Clinical trial NCT04525469: Feasibility Trial of Narrative Exposure Therapy (NET) for Posttraumatic Stress Disorder (PTSD) During Pregnancy
Official title: Feasibility Trial of Narrative Exposure Therapy (NET) for Posttraumatic Stress Disorder (PTSD) During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: PTSD
Post Traumatic Stress Disorder
Perinatal
Pregnancy
Trauma
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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:

* Week 1: Consent and Pre-Intervention Clinical AND NET Session 1 Consent Session/Pre-Intervention Clinical interview

  1. Informed Consent: If patients are interested in participating in this study, they will undergo the informed consent procedure. A trained clinician with experience working with trauma survivors will verbally review the informed consent document.
  2. Interview and Self-Report Measures:
  3. Participation in Treatment while enrolled in the study: Patients may be in or seek psychological or psychiatric treatment and still enroll in the study, as long as they are not undergoing exposure therapy. If patients indicate that they are already or wish to seek such treatment, they will be asked to provide consent for study personnel to contact their mental health provider to obtain this single piece of information, as well as whether or not they are being prescribed anti-psychotics (which is a reason for study exclusion)
* NET Session 1

  1. For each weekly session, the content of each session will be taken from the NET manual, a developed manualized treatment. The NET manual can be accessed here: https://www.psychologytools.com/category/narrative-exposure-therapy-net/
* Weeks 2-6: Sessions 2-6 of NET

  1. Participants will also complete self-report measures before the beginning of each NET session via REDCap.
* 1 Week Post-treatment: Post-treatment Evaluation
* 1 Month Post-treatment 10: Post-treatment Evaluation
* 1 Month Postpartum: Follow-up Evaluation
* Qualitative Feedback Interview (upon completion of the intervention or early withdrawal from intervention)

Eligibility criteria: Inclusion:

* 18 years of age or older
* Fluent in English
* History of a DSM-V PTSD criterion A trauma at least 3 months prior to current pregnancy (a person has experienced, witnessed, or been confronted with an event or events that involve actual or threatened death or serious injury, or threat of physical integrity to oneself or others)
* A score of 33 or higher on the PTSD Checklist for the DSM-V with Life Events Checklist for DSM-5 and Criterion A.

Exclusion:

* Current manic or psychotic symptoms or primary psychotic diagnosis
* Serious cognitive impairment
* Concurrent psychotherapy
* Unstable dose of psychotropic medications (must be stable for 6 weeks)
* Serious medical complications of pregnancy (e.g., pre-eclampsia, HELLP syndrome, diagnosed fetal anomaly or death, threatened preterm birth, hospitalization for hypertensive disorders of pregnancy, unstable diabetes, premature rupture of membranes, preterm labor)
* Significant suicidal ideation
* Current legal actions related to trauma
* Patient will be 27 gestational weeks or more at the time of the eligibility session

Primary outcomes:
measure: Feasibility via recruitment rate
timeFrame: Screening to enrollment (Week 1)
measure: Feasibility via retention rate (sessions completed/dropout rate)
timeFrame: Week 1 (NET Session 1) to Week 6 (NET Session 6)
measure: Feasibility via retention rate (completion of follow-up questionnaires)
timeFrame: 1 Week Post-treatment (Post-treatment Evaluation), 1 Month Post-treatment (Post-treatment Evaluation), 1 Month Post-partum (Follow-up Evaluation)
measure: Acceptability of the NET intervention via participant satisfaction
timeFrame: 1 Week Post-treatment (Post-treatment evaluation)
measure: Acceptability of the NET intervention via participant expectancy
timeFrame: Week 1 (NET Session 1) , Week 2, Week 3, Week 4, Week 5, Week 6 (NET Sessions 6)
measure: Acceptability of the NET intervention via perceived benefit
timeFrame: 1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation)
measure: Acceptability of the NET intervention via qualitative feedback
timeFrame: Upon study completion (up to 10 months) or upon early withdrawal from intervention
measure: Change in Symptoms of PTSD
timeFrame: 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)
Secondary outcomes:
measure: Change in Symptoms of Perinatal Depression
timeFrame: 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)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
citation: Stevens NR, Miller ML, Soibatian C, Otwell C, Rufa AK, Meyer DJ, Shalowitz MU. Exposure therapy for PTSD during pregnancy: a feasibility, acceptability, and case series study of Narrative Exposure Therapy (NET). BMC Psychol. 2020 Dec 9;8(1):130. doi: 10.1186/s40359-020-00503-4.