NCT07759882

Brief Summary

The goal of this study is to examine the feasibility and acceptability of providing Written Exposure Therapy (WET), a brief, evidence-based therapy for post-traumatic stress disorder (PTSD) via tele-health to pregnant and postpartum individuals receiving services for problematic substance misuse in Arkansas.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

August 15, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

August 3, 2026

Last Update Submit

August 12, 2026

Conditions

Keywords

Post-traumatic Stress DisorderTrauma Focused Therapy

Outcome Measures

Primary Outcomes (4)

  • Acceptability

    Acceptability will be evaluated using the Client Satisfaction Questionnaire (CSQ-8), an 8-item participant-reported satisfaction measure rated on a 4-point Likert scale. Total scores ranging from 8-32, with higher scores indicating greater satisfaction with the therapy.

    From baseline to end of treatment at 5 weeks

  • Acceptability

    Acceptability will also be evaluated using the Acceptability of Intervention (AIM), which is a 4-item self-reported questionnaire on a 5-point Likert scale assessing acceptability of the intervention. Scores are summed and higher scores indicate greater acceptability.

    From baseline to end of treatment at 5 weeks

  • Feasibility of Recruitment

    Feasibility of recruitment will be assessed by the number of individuals who initiated WET versus the total number of individuals enrolled in the study.

    From enrollment to end of treatment at 5 weeks

  • Therapy Adherence

    Therapy adherence will be assessed by WET session attendance and completion. We will measure therapy adherence by the number of individuals who complete ≥ 4 sessions versus the total number of individuals who received ≤ 3 sessions.

    From enrollment to end of treatment at 5 weeks

Secondary Outcomes (4)

  • PTSD Symptoms

    From enrollment to the end of treatment at 5 weeks

  • Depression Symptoms

    From enrollment to end of treatment at 5 weeks

  • Pre/Postnatal Depression Symptoms

    From enrollment to the end of treatment at 5 weeks

  • Substance Use Severity

    From enrollment to end of treatment at 5 weeks

Study Arms (1)

Single Arm Intervention

EXPERIMENTAL

All participants will receive Written Exposure Therapy (WET)

Behavioral: Written Exposure Therapy (WET)

Interventions

Written Exposure Therapy (WET) is a brief, evidence-based therapy for PTSD. Clients receive 5 weekly sessions where they write about a traumatic experience in a safe, structured way for approximately 50 minutes followed by a brief check-in with their therapist. This process helps individuals make sense of the event, reduce emotional distress, and decrease PTSD symptoms over time.

Single Arm Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to write, understand, and speak English
  • Able to give informed consent
  • Currently pregnant or postpartum (≤ 6 months after childbirth)
  • History of substance misuse
  • Receiving services for substance-use related problems
  • Have a history of traumatic event exposure
  • Endorse clinically significant PTSD symptoms (score ≥ 3 on the Primary Care PTSD Screen for DSM-5; PC-PTSD-5)

You may not qualify if:

  • Unwilling to provide consent
  • No history of Criterion A trauma exposure or clinically significant PTSD symptoms
  • No history of substance misuse or currently receiving services for a substance-use related problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Mollee K Steely Smith, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mollee K. Steely Smith K Assistant Professor, PhD

CONTACT

Chelsey E Bull, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 12, 2026

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

August 30, 2027

Last Updated

August 14, 2026

Record last verified: 2026-08

Locations