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NCT Number: NCT07759882

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

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.

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Key information

Conditions

Written Exposure Therapy Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Acceptability

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

    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.

  2. Acceptability

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

    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.

  3. Feasibility of Recruitment

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

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

  4. Therapy Adherence

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

    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.

Secondary outcomes

  1. PTSD Symptoms

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

    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.

  2. Depression Symptoms

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

    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

  3. Pre/Postnatal Depression Symptoms

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

    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.

  4. Substance Use Severity

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chelsey E Bull, PhD

CONTACT

[email protected]

Mollee K. Steely Smith K Assistant Professor, PhD

CONTACT

[email protected]

501-526-8174

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Acronym: STRONG Moms

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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