Status:
RECRUITING
Adaptation and Examination of a Trauma-informed Intervention for Pregnant Veterans
Lead Sponsor:
VA Office of Research and Development
Conditions:
Trauma-related Mental Health Symptoms
Eligibility:
FEMALE
Phase:
NA
Brief Summary
The current proposal aims to refine and examine an intervention called Calm Moms. Calm Moms is a web-based treatment program designed to reduce anxiety, stress, and low mood symptoms among pregnant Ve...
Detailed Description
Background: Trauma exposure and subsequent mental health symptoms are exceptionally common among pregnant Veterans and associated with a variety of negative perinatal outcomes (e.g., postpartum depres...
Eligibility Criteria
Inclusion
- Pregnant (any trimester)
- Endorse a DSM-5-TR Criterion A traumatic event as indexed by the trauma exposure portion of the PTSD screen for primary care (PC-PTSD-5)
- Endorse clinically elevated anxiety (as indexed by a total score of \> 3 on the GAD-2) or depression symptoms (as indexed by a total score of \> 3 on the PHQ-2)
- Able to participate in an online intervention (i.e., have internet and smartphone, tablet, or computer access)
- Of note, pregnant Veterans will still be eligible if they are in concurrent psychotherapy and/or using psychotropic medications.
Exclusion
- Evidence of a significant mental illness that would impede completion of the intervention
- (i.e., active psychosis, uncontrolled bipolar disorder, a severe alcohol/substance use disorder, or suicidal ideation or behavior that requires immediate hospitalization or treatment)
- Evidence of a significant mental illness will be determined via pre-enrollment chart review.
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 29 2030
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06906185
Start Date
June 30 2025
End Date
March 29 2030
Last Update
July 15 2025
Active Locations (1)
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1
Southeast Louisiana Veterans Health Care System, New Orleans, LA
New Orleans, Louisiana, United States, 70119