Trauma-related Mental Health SymptomsNCT06906185
Adaptation and Examination of a Trauma-informed Intervention for Pregnant Veterans
A study testing Calm Moms-V and Care As Usual in people with Trauma-related Mental Health Symptoms, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Trauma-related Mental Health Symptoms
- What is being tested?
- Calm Moms-V and Care As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2025to 29 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Southeast Louisiana Veterans Health Care System, New Orleans, LA
New Orleans, Louisiana, 70119
Mary E Shapiro, PhD MS, (504) 507-2000 ext. 67282, mary.shapiro1@va.gov
Mary E Shapiro, PhD MS
About this study
Official title: Adaptation and Examination of a Trauma-informed Intervention for Pregnant Veterans (CDA 22-135)
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.
Read the detailed description
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
- Trauma-related Mental Health Symptoms
- Being tested
- Calm Moms-V, Care As Usual
- Keywords
- Anxiety, Depression, PTSD, Pregnant Veteran, Reproductive Mental Health
- Medical subject headings
- Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calm Moms-VBehavioural
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.
Care As UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | The active condition will be the Calm Moms-V treatment. Receives: Behavioral: Calm Moms-V |
| Control | Active comparator | The control condition will be care as usual in VHA. Receives: Behavioral: Care As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Aim 2 at one-month follow-up and at three-month follow-up.
Secondary outcomes (1)
Work and Social Adjustment Scale (WSAS)
The Work and Social Adjustment Scale (WSAS) will be used to assess functional impairment due to mental health difficulties over time. Scores range from 0 to 40 with higher scores indicating greater functional impairment (worse outcome = high scores or increased functional impairment). The WSAS is psychometrically sound and has been validated in previous research. The WSAS will be administered at all assessment timepoints (baseline, one-month follow-up, two-month follow-up, and three-month follow-up) to examine changes in functioning and impairment over time.
Measured: Aim 2 at all assessment timepoints (baseline, one-month follow-up, two-month follow-up, and three-month follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start30 Jun 2025
- Primary completion29 Sep 2028 (estimated)
- Study completion29 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma-related Mental Health SymptomsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mary E Shapiro, PhD MS, Principal investigator, Southeast Louisiana Veterans Health Care System, New Orleans, LA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906185
- Sponsor's protocol ID
- CDX 25-002
- Other IDs
- IK2HX003681-01A2
- Status last verified
- May 2026
- First submitted
- 18 Mar 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Examination of a Trauma-informed Intervention for Pregnant Veterans (CDA 22-135)
- ClinicalTrials.gov ID
- NCT06906185
- Acronym / sponsor ID
- CDX 25-002
- Conditions
- Trauma-related Mental Health Symptoms
- Keywords
- Anxiety, Depression, PTSD, Pregnant Veteran, Reproductive Mental Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 29 Sep 2028 (estimated)
- Study completion
- 29 Mar 2030 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Behavioral: Calm Moms-VThe active condition will be the Calm Moms-V treatment. |
| Control | Active comparator | Behavioral: Care As UsualThe control condition will be care as usual in VHA. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Evidence of a significant mental illness that would impede completion of the intervention
- Evidence of a significant mental illness will be determined via pre-enrollment chart review.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calm Moms-VCalm 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. | Behavioural | Active |
| Care As UsualThe 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. | Behavioural | Control |
Primary outcome
Acceptability of Intervention Measure (AIM)
Time frame: Aim 2 at one-month follow-up and at three-month follow-up.
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.
Feasibility of Intervention Measure (FIM)
Time frame: Aim 2 at one-month follow-up and at three-month follow-up.
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.
1 secondary outcome
Work and Social Adjustment Scale (WSAS)
Time frame: Aim 2 at all assessment timepoints (baseline, one-month follow-up, two-month follow-up, and three-month follow-up).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary E Shapiro, PhD MS principal investigator
Southeast Louisiana Veterans Health Care System, New Orleans, LA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calm Moms-V and Care As Usual in people with Trauma-related Mental Health Symptoms, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary E Shapiro, PhD MS ((504) 507-2000 ext. 67282, mary.shapiro1@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (AIM) (time frame: Aim 2 at one-month follow-up and at three-month follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.