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Adaptation and Examination of a Trauma-informed Intervention for Pregnant Veterans

RecruitingNAAges any - anyFemaleVA Office of Research and Development
NCT06906185 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Calm Moms-V
  • Care As Usual
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Where

1 site
Southeast Louisiana Veterans Health Care System, New Orleans, LA
New Orleans, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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