Screening & TReatment fOr Perinatal WomeN With PTSD in Substance Use Care SettinGs in Arkansas (STRONG Moms)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Arkansas
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Acceptability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Single Arm Intervention
All participants will receive Written Exposure Therapy (WET)
Intervention: Written Exposure Therapy (WET) (Behavioral)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- PTSD Symptoms(From enrollment to the end of treatment at 5 weeks)
- Depression Symptoms(From enrollment to end of treatment at 5 weeks)
- Substance Use Severity(From enrollment to end of treatment at 5 weeks)
- Pre/Postnatal Depression Symptoms(From enrollment to the end of treatment at 5 weeks)