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

NCT04525469 | Completed

• 1 other identifier: 18111901-IRB01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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).

Conditions

Post Traumatic Stress Disorder

Keywords

PTSD; Post Traumatic Stress Disorder; Perinatal; Pregnancy; Trauma

Outcome Measures

Primary Outcomes (8)

• Feasibility via recruitment rate

  Investigators will compute the number of phone screens conducted, number of eligibility sessions completed, and number of subjects enrolled to obtain participant enrollment rates.

  Screening to enrollment (Week 1)

• Feasibility via retention rate (sessions completed/dropout rate)

  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.

  Week 1 (NET Session 1) to Week 6 (NET Session 6)

• Feasibility via retention rate (completion of follow-up questionnaires)

  Investigators will calculate the mean number of follow-up questionnaires completed.

  1 Week Post-treatment (Post-treatment Evaluation), 1 Month Post-treatment (Post-treatment Evaluation), 1 Month Post-partum (Follow-up Evaluation)

• Acceptability of the NET intervention via participant satisfaction

  Investigators will compute mean ratings of satisfaction (adapted Client Satisfaction Questionnaire).

  1 Week Post-treatment (Post-treatment evaluation)

• Acceptability of the NET intervention via participant expectancy

  Investigators will compute mean ratings of expectancy via feasibility and acceptability questionnaires.

  Week 1 (NET Session 1) , Week 2, Week 3, Week 4, Week 5, Week 6 (NET Sessions 6)

• Acceptability of the NET intervention via perceived benefit

  Investigators will compute mean ratings of perceived benefit via post-treatment evaluations.

  1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation)

• Acceptability of the NET intervention via qualitative feedback

  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.

  Upon study completion (up to 10 months) or upon early withdrawal from intervention

• Change in Symptoms of PTSD

  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.

  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 (1)

• Change in Symptoms of Perinatal Depression

  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)

Study Arms (1)

Narrative Exposure Therapy

EXPERIMENTAL

NET is a fully-manualized evidence-based treatment for PTSD. Participants will receive 6 weekly 60-minute individual sessions of NET.

Behavioral: Narrative Exposure Therapy

Interventions

Narrative Exposure Therapy BEHAVIORAL

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.

Also known as: NET

Narrative Exposure Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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.

  PMID: 33298159 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 25, 2020
• Study Start: February 27, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)