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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2030-03-29

Brief Summary

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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.

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Detailed Description

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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 depression, gestational diabetes, low birth weight). The mechanism linking trauma exposure and poor perinatal outcomes is elevated anxiety, stress, and low mood during pregnancy. Thus, treatments designed to target these symptoms among trauma-exposed pregnant Veterans are critical. The Veterans Health Administration (VHA) has started to address this need, but the available treatments are not sufficient because they do not address two common symptoms of trauma exposure (i.e., anxiety and stress) or mental health symptoms during pregnancy. Further, pregnant Veterans with a trauma history report myriad barriers to engaging in mental health treatment (e.g., stigma, accessibility, and availability). Calm Moms-V is a treatment program that directly addresses the gaps in care and barriers to treatment for this vulnerable population. Calm Moms-V is an online treatment program rooted in empirically supported cognitive behavioral therapy (CBT) techniques shown to be effective in reducing anxiety and stress and improving mood. Calm Moms-V was adapted from the original Calm Moms program (based on Veteran stakeholder feedback) and now includes four weekly sessions and a booster session close to delivery/postpartum. The current study will build on this work by examining the resulting Calm Moms-V among pregnant Veterans.

Significance: Although a small proportion of the Veteran population, pregnant Veterans are especially vulnerable because they (1) have often recently transitioned from Active Duty, (2) carry a heavy burden of trauma and mental health symptoms, (3) often have partners still on Active Duty, and (4) face fragmented care because obstetrics services must be provided by community providers. Calm Moms-V is an accessible, low-cost, and evidence-based treatment program. Pregnant Veterans who engage in Calm Moms-V may (1) experience a reduction in anxiety, stress, and low mood during pregnancy, (2) have improved functioning and reduced impairment during pregnancy, and (3) show interest and engagement with VHA mental health care.

Innovation/Impact: Trauma-exposed pregnant Veterans have low mental health engagement and report a disinterest in traditional trauma-focused treatment; however, they have among the worst perinatal outcomes, in part due to elevated mental health symptoms. Calm Moms-V will directly address these gaps by providing a program that may reduce anxiety, stress, and low mood symptoms and enhance engagement in mental health treatment.

Specific Aims: The current study aims to: (1) Collect feedback on Veteran experience with Calm Moms-V and make final refinements, (2) Conduct a pilot acceptability and feasibility trial of Calm Moms-V at SLVHCS, and (3) Examine barriers and facilitators to implementation of Calm Moms-V at additional sites.

Methodology: The current study will utilize a mixed-methods approach targeting pregnant Veterans and key VHA stakeholders.

Next Steps/Implementation: This research has the long-term potential to make trauma-informed mental health care readily available for all pregnant Veterans. Although the implementation and dissemination implications of Calm Moms-V are nascent, Calm Moms-V may be useful in a stepped-care framework or as a way to connect pregnant Veterans with additional mental health care. Data from this study will be used to inform additional research aimed at examining the broad implementation of Calm Moms-V in VHA. Further, in collaboration with the study partners, the investigators will work to disseminate results from this study and treatment materials through various local and national outlets.

Conditions

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Trauma-related Mental Health Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

N/A - masking not used.

Study Groups

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Active

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

Group Type EXPERIMENTAL

Calm Moms-V

Intervention Type 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.

Control

The control condition will be care as usual in VHA.

Group Type ACTIVE_COMPARATOR

Care As Usual

Intervention Type 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.

Interventions

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Calm Moms-V

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.

Intervention Type BEHAVIORAL

Care As Usual

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No