RECRUITING

Feasibility and Acceptability of a Novel Cognitive Behavioral Skills Mobile App for Pregnant and Postpartum Individuals

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Trial Assessing Feasibility and Acceptability of a Novel Cognitive Behavioral Skills Mobile App for a Perinatal Population

Quick Facts

Study Start:2023-09-19
Study Completion:2025-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05897619

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female, Trans-male, non-binary, gender expansive, or gender questioning gestational carriers of pregnancy
  2. * Currently pregnant or up to 12 months postpartum
  3. * 18 years or older
  4. * English proficiency
  5. * Have access to a smartphone or other mobile device capable of receiving Short Message Service (SMS) pushes and complete Qualtrics surveys and App modules
  6. * Be available to speak by phone or secure video-conference platform at points throughout the study.
  1. * 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
  2. * Current substance use disorder
  3. * History of a bipolar or psychotic disorder, or current symptoms of psychosis or mania.

Contacts and Locations

Study Contact

Andrea Temkin-Yu, Psy.D.
CONTACT
‪(640) 203-8301
abt4002@med.cornell.edu
Ace Oh, MA
CONTACT
sao4008@med.cornell.edu

Principal Investigator

Andrea Temkin-Yu, Psy.D.
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medical College
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Andrea Temkin-Yu, Psy.D., PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-19
Study Completion Date2025-05

Study Record Updates

Study Start Date2023-09-19
Study Completion Date2025-05

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Perinatal Anxiety
  • Perinatal Depression