Cognitive Behavioral Skills App for Perinatal Mood Management

Recruiting in Palo Alto (17 mi)

Overseen by Andrea Temkin-Yu, Psy.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Substance use disorder, Bipolar, Psychosis, others

No Placebo Group

Approved in 1 Jurisdiction

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.

Trial 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 (Behavioral Intervention)

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.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Dr. Robert Min

Weill Medical College of Cornell University

Chief Executive Officer since 2024

MD, MBA

Dr. Adam R. Stracher

Weill Medical College of Cornell University

Chief Medical Officer since 2024

MD

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]

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]