An interventional study of Written Exposure Therapy (WET) in Written Exposure Therapy, sponsored by University of Arkansas. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by University of Arkansas · Not applicable, Interventional, and Treatment
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.
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 80 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →University of Arkansas is the lead sponsor of 399 studies on the registry; 38 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will receive Written Exposure Therapy (WET)
Behavioral: Written Exposure Therapy (WET)
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.
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
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
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
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
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
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
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
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
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Jun 2027, 9 months after the start.
Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 9 months is below that.
Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Sep 2026, on Oct 8, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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