Adaptation and Examination of a Trauma-informed Intervention for Pregnant Veterans
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Calm Moms-V
BehavioralCalm 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 Usual
BehavioralThe 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.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: ActiveExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Aim 2 at one-month follow-up and at three-month follow-up.2
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.
Time frame
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.
Time frame
Aim 2 at all assessment timepoints (baseline, one-month follow-up, two-month follow-up, and three-month follow-up).Other outcomes
1
Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) will be used to assess anxiety symptoms over time. Scores range from 0 to 21 with higher scores indicating greater anxiety symptoms (worse outcome = high score or higher anxiety symptoms). The GAD-7 is psychometrically sound and has been validated in previous research. The GAD-7 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 anxiety over time.
Time frame
Aim 2 at all assessment timepoints (baseline, one-month follow-up, two-month follow-up, and three-month follow-up).2
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess depression symptoms over time. Scores range from 0 to 27 with higher scores indicating greater depression symptoms (worse outcome = high score or higher depression symptoms). The PHQ-9 is psychometrically sound and has been validated in previous research. The PHQ-9 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 depression over time.
Time frame
Aim 2 at all assessment timepoints (baseline, one-month follow-up, two-month follow-up, and three-month follow-up).Sponsors and contacts
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Source ClinicalTrials.gov