NCT04525469: NET

Feasibility Trial of Narrative Exposure Therapy (NET) for Posttraumatic Stress Disorder (PTSD) During Pregnancy

Completed NA Last updated 22 July 2022

What this trial tests

NA trial testing Narrative Exposure Therapy in Post Traumatic Stress Disorder in 29 participants. Completed in 1 May 2022.

Timeline

27 February 2019

Primary endpoint
1 May 2022

1 May 2022

Quick facts

Lead sponsor	Rush University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	27 February 2019
Primary completion	1 May 2022
Estimated completion	1 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Narrative Exposure Therapy

Conditions studied

• Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →

Sponsor

Rush University Medical Center

Who can join

18 and older, any sex, with Post Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Exposure therapy for PTSD during pregnancy: a feasibility, acceptability, and case series study of Narrative Exposure Therapy (NET).
   Stevens NR, Miller ML, Soibatian C, Otwell C, et al · · 2020 · cited 13× · PMID 33298159 · DOI 10.1186/s40359-020-00503-4