PTSD (Childbirth-Related), PTSD - Post Traumatic Stress Disorder
Conditions
Keywords
Pregnancy, Postpartum Period, Narrative Exposure Therapy, Post-Traumatic Stress Disorder, Brief interventions
Brief summary
The NEXT Study is a randomized controlled pilot examining the feasibility and acceptability of a revised perinatal PTSD protocol. This study will randomize perinatal participants with PTSD to receive NET (n=45); treatment group) and will be compared to perinatal women randomized to usual care (n=45; comparator group). The overall objective of this project is to determine the most feasible and acceptable protocol for a brief virtual perinatal PTSD intervention.
Interventions
BEHAVIORALNarrative Exposure Therapy (NET)
Narrative Exposure Therapy (NET) is the PTSD intervention for the treatment group.
Sponsors
Indiana University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Study statistician
Intervention model description
Potential participants will be screened to determine eligibility. If interested and eligible, informed consent will be obtained prior to beginning the study. After signing consent, participants will be asked to complete a self-report baseline assessment. After collection of baseline data, participants will be randomized 1:1 to the NET intervention or usual care group. Block randomization will be used with computer-generated randomization lists provided by the study statistician. All participants will be asked to complete self-report assessments at standard intervention assessment time points: Time 1 (0 weeks; baseline) Time 2 (12 weeks; post-intervention) and Time 3 (24 weeks; 3-month follow-up). Qualitative feedback will be gathered at Time 3, after other data collection is complete. Recruitment procedures, eligibility determination, and assessments will be identical for both groups. Study participation will last 24 weeks, starting at Time 1 (Week 0).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * able to read and speak English * diagnosis of probable PTSD as determined by the PTSD Checklist for DSM-5 (PCL-5) * pregnant or postpartum (delivered within 12 weeks) at the time of the eligibility screen
Exclusion criteria
* current severe suicide risk as determined by the Columbia Suicide Severity Rating Scale Screener (C-SSRS) * current psychotic or manic symptoms as determined by the DIAMOND screener and the Mood Disorder Questionnaire for Bipolar Disorder * cognitive impairment * concurrent trauma-focused psychotherapy * medical advice limiting participation in exposure therapy * current legal actions related to trauma * does not meet criteria for PTSD * not pregnant or delivered more than 12 weeks after timing of eligibility screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Tracking | Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline) | The investigators will determine feasibility by enrollment (≥75% of potential participants enroll), treatment adherence (≥80% of treatment group complete 5/6 NET sessions), assessment completion/each time point (≥75% of sample), and study completion (≥75% of sample). |
| Acceptability | Post-intervention time period (12 weeks post-baseline) | The Triple P-Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), \& Feasibility of Intervention Measure (FIM) scales will be used to assess overall acceptability of the NEXT protocol |
| Perinatal NET Protocol Acceptability Questionnaire (PNPAQ) | Post-intervention time period (12 weeks post-baseline) for the NET treatment group | A 20-item study-specific measure used to assess various PNET protocol components as well as 10 exploratory questions on acceptability of potential future protocol elements (e.g., collection biomarkers, in person v. virtual). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist for DSM-5 (PCL-5) | *Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline). *Weekly to biweekly administration across 12 week intervention period | Self-report assessment of PTSD symptoms in response to a traumatic event in past week or past month |
| Edinburgh Postnatal Depression Scale (EPDS) | *Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline). *Weekly to biweekly administration across 12 week intervention period | Self-report assessment of depressive symptoms in the perinatal period, including suicidality. |
| Life Events Checklist (LEC) | Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline) | Used to self-report traumatic events over the lifetime at start of study as well as any new traumas experienced during treatment period. |
| Perinatal Quality of Life | Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline) | Mother-Generated Index (MGI) will be used to assess valued life domains by specifying up to eight areas of their lives which have been affected by being pregnant/ giving birth to a baby, assessing how the participant felt about this area over the previous month, and describing the domains most important to her. |
Countries
United States
Contacts
CONTACTMichelle L. Miller, PhD
CONTACTNeva Brown, BA
PRINCIPAL_INVESTIGATORMichelle L. Miller, PhD
Indiana University
Outcome results
None listed