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

NCT06906185 | Recruiting

• 2 other identifiers: CDX 25-002IK2HX003681-01A2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma-related Mental Health Symptoms

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Acceptability of Intervention Measure (AIM)

  The Acceptability of Intervention Measure (AIM) is a brief self-report measures designed to assess the extent to which an intervention is acceptable. Scores range from 8 to 40 with higher scores indicating greater acceptability (better outcome = high acceptability). The AIM is psychometrically sound and have been validated in previous research. The AIM will be administered to Veterans randomized to Calm Moms-V during the one-month and three-month follow-up assessments.

  Aim 2 at one-month follow-up and at three-month follow-up.

• Feasibility of Intervention Measure (FIM)

  The Feasibility of Intervention Measure (FIM) is a brief self-report measures designed to assess the extent to which an intervention is feasible. Scores range from 8 to 40 with higher scores indicating greater feasibility (better outcome = high feasibility). The FIM is psychometrically sound and has been validated in previous research. The FIM will be administered to Veterans randomized to Calm Moms-V during the one-month and three-month follow-up assessments.

  Aim 2 at one-month follow-up and at three-month follow-up.

Secondary Outcomes (1)

• Work and Social Adjustment Scale (WSAS)

  Aim 2 at all assessment timepoints (baseline, one-month follow-up, two-month follow-up, and three-month follow-up).

Other Outcomes (2)

• Generalized Anxiety Disorder-7 (GAD-7)

  Aim 2 at all assessment timepoints (baseline, one-month follow-up, two-month follow-up, and three-month follow-up).

• Patient Health Questionnaire-9 (PHQ-9)

  Aim 2 at all assessment timepoints (baseline, one-month follow-up, two-month follow-up, and three-month follow-up).

Study Arms (2)

Active

EXPERIMENTAL

The active condition will be the Calm Moms-V treatment.

Behavioral: Calm Moms-V

Control

ACTIVE COMPARATOR

The control condition will be care as usual in VHA.

Behavioral: Care As Usual

Interventions

Calm Moms-V BEHAVIORAL

Calm Moms-V is the trauma-informed treatment developed and refined by the PI and being tested in the current study. Calm Moms-V is an online treatment program for trauma-exposed pregnant Veterans designed to target anxiety, stress, low mood, and trauma-related symptoms using empirically supported CBT techniques. Calm Moms-V includes four sessions and a booster session closer to delivery/postpartum. Sessions 1-4 are designed to be completed across four weeks (one session delivered each week). Each session is self-paced and designed to take approximately 45 minutes to complete.

Active

Care As Usual BEHAVIORAL

The control condition will be Care As Usual (CAU). CAU at SLVHCS involves participation in available services chosen by the patient with input from their providers. Further, for all pregnant Veterans that use VHA maternity benefits, CAU includes routine phone calls (throughout pregnancy and up to one-year postpartum) conducted by the site MCC to coordinate maternity benefits, facilitate additional services, and arrange for specific supplies (e.g., breast pump). Further, the SLVHCS MCC mails each pregnant Veteran enrolled in VHA a "welcome packet" that includes national, local, and VHA MH and physical health resources that may be useful to them during the perinatal period. Veterans in the CAU condition will be assessed at the same intervals as those in the active condition.

Control

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Southeast Louisiana Veterans Health Care System, New Orleans, LA

New Orleans, Louisiana, 70119, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Mary E Shapiro, PhD MS

  Southeast Louisiana Veterans Health Care System, New Orleans, LA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary E Shapiro, PhD MS

CONTACT

(504) 507-2000; mary.shapiro1@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: N/A - masking not used.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: During Aim 2, Veterans are randomly assigned (1:1 using a random number generated table) to the active (Calm Moms-V) or control (care as usual in VHA) condition. Aim 1 and Aim 3 do not involve a clinical trial or randomization.

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 2, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): September 29, 2028
• Study Completion (Estimated): March 29, 2030
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)