NCT06906185 Adaptation and Examination of a Trauma-informed Intervention for Pregnant Veterans
| NCT ID | NCT06906185 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Trauma-related Mental Health Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2028-09-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2025-06-30 with a primary completion date of 2028-09-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Veterans with a history of trauma exposure. Its contents are based on empirically supported cognitive behavioral therapy (CBT) techniques shown to be effective in reducing these symptoms. Further, the Calm Moms program is tailored towards the unique concerns of pregnant women and incorporates information on how to cope with and reduce the impact of trauma. Calm Moms may benefit pregnant Veterans by reducing their anxiety, stress, and low mood symptoms. Additionally, pregnant Veterans who engage in Calm Moms may have improved functioning, reduced impairment during pregnancy, and show increased interest and engagement with additional mental health care. The current proposal also aims to collect information regarding implementation of Calm Moms at additional sites, which will allow Calm Moms to impact a larger group of pregnant Veterans.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Mary E Shapiro, PhD MS
PRINCIPAL INVESTIGATOR
Southeast Louisiana Veterans Health Care System, New Orleans, LA
Frequently Asked Questions
Who can join the NCT06906185 clinical trial?
This trial is open to female participants only, studying Trauma-related Mental Health Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06906185 currently recruiting?
Yes, NCT06906185 is actively recruiting participants. Contact the research team at mary.shapiro1@va.gov for enrollment information.
Where is the NCT06906185 trial being conducted?
This trial is being conducted at New Orleans, United States.
Who is sponsoring the NCT06906185 clinical trial?
NCT06906185 is sponsored by VA Office of Research and Development. The principal investigator is Mary E Shapiro, PhD MS at Southeast Louisiana Veterans Health Care System, New Orleans, LA. The trial plans to enroll 36 participants.