Written Exposure TherapySTRONG MomsNCT07759882
Screening & TReatment fOr Perinatal WomeN With PTSD in Substance Use Care SettinGs in Arkansas (STRONG Moms)
A study testing Written Exposure Therapy (WET) in people with Written Exposure Therapy, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Written Exposure Therapy
- What is being tested?
- Written Exposure Therapy (WET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chelsey E Bull, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Mollee K Steely Smith, PhD, 501-526-8174, mksteelysmith@uams.edu
Chelsey E Bull, PhD, cebull@uams.edu
About this study
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.
Read the 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.
- Conditions
- Written Exposure Therapy
- Being tested
- Written Exposure Therapy (WET)
- Keywords
- Post-traumatic Stress Disorder, Trauma Focused Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Exposure Therapy (WET)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Intervention | Experimental | All participants will receive Written Exposure Therapy (WET) Receives: Behavioral: Written Exposure Therapy (WET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to end of treatment at 5 weeks
Secondary outcomes (4)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: From enrollment to end of treatment at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Sep 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Written Exposure TherapyStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mollee K Steely Smith, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759882
- Sponsor's protocol ID
- 300210
- Acronym
- STRONG Moms
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening & TReatment fOr Perinatal WomeN With PTSD in Substance Use Care SettinGs in Arkansas (STRONG Moms)
- ClinicalTrials.gov ID
- NCT07759882
- Acronym / sponsor ID
- STRONG Moms / 300210
- Conditions
- Written Exposure Therapy
- Keywords
- Post-traumatic Stress Disorder, Trauma Focused Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Intervention | Experimental | Behavioral: Written Exposure Therapy (WET)All participants will receive Written Exposure Therapy (WET) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Single Arm Intervention |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
PTSD Symptoms
Time frame: From enrollment to the end of treatment at 5 weeks
Depression Symptoms
Time frame: From enrollment to end of treatment at 5 weeks
Pre/Postnatal Depression Symptoms
Time frame: From enrollment to the end of treatment at 5 weeks
Substance Use Severity
Time frame: From enrollment to end of treatment at 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chelsey E Bull, PhD contact
Mollee K Steely Smith, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written Exposure Therapy (WET) in people with Written Exposure Therapy, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mollee K. Steely Smith K Assistant Professor, PhD (501-526-8174, mksteelysmith@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: From baseline to end of treatment at 5 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.