Cognitive Behavioral Skills App for Perinatal Mood Management

Overseen By Ace Oh, MA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Substance use disorder, Bipolar, Psychosis, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app called the Maya Perinatal Cognitive Behavioral Skills App, which offers cognitive behavioral therapy skills to help manage mood, anxiety, and stress during and after pregnancy. The researchers aim to determine if users find the app easy to use and effective in improving mood and reducing anxiety. Participants will use the app for six weeks and provide feedback on their experience. Those who are currently pregnant or have given birth within the past year and struggle with mood or anxiety may be suitable for this trial, provided they have a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance mental health support for new and expecting mothers.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your healthcare provider.

What prior data suggests that this app is safe for perinatal mood management?

Research has shown that the Maya Perinatal Cognitive Behavioral Skills App is designed to help manage mood and anxiety during and after pregnancy. The app uses proven methods to support mental health. No side effects or safety issues have been reported with its use. As a digital tool, it is generally considered safe because it doesn't involve medication or physical treatments. Users have found it helpful in managing mood and anxiety, indicating it is well-received and accepted. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for perinatal mood disorders involve therapy sessions, medication, or a combination of both. However, the Maya Perinatal Cognitive Behavioral Skills App stands out because it offers a digital, accessible approach to managing mood. This app is designed to empower users by delivering cognitive behavioral techniques directly to their phones, making it convenient and user-friendly. Researchers are excited because this app has the potential to provide timely support to new and expecting mothers, who may find it difficult to schedule traditional therapy sessions. Additionally, the app's flexibility might lead to increased adherence and consistency in practicing mood management skills.

What evidence suggests that the Maya App is effective for managing perinatal mood?

Research has shown that cognitive behavioral therapy (CBT) helps manage mood and anxiety. In this trial, participants will use the Maya Perinatal Cognitive Behavioral Skills App, which employs these proven CBT methods to assist pregnant and new mothers. Early results suggest that app-based programs like this can boost mood and reduce anxiety. The app teaches skills to handle stress and mood changes, common during and after pregnancy. Studies have found that similar mobile apps effectively support mental health during this period. ^{1 2 3 4 6}

Who Is on the Research Team?

Andrea Temkin-Yu, Psy.D.

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for pregnant or postpartum individuals up to 12 months after giving birth, who are at least 18 years old and proficient in English. Participants must have access to a smartphone and be able to engage via phone or video calls. Those with recent suicidal thoughts, substance use disorders, or a history of bipolar/psychotic disorders cannot join.

Inclusion Criteria

Currently pregnant or up to 12 months postpartum

Be available to speak by phone or secure video-conference platform at points throughout the study.

English proficiency

Exclusion Criteria

Safety concerns at the time of enrollment, including, but not limited to, a response >0 on the EPDS question 10 or reported suicidal or self-harm thoughts or behaviors within one year of enrollment

Current substance use disorder

I have a history of bipolar or psychotic disorders, or I am currently experiencing symptoms of psychosis or mania.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Maya Perinatal Cognitive Behavioral Skills App for 6 weeks to learn evidence-based strategies for managing mood and anxiety.

6 weeks

3 feedback interviews (phone or video call)

Follow-up

Participants are monitored for app engagement and symptom changes, with feedback collected at 12 weeks.

6 weeks

1 follow-up interview (phone or video call)

What Are the Treatments Tested in This Trial?

Interventions

• Maya Perinatal Cognitive Behavioral Skills App

Trial Overview The study tests the Maya Perinatal Cognitive Behavioral Skills App designed for managing mood and anxiety during pregnancy/postpartum. It includes a series of 12 modules teaching strategies to handle stress, with user feedback collected through questionnaires and interviews.

How Is the Trial Designed?

Group I: Maya Perinatal Cognitive Behavioral Skills App Experimental Treatment 1 Intervention

Participants receive the Maya Perinatal Cognitive Behavioral Skills App for 6 weeks.

Maya Perinatal Cognitive Behavioral Skills App is already approved in United States for the following indications:

Approved in United States as Maya App for:

• Anxiety disorders
• Mood disorders
• Stress management during pregnancy and postpartum

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

Mobile application-based interventions have been found to be feasible and promising in improving parental well-being during the perinatal period, particularly in enhancing parenting self-efficacy, anxiety, and depression, based on a review of 12 studies involving various intervention types.

The review suggests that incorporating educational resources, psychotherapy, and peer support into these mobile interventions can further benefit parents, although more research is needed to assess the long-term effects and to include a more diverse participant population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mobile application-based perinatal interventions in improving parenting outcomes: A systematic review. Chua, JYX., Shorey, S.[2022]

The BEAM app-based program is being tested in a randomized controlled trial with 140 mothers experiencing moderate-to-severe depression and/or anxiety, aiming to reduce maternal depression symptoms and improve overall family functioning over a 10-week intervention period.

This study addresses the urgent need for accessible mental health support for mothers during the COVID-19 pandemic, with the potential to enhance maternal and child health outcomes in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building Emotional Awareness and Mental Health (BEAM): study protocol for a phase III randomized controlled trial of the BEAM app-based program for mothers of children 18-36 months. Xie, EB., Simpson, KM., Reynolds, KA., et al.[2022]

Cognitive Behavioral Therapy (CBT) is effective in reducing perinatal maternal depression, anxiety, and stress, with significant improvements observed both immediately after treatment and in the long term, based on a meta-analysis of 79 studies.

CBT alone showed strong short-term effects for perinatal anxiety and stress, and long-term benefits for depression and anxiety, indicating its versatility and effectiveness across different treatment modalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive behavioral therapy for perinatal maternal depression, anxiety and stress: A systematic review and meta-analysis of randomized controlled trials. Li, X., Laplante, DP., Paquin, V., et al.[2022]

A pilot study involving 30 pregnant individuals and their partners showed that an online cognitive behavioral therapy intervention (the Mothers and Babies Online Course) can significantly reduce anxiety symptoms in pregnant participants compared to a control group.

While both groups experienced reductions in depression and anxiety scores, the study highlighted the need for improved adherence strategies, as partners required more reminders to engage with the program, indicating that including partners in such interventions could enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of an online mental health intervention for pregnant women and their partners: a mixed method study with a pilot randomized control trial. Canfield, SM., Canada, KE., Rolbiecki, AJ., et al.[2023]

A pilot study involving 10 women showed that a 6-week cognitive-behavioral group treatment (CBGT) program significantly reduced anxiety and depressive symptoms related to perinatal anxiety, with all results being statistically significant (p < 0.05).

Participants reported high levels of acceptability and satisfaction with the CBGT program, suggesting it is a promising intervention for addressing anxiety and depression during the perinatal period, although further research with larger groups is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral group treatment for perinatal anxiety: a pilot study. Green, SM., Haber, E., Frey, BN., et al.[2018]

Cognitive Behavioral Therapy (CBT) is highly effective in treating perinatal depression, showing a strong effect size of -0.74 based on a systematic review of 56 studies involving 9,722 participants.

CBT can be delivered in various formats (individual, group, electronic) and by both specialists and nonspecialists, indicating its versatility; however, longer interventions do not necessarily lead to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing cognitive and behavioral approaches for perinatal depression: A systematic review and meta-regression analysis. Waqas, A., Zafar, SW., Akhtar, P., et al.[2023]

Research on mobile apps for women with perinatal mood disorders shows a significant disconnect between academic studies and commercially available apps, with most academic interventions lacking presence in app stores and vice versa.

The review highlights the need for improved collaboration between academia and industry to enhance the quality and effectiveness of mHealth interventions for perinatal mental health, along with proposed practice guidelines for better implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of mHealth application interventions for peripartum mood disorders: trends and evidence in academia and industry. Feldman, N., Back, D., Boland, R., et al.[2021]

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]

The Mothers and Babies (MB) course is a promising cognitive-behavioral intervention aimed at reducing depressive symptoms in low-income women at high risk for perinatal depression, with evidence supporting its efficacy.

The intervention materials are available in both English and Spanish and can be adapted for various settings and formats, indicating potential for broad dissemination and effectiveness in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Perinatal Depression in High Risk Women: Moving the Mothers and Babies Course from Clinical Trials to Community Implementation. Le, HN., Perry, DF., Mendelson, T., et al.[2021]

Cognitive Behavioral Therapy (CBT) significantly reduces depressive symptoms in perinatal populations, with evidence from 40 controlled trials showing its effectiveness in both treating and preventing depression during pregnancy and the first year postpartum.

Interventions started during the postpartum period were more effective than those initiated during pregnancy, and individually-administered CBT treatments outperformed group interventions, particularly among nonwhite, single, and multiparous participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the efficacy of cognitive behavioral therapy for treating and preventing perinatal depression. Sockol, LE.[2018]

The mood tracking and alert (MTA) mobile app significantly increased mental health care contacts for pregnant women with depressive symptoms, leading to better management of their health compared to those using a standard patient portal app.

Women using the MTA app were more likely to receive referrals to mental health specialists, highlighting its effectiveness in improving service delivery and patient engagement in a high-risk obstetric population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Application for Monitoring and Management of Depressed Mood in a Vulnerable Pregnant Population. Hantsoo, L., Criniti, S., Khan, A., et al.[2019]

Citations

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Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

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Feasibility of a Mobile App–Based Cognitive-Behavioral ... Maya-Perinatal Skills Program (M-PSP) uses evidence-based strategies to help individuals manage their mood and anxiety symptoms during pregnancy ...

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Feasibility of a Mobile App-Based Cognitive-Behavioral ... METHODS: This single-arm trial will recruit 50 pregnant or postpartum individuals with mild-to-moderate anxiety or mood symptoms. Participants ...

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Feasibility and Acceptability of a Novel Cognitive ... This study aims to assess the feasibility and acceptability of the Maya Perinatal Cognitive Behavioral Skills App, a novel app for pregnant and postpartum ...

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Cognitive Behavioral Skills App for Perinatal Mood ... What is the purpose of this trial? This trial tests a new mobile app designed to help pregnant and postpartum individuals manage mood, anxiety, and stress. The ...