Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women

NCT ID: NCT04264520

Last Updated: 2024-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-05

Study Completion Date

2021-04-23

Brief Summary

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The current study aims to test a brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms. In this open trial pilot feasibility study, 20 pregnant women in their first trimester will be invited to participate in the study if they endorse elevated PTSD symptoms. Oxytocin and cortisol will be measured at baseline, one month post-intervention, three months post-intervention, and post-delivery to inform the relationship between these hormones, PTSD symptoms, and peripartum/postpartum outcomes. In addition to receiving the psychoeducation + skills intervention during their first trimester, women will be offered a "booster session" intervention following delivery to enhance utilization of skills during a critical period for maternal mental and physical health outcomes.

Detailed Description

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Conditions

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Perinatal Problems Post Traumatic Stress Disorder Post Partum Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open Label Pilot Trial (no control group)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PTSD Psychoeducation + Skills Intervention

Group Type EXPERIMENTAL

PTSD Psychoeducation + Skills Intervention

Intervention Type BEHAVIORAL

A brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms.

Interventions

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PTSD Psychoeducation + Skills Intervention

A brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18-40 years old
* Fluent in English

Exclusion Criteria

* Active and severe domestic violence
* Evidence of a significant mental illness or current substance use disorder that would impede the completion of the intervention
* Suicidal individuals deemed at immediate danger or risk (i.e., requiring immediate hospitalization or treatment)
* Women who smoke
* Women who have a metabolic or endocrine disorder.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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MUSC Specialized Center of Research Excellence

UNKNOWN

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University of South Carolina Institute of Psychiatry

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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00096405

Identifier Type: -

Identifier Source: org_study_id

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