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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
Study Summary
This trial will test an app to help pregnant & postpartum people manage mood & anxiety, assessing its acceptability & feasibility. It'll also measure symptom reduction with increased use & satisfaction.
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.Check my eligibility
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.See study design
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreTrial 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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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,245 Total Patients Enrolled
3 Trials studying Postpartum Depression
450 Patients Enrolled for Postpartum Depression
Andrea Temkin-Yu, Psy.D.Principal InvestigatorWeill Medical College of Cornell University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am pregnant and identify as female, trans-male, non-binary, or am questioning my gender.I have a history of bipolar or psychotic disorders, or I am currently experiencing symptoms of psychosis or mania.I can receive texts and complete surveys on my smartphone or device.
Research Study Groups:
This trial has the following groups:- Group 1: Maya Perinatal Cognitive Behavioral Skills App
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What goals are researchers hoping to achieve with this experiment?
"The aim of this clinical trial is to assess the User Version of the Mobile Application Rating Scale (uMARS) at post-intervention. Supplementary objectives include tracking Changes in Edinburgh Postnatal Depression Scores from baseline to post-treatment and from midpoint to end, as well as identifying any changes between post-intervention and follow up according to a 0-30 scale which indicates whether depression is not likely (0-7), possible (8 -13), or probable(14+)."
Answered by AI
Are there any open slots available to join this investigation?
"The trial in question, which was last updated on June 1st 2023, is not presently seeking participants. However, as per clinicaltrials.gov there are currently 1193 other medical studies that have active recruitment periods going on right now."
Answered by AI
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