What is the mechanism of action of this treatment?

Cognitive Behavioral Therapy (CBT) is a common treatment for Postpartum Depression (PPD) that works by helping patients identify and change negative thought patterns and behaviors contributing to their depression. This approach is crucial for PPD patients as it provides practical skills to manage mood and anxiety, which are prevalent during the postpartum period. By focusing on modifying dysfunctional thinking and behavior, CBT directly addresses the cognitive and emotional challenges faced by new mothers, promoting better mental health outcomes. Additionally, CBT's adaptability to various formats, including digital platforms, enhances its accessibility for postpartum individuals.

What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy (CBT) is a common treatment for postpartum depression and is generally well-tolerated with minimal side effects. Some individuals may experience temporary discomfort when confronting distressing thoughts and emotions during therapy sessions. Other common treatments for postpartum depression include antidepressant medications, which can have side effects such as nausea, fatigue, dry mouth, and sexual dysfunction. It is important for patients to discuss potential side effects with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for postpartum depression, including pharmacological options like brexanolone (Zulresso). However, Cognitive Behavioral Therapy (CBT) is a widely recognized non-pharmacological treatment that has shown efficacy in managing postpartum depression. The Maya Perinatal Cognitive Behavioral Skills App is an example of a digital CBT intervention aimed at helping pregnant and postpartum individuals manage mood and anxiety. While specific FDA approvals for digital CBT apps are not mentioned, CBT itself is a well-established, evidence-based approach for treating postpartum depression.

What other types of research exist?

Promising alternatives to the Maya Perinatal Cognitive Behavioral Skills App for postpartum depression include: 1) Digital interventions such as telehealth-based Cognitive Behavioral Therapy (CBT) and internet-delivered therapist-supported self-help programs. 2) Pharmacological treatments like selective serotonin reuptake inhibitors (SSRIs) and other antidepressants. 3) Complementary therapies such as mindfulness-based cognitive therapy, yoga, and acupuncture, which have shown benefits in managing mood and anxiety symptoms.

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Behavioral Intervention

Cognitive Behavioral Skills App for Perinatal Mood Management

N/A

Recruiting

Led By Andrea Temkin-Yu, Psy.D.

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to be completed at midpoint at approximately 3 weeks, post-intervention at approximately 6 weeks, and follow-up and approximately 12 weeks.

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves using an app for mental health support rather than medication, traditional side effects are not expected. However, users may experience emotional discomfort when addressing personal issues related to mood or anxiety.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to be completed at midpoint at approximately 3 weeks, post-intervention at approximately 6 weeks, and follow-up and approximately 12 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to be completed at midpoint at approximately 3 weeks, post-intervention at approximately 6 weeks, and follow-up and approximately 12 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and to be completed at midpoint at approximately 3 weeks, post-intervention at approximately 6 weeks, and follow-up and approximately 12 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Qualitative Feedback of App Feasibility and Acceptability at follow-up

Qualitative Feedback of App Feasibility and Acceptability at midpoint

Qualitative Feedback of App Feasibility and Acceptability at post-intervention

+4 more

Secondary study objectives

Change in depression measures scores from baseline to midpoint as measured by the Patient Health Questionnaire-9 (PHQ-9)

Change in depression measures scores from baseline to post-intervention as measured by the Patient Health Questionnaire-9 (PHQ-9)

Change in depression measures scores from midpoint to post-intervention as measured by the Patient Health Questionnaire-9 (PHQ-9)

+15 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Maya Perinatal Cognitive Behavioral Skills AppExperimental Treatment1 Intervention

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive Behavioral Therapy (CBT) is a common treatment for Postpartum Depression (PPD) that works by helping patients identify and change negative thought patterns and behaviors contributing to their depression. This approach is crucial for PPD patients as it provides practical skills to manage mood and anxiety, which are prevalent during the postpartum period. By focusing on modifying dysfunctional thinking and behavior, CBT directly addresses the cognitive and emotional challenges faced by new mothers, promoting better mental health outcomes. Additionally, CBT's adaptability to various formats, including digital platforms, enhances its accessibility for postpartum individuals.

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Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,077 Previous Clinical Trials

1,320,617 Total Patients Enrolled

4 Trials studying Postpartum Depression

792 Patients Enrolled for Postpartum Depression

Andrea Temkin-Yu, Psy.D.Principal InvestigatorWeill Medical College of Cornell University

Media Library

Maya Perinatal Cognitive Behavioral Skills App (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05897619 — N/A

Postpartum Depression Research Study Groups: Maya Perinatal Cognitive Behavioral Skills App

Postpartum Depression Clinical Trial 2023: Maya Perinatal Cognitive Behavioral Skills App Highlights & Side Effects. Trial Name: NCT05897619 — N/A

Maya Perinatal Cognitive Behavioral Skills App (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05897619 — N/A

~18 spots leftby May 2025

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