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Screening & TReatment fOr Perinatal WomeN With PTSD in Substance Use Care SettinGs in Arkansas (STRONG Moms)

Screening & TReatment fOr Perinatal WomeN With PTSD in Substance Use Care SettinGs in Arkansas (STRONG Moms)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07759882
Acronym
STRONG Moms
Enrollment
80
Registered
2026-08-12
Start date
2026-08-15
Completion date
2027-08-30
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Written Exposure Therapy

Keywords

Post-traumatic Stress Disorder, Trauma Focused Therapy

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.

Detailed description

The primary objective is to evaluate the feasibility and acceptability of implementing a brief, telehealth-delivered behavioral intervention for PTSD among pregnant and postpartum individuals with a history of substance misuse. Secondary objectives include estimating the prevalence of probable PTSD in perinatal substance use treatment settings, assessing participant interest in receiving PTSD treatment while engaged in substance use care, and examining preliminary changes in PTSD and depressive symptoms following treatment. The study consists of two sequential components. First, pregnant and postpartum individuals receiving services for problematic substance misuse in Arkansas will be screened for PTSD symptoms using the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5). Screening will be conducted across multiple treatment and care settings, including inpatient and outpatient programs, to estimate the prevalence of probable PTSD and characterize willingness to participate in trauma-focused treatment during the perinatal period. Second, individuals who meet eligibility criteria for PTSD treatment will participate in a mixed-methods, single-arm pre-post pilot evaluation of Written Exposure Therapy (WET), a brief evidence-based behavioral intervention for PTSD delivered via telehealth. Approximately 20 pregnant and postpartum participants with PTSD will receive the intervention. Feasibility will be assessed through measures such as recruitment, enrollment, retention, intervention completion, and assessment completion. Acceptability will be evaluated using participant-reported satisfaction and qualitative interviews exploring experiences with treatment delivery, barriers and facilitators to participation, and recommendations for implementation. Clinical assessments conducted before and after treatment will provide preliminary estimates of changes in PTSD symptoms and depressive symptoms.

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.

Sponsors

University of Arkansas
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
AcceptabilityFrom baseline to end of treatment at 5 weeksAcceptability 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.
Feasibility of RecruitmentFrom enrollment to end of treatment at 5 weeksFeasibility of recruitment will be assessed by the number of individuals who initiated WET versus the total number of individuals enrolled in the study.
Therapy AdherenceFrom enrollment to end of treatment at 5 weeksTherapy 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.

Secondary

MeasureTime frameDescription
PTSD SymptomsFrom enrollment to the end of treatment at 5 weeksChanges in PTSD symptoms will be assessed using the PTSD Checklist for DSM-5 (PCL-5), a 20-item self-report questionnaire on symptoms of PTSD. Scores range from 0-80, with higher scores indicating a greater PTSD symptom severity.
Depression SymptomsFrom enrollment to end of treatment at 5 weeksDepression symptoms will be assessed using the Personal History Questionnaire (PHQ-9), a 9-item questionnaire used to assess depression symptoms over the past 2 weeks. Total scores range from 0-27, with higher scores indicating greater severity of depression symptoms
Pre/Postnatal Depression SymptomsFrom enrollment to the end of treatment at 5 weeksThe Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report questionnaire to assess depressive symptoms experiences during the previous 7 days in pregnant and postpartum individuals, will also be used to assess perinatal postpartum depression. Total scores range from 0-30, with higher scores indicating greater severity of depressive symptoms.
Substance Use SeverityFrom enrollment to end of treatment at 5 weeksThe DSM-5 Drug Use Disorder (DUD) and Alcohol Use Disorder (AUD) Symptom Checklist is a self-report measure to assess the presence of diagnostic criteria for drug use disorders. This measure evaluates the 11 DSM-5 criteria for drug use disorders, including impaired control, social impairment, risky use, and pharmacologic indicators (tolerance/withdrawal). Endorsement of a greater number of criteria indicates greater severity and can be categorized as mild, moderate, or severe.

Countries

United States

Contacts

CONTACTMollee K. Steely Smith K Assistant Professor, PhD
mksteelysmith@uams.edu501-526-8174
CONTACTChelsey E Bull, PhD
cebull@uams.edu
PRINCIPAL_INVESTIGATORMollee K Steely Smith, PhD

University of Arkansas

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026