Status:
COMPLETED
The Stony Brook University Calm-Mom Study
Lead Sponsor:
Stony Brook University
Collaborating Sponsors:
Massachusetts General Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Pregnancy Related
Stress, Psychological
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The present trial will evaluate the feasibility, acceptability and preliminary efficacy of 2 different internet-delivered programs for prenatal maternal stress. The Stress Managment and Resiliency Tra...
Detailed Description
Aim 1: The investigators will conduct a randomized clinical trial (RCT; n=60) to assess the feasibility, acceptability and preliminary efficacy of the Stress Management and Resillency Training program...
Eligibility Criteria
Inclusion
- \<21 weeks pregnant with medically confirmed viability
- Speak, read and write in English fluently,
- Endorse elevated levels of prenatal maternal stress (PNMS; i.e., New Prenatal Distress Questionnaire Score \> 19).
Exclusion
- Current enrollment in individual or group psychotherapy
- Current un-managed serious mental illness including bipolar disorder and psychosis
- History of previous suicide attempt
- Inappropriate for participation in group therapy format as determined by study director
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT04018625
Start Date
April 1 2021
End Date
June 1 2023
Last Update
August 1 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stony Brook University, Department of Psychiatry
Stony Brook, New York, United States, 11794