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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Arkansas

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to write, understand, and speak English

Able to give informed consent

Currently pregnant or postpartum (≤ 6 months after childbirth)

History of substance misuse

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Written Exposure Therapy (WET)

    Behavioral

    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.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Single Arm InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From baseline to end of treatment at 5 weeks
2

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.

Time frame
From baseline to end of treatment at 5 weeks
3

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.

Time frame
From enrollment to end of treatment at 5 weeks
4

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.

Time frame
From enrollment to end of treatment at 5 weeks

Secondary outcomes

1

PTSD Symptoms

Changes 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.

Time frame
From enrollment to the end of treatment at 5 weeks
2

Depression Symptoms

Depression 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

Time frame
From enrollment to end of treatment at 5 weeks
3

Pre/Postnatal Depression Symptoms

The 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.

Time frame
From enrollment to the end of treatment at 5 weeks
4

Substance Use Severity

The 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.

Time frame
From enrollment to end of treatment at 5 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.