RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Adaptation and Examination of a Trauma-informed Intervention for Pregnant Veterans (CDA 22-135)

Quick Facts

Study Start:2025-06-30
Study Completion:2030-03-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06906185

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant (any trimester)
  2. * 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)
  3. * 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)
  4. * Able to participate in an online intervention (i.e., have internet and smartphone, tablet, or computer access)
  1. * Evidence of a significant mental illness that would impede completion of the intervention
  2. * (i.e., active psychosis, uncontrolled bipolar disorder, a severe alcohol/substance use disorder, or suicidal ideation or behavior that requires immediate hospitalization or treatment)

Contacts and Locations

Study Contact

Mary E Shapiro, PhD MS
CONTACT
(504) 507-2000
mary.shapiro1@va.gov

Principal Investigator

Mary E Shapiro, PhD MS
PRINCIPAL_INVESTIGATOR
Southeast Louisiana Veterans Health Care System, New Orleans, LA

Study Locations (Sites)

Southeast Louisiana Veterans Health Care System, New Orleans, LA
New Orleans, Louisiana, 70119
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Mary E Shapiro, PhD MS, PRINCIPAL_INVESTIGATOR, Southeast Louisiana Veterans Health Care System, New Orleans, LA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-30
Study Completion Date2030-03-29

Study Record Updates

Study Start Date2025-06-30
Study Completion Date2030-03-29

Terms related to this study

Keywords Provided by Researchers

  • Anxiety
  • Depression
  • PTSD
  • Pregnant Veteran
  • Reproductive Mental Health

Additional Relevant MeSH Terms

  • Trauma-related Mental Health Symptoms