Recruiting

Cognitive Behavioral Skills

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05897619

Conditions

Perinatal Anxiety

Perinatal Depression

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Experimental: Maya Perinatal Cognitive Behavioral Skills App

Study Details

Brief summary:

This study aims to assess the feasibility and acceptability of the Maya Perinatal Cognitive Behavioral Skills App, a novel app for pregnant and postpartum individuals experiencing difficulties with mood, anxiety, or stress. Participants will complete the 12-module app to learn evidence-based strategies previously shown to help manage mood and anxiety. Assessments will include app feedback questionnaires, feedback interviews, a daily symptom tracker, and symptom measures. The study investigators hypothesizes that participants will find content to be helpful in developing skills to manage anxiety and mood difficulties during the perinatal period, and that the app interface, session structure, and pacing will be acceptable and feasible for this population. It is further hypothesized that increased Maya Perinatal Cognitive Behavioral Skills App use, engagement, and satisfaction will be associated with lower self-reported anxiety and mood symptoms.

Conditions

Perinatal Anxiety

Perinatal Depression

Study ID

NCT05897619

Start date

Sep 19, 2023

Status verified date

Feb, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Female, Trans-male, non-binary, gender expansive, or gender questioning gestational carriers of pregnancy
  • Currently pregnant or up to 12 months postpartum
  • 18 years or older
  • English proficiency
  • Have access to a smartphone or other mobile device capable of receiving Short Message Service (SMS) pushes and complete Qualtrics surveys and App modules
  • Be available to speak by phone or secure video-conference platform at points throughout the study.

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
  • History of a bipolar or psychotic disorder, or current symptoms of psychosis or mania.

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Maya Perinatal Cognitive Behavioral Skills App

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

Interventions

Experimental: Maya Perinatal Cognitive Behavioral Skills App

The intervention includes the completion of a mobile skills app teaching evidence-based strategies tailored for perinatal mood and anxiety. Modules include psychoeducation, skill information, practice exercises, and homework.

Primary outcome measure

  • User Version of the Mobile Application Rating Scale (uMARS) at midpoint [ Time Frame: Midpoint (approximately 3 weeks) ]
  • User Version of the Mobile Application Rating Scale (uMARS) at post-intervention [ Time Frame: Post-intervention (approximately 6 weeks) ]
  • User Version of the Mobile Application Rating Scale (uMARS) at follow-up [ Time Frame: Follow-up (approximately 12 weeks) ]
  • Quantitative Feedback Survey of App Feasibility and Acceptability [ Time Frame: Module 1 (approximately week 1) ]
  • Quantitative Feedback Survey of App Feasibility and Acceptability [ Time Frame: Module 2 (approximately week 1) ]
  • Quantitative Feedback Survey of App Feasibility and Acceptability [ Time Frame: Module 3 (approximately week 2) ]
  • Quantitative Feedback Survey of App Feasibility and Acceptability [ Time Frame: Module 4 (approximately week 2) ]
  • Quantitative Feedback Survey of App Feasibility and Acceptability [ Time Frame: Module 5 (approximately week 3) ]
  • Quantitative Feedback Survey of App Feasibility and Acceptability [ Time Frame: Module 6 (approximately week 3) ]
  • Quantitative Feedback Survey of App Feasibility and Acceptability [ Time Frame: Module 7 (approximately week 4) ]
  • Quantitative Feedback Survey of App Feasibility and Acceptability [ Time Frame: Module 8 (approximately week 4) ]
  • Quantitative Feedback Survey of App Feasibility and Acceptability [ Time Frame: Module 9 (approximately week 5) ]
  • Quantitative Feedback Survey of App Feasibility and Acceptability [ Time Frame: Module 10 (approximately week 5) ]
  • Quantitative Feedback Survey of App Feasibility and Acceptability [ Time Frame: Module 11 (approximately week 6) ]
  • Quantitative Feedback Survey of App Feasibility and Acceptability [ Time Frame: Module 12 (approximately week 6) ]
  • Qualitative Feedback of App Feasibility and Acceptability at midpoint [ Time Frame: Midpoint (approximately 3 weeks) ]
  • Qualitative Feedback of App Feasibility and Acceptability at post-intervention [ Time Frame: Post-intervention (approximately 6 weeks) ]
  • Qualitative Feedback of App Feasibility and Acceptability at follow-up [ Time Frame: Follow-up (approximately 12 weeks) ]

Central Contacts and Locations

Central contacts

Andrea Temkin-Yu, Psy.D.

‪(640) 203-8301abt4002@med.cornell.edu

Gail Harrison, MA

gah4007@med.cornell.edu

Locations

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10065

Contacts

Andrea Temkin-Yu, Psy.D.

640-203-8301abt4002@med.cornell.edu

Gail Harrison, B.S.

gah4007@med.cornell.edu

Principal Investigator:

Andrea Temkin-Yu, Psy.D.

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Perinatal
  • Pregnancy
  • Postpartum
  • Perinatal Mood and Anxiety Disorders
  • Cognitive Behavioral Therapy
  • Mobile App
  • mobile Health (mHealth)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-02-27.