: A multi-methods inquiry. Bhat, A., Mao, J., Unützer, J., et al.[2022]

In a study of 572 pregnant women in Kenya, 32.9% screened positive for elevated depressive symptoms, with factors like interpersonal abuse, lower education, and unemployment being strong predictors.

Antenatal depression was linked to a higher risk of infant illness or hospitalization, and women with depressive symptoms engaged less in SMS communication, indicating a need for targeted support in mHealth interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perinatal depression and its impact on infant outcomes and maternal-nurse SMS communication in a cohort of Kenyan women. Hummel, AD., Ronen, K., Bhat, A., et al.[2023]

The study demonstrated that using smartphones for mood screening and supportive text messages is technically feasible for pregnant and postpartum women, with 67% completing the electronic mood screen.

Participants with private insurance and those who were married were more likely to complete the screening, highlighting potential socioeconomic barriers to accessing mental health support during the perinatal period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of perinatal mood screening and text messaging on patients' personal smartphones. La Porte, LM., Kim, JJ., Adams, MG., et al.[2020]

A review of 48 studies, including 30 randomized controlled trials, found that text messaging can effectively promote various maternal and infant health behaviors, such as smoking cessation and vaccine uptake.

Interventions that are based on established behavior change theories and use motivational language tend to be more successful, highlighting the importance of thoughtful design in text messaging health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of text messaging for maternal and infant health: a systematic review of the literature. Poorman, E., Gazmararian, J., Parker, RM., et al.[2022]

SMS (text messaging) is a widely accessible communication tool that can be effectively utilized for health-related messaging, particularly in mental health care.

Technology-delivered interventions like SMS can support mental health patients in their treatment and recovery, providing a valuable resource for both patients and clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short message service can be a promising tool for psychiatric patients and clinicians. Vernig, PM., Repique, RJ.[2015]

A 36-week SMS-based maintenance treatment (SMSMT) was implemented after a 12-week cognitive behavioral group treatment for 40 children, showing that children adhered to sending 67% of their expected weekly self-monitoring messages.

While there was a significant reduction in Body Mass Index Standard Deviation Scores (BMI-SDS) during the initial treatment phase, the subsequent reduction during SMSMT was not statistically significant, indicating that further research is needed to confirm the efficacy of SMSMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancement of care through self-monitoring and tailored feedback via text messaging and their use in the treatment of childhood overweight. Bauer, S., de Niet, J., Timman, R., et al.[2018]

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The effectiveness of telemedicine interventions, delivered ... Telemedicine interventions significantly decrease postpartum depression symptoms. Women with no history of mental disorders are satisfied with postnatal ...