Rush University Medical Center
Chicago, Illinois, 60612, United States
NCT Number: NCT04525469
Posttraumatic stress disorder (PTSD) affects up to 35% of pregnant trauma survivors. Moreover, prenatal PTSD rates are up to 4 times higher among communities of color compared to white populations. PTSD during pregnancy has been linked to an increased risk of adverse perinatal and infant health outcomes and may even contribute to racial disparities in adverse perinatal outcomes. Although front-line treatments exist for PTSD, treatment research that specifically focus on pregnancy are extremely limited. Clinical studies examining the safety, acceptability, feasibility, and efficacy of treatments for PTSD during pregnancy are virtually non-existent. Thus, pregnant individuals with PTSD, particularly within low-income communities of color, are a vulnerable and underserved group in need of effective treatment approaches for their distress. Investigators propose to conduct a feasibility and acceptability study of a PTSD treatment, Narrative Exposure Therapy (NET), in a sample of pregnant individuals with PTSD in which low-income people of color are highly represented.
Aim 1: The purpose of Aim 1 will be to examine feasibility. Investigators will evaluate the recruitment and assessment procedures.
Aim 2: The purpose of Aim 2 will be to examine acceptability. Investigators will evaluate participant feedback of the NET intervention.
Aim 3: The purpose of Aim 3 will be to examine the proportion of participants demonstrating clinically meaningful reduction in PTSD and perinatal depression symptoms from pre- to post-treatment.
Investigators will aim to enroll up to 30 participants; participation will last up to ten months. Data sources will include questionnaires, electronic medical records, and qualitative feedback interviews.
With this study, investigators aim to fill a critical gap in knowledge of how to safely and effectively treat PTSD among a vulnerable and underserved population (i.e., perinatal individuals of color).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60612, United States
Investigators will conduct a feasibility and acceptability study of Narrative Exposure Therapy (NET) to treat up to 30 pregnant trauma survivors with clinically-significant symptoms of PTSD.
Up to 100 participants will be recruited with the aim of enrolling 30 participants in NET. Pregnant patients will be recruited from Rush OB/GYN resident training clinics. The racial/ethnic composition of patients served at these clinics (>70% ethno-racial minorities) will ensure that participants of color will be highly represented. Methods of recruitment include NET brochures that will be placed in the clinic's waiting rooms, OB/GYN physicians and nurse referring patients with a known history of trauma, and a 2-item screening measure -- the PTSD Checklist, Civilian Version (PCL-2) -- at the patient's initial OB appointment to facilitate recruitment.
Following initial referral, the study team will conduct a brief phone screen to ensure basic eligibility criteria are met, describe the study purpose, and schedule eligible participants for an initial study session (week 0). During the initial visit participants will sign informed consent and complete self-report measures (week 1 of the study) - after which they will then be enrolled in the intervention (weeks 1-6 of the study). Participants will complete post-treatment self-report measures and treatment evaluation measures at 1 week and 1-month following their last NET session (week 7 and week 10, respectively), and again at 1-month postpartum. The participant will also be invited to complete a qualitative feedback interview upon completion of the intervention (or early withdrawal from intervention).
Participants will be compensated for completion of all assessments and study components.
Due to the Coronavirus/COVID-19 pandemic, all study activities will be conducted via telephone or telehealth.
Schedule of Activities:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion:
Exclusion:
NET involves: 1) diagnostic interview and psychoeducation, 2) laying out the Lifeline, 3) NET therapy sessions (constructing the trauma narrative in context of the life course), 4) final session rituals. Laying out the Lifeline (using rope or string) allows participants to take a bird's eye view of the events of their life using simple items such as flowers to represent positive events and stones to represent traumatic events. The focus of NET sessions is to encourage participants to describe the details of traumas and integrating the "cold" memories (i.e., facts) with the "hot" memories (e.g., cognitions, emotions, physiological feelings, and sensory information). The therapist makes notes after each session narrating the details of the traumas ("stones") and reads this at the beginning of each subsequent session. Final session rituals involve re-reading the trauma narrative, hopes for the future, and laying out the final Lifeline placing flowers for hopes and wishes for the future.
Other names: NET
Time frame: Screening to enrollment (Week 1)
Investigators will compute the number of phone screens conducted, number of eligibility sessions completed, and number of subjects enrolled to obtain participant enrollment rates.
Time frame: Week 1 (NET Session 1) to Week 6 (NET Session 6)
Investigators will calculate the mean number of sessions attended and the dropout rate, recording reason for drop out, such as participants' desire to withdraw from the NET treatment vs. medical complications of pregnancy or early delivery.
Time frame: 1 Week Post-treatment (Post-treatment Evaluation), 1 Month Post-treatment (Post-treatment Evaluation), 1 Month Post-partum (Follow-up Evaluation)
Investigators will calculate the mean number of follow-up questionnaires completed.
Time frame: 1 Week Post-treatment (Post-treatment evaluation)
Investigators will compute mean ratings of satisfaction (adapted Client Satisfaction Questionnaire).
Time frame: Week 1 (NET Session 1) , Week 2, Week 3, Week 4, Week 5, Week 6 (NET Sessions 6)
Investigators will compute mean ratings of expectancy via feasibility and acceptability questionnaires.
Time frame: 1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation)
Investigators will compute mean ratings of perceived benefit via post-treatment evaluations.
Time frame: Upon study completion (up to 10 months) or upon early withdrawal from intervention
Primary outcome will include qualitative feedback regarding aspects of the NET intervention and its acceptability during pregnancy and in preparation for the transition to parenthood via a study-developed qualitative interview.
Time frame: Week 1 (NET Session 1), 1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation)
Investigators will use the Posttraumatic Check List for DSM-5 (PCL-5), a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.
Time frame: Week 1 (NET Session 1), 1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation)
Investigators will use the Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report measure for depression screening in the perinatal period.
Rush University Medical Center
Other
Acronym: NET
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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