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

Trial Summary

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 app uses cognitive behavioral therapy techniques to teach users helpful skills. The study aims to see if the app is easy to use and effective for this group. Mobile cognitive behavioral therapy (CBT) has been shown to be effective in managing postpartum depression and reducing the occurrence of depression among pregnant and postpartum women.

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 data supports the effectiveness of the treatment Maya Perinatal Cognitive Behavioral Skills App for perinatal mood management?

Research shows that cognitive behavioral therapy (CBT), which is a key component of the Maya App, is effective in reducing symptoms of depression, anxiety, and stress in pregnant and postpartum women. Studies have found that CBT can be delivered effectively in various formats, including electronic apps, making it a promising approach for managing perinatal mood disorders. ^{1 2 3 4 5}

Is the Maya Perinatal Cognitive Behavioral Skills App safe for use in humans?

There is no specific safety data available for the Maya Perinatal Cognitive Behavioral Skills App, but similar mobile health interventions for perinatal mood management have been studied and are generally considered technically feasible and well-received by users. ^{1 3 6 7 8}

How is the Maya Perinatal Cognitive Behavioral Skills App treatment different from other treatments for perinatal mood management?

The Maya App is unique because it uses a mobile application to deliver cognitive behavioral therapy (CBT) skills, making it more accessible and convenient for new and expecting mothers compared to traditional in-person therapy sessions. This app-based approach can help overcome barriers to accessing mental health care, such as time constraints and lack of local resources. ^{3 8 9 10 11}

Research Team

Andrea Temkin-Yu, Psy.D.

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

I am 18 years old or older.

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

Currently pregnant or up to 12 months postpartum

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Optimizing cognitive and behavioral approaches for perinatal depression: A systematic review and meta-regression analysis. [2023]

3. Austria pubmed.ncbi.nlm.nih.gov

A systematic review of mHealth application interventions for peripartum mood disorders: trends and evidence in academia and industry. [2021]

4. United States 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Mobile Application for Monitoring and Management of Depressed Mood in a Vulnerable Pregnant Population. [2019]

6. England 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. [2022]

7. Austria pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral group treatment for perinatal anxiety: a pilot study. [2018]

8. Austria pubmed.ncbi.nlm.nih.gov

Feasibility of perinatal mood screening and text messaging on patients' personal smartphones. [2020]

9. Scotland pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Preventing Perinatal Depression in High Risk Women: Moving the Mothers and Babies Course from Clinical Trials to Community Implementation. [2021]

11. England 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. [2023]