Systematic review of the Exploration, Preparation, Implementation, Sustainment (EPIS) framework.
Joanna C Moullin, Kelsey S Dickson, Nicole A Stadnick...
https://pubmed.ncbi.nlm.nih.gov/30611302Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID07115030
Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery
Led by Yale University · Updated on 2026-06-03
532
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new stepped care model called PCT+2HOPE compared to usual treatment to improve retention in medication for opioid use disorder (MOUD) among women who have experienced intimate partner violence (IPV). The study focuses on women with PTSD-related impairment and opioid use disorder, examining how these treatments affect retention in MOUD and secondary outcomes including trauma symptoms, depression, opioid use, recovery, and empowerment. The study also explores how access to basic needs may influence treatment effectiveness and includes a process evaluation focused on implementation. Participants assigned to the PCT+2HOPE group first attend eight 1-hour group sessions over 12 weeks using Present-Centered Therapy (PCT+) to address daily problems linked to PTSD-related impairment. After 12 weeks, those not retained in MOUD or showing moderate or higher PTSD-related impairment receive a "step up" to HOPE, which consists of 10 individual 1-hour sessions over 14 weeks focused on trauma-related empowerment and cognitive behavioral therapy skills. Participants also receive referrals to community resources and domestic violence services. The comparison group receives treatment as usual. During the study, participants will be monitored for retention in MOUD treatment at 26 weeks, along with assessments of PTSD-related psychosocial functioning, opioid use disorder symptoms, extra-medical opioid use, urine opioid tests, depression, recovery, and empowerment. Participants must be available for group sessions and able to understand English. The study involves random assignment without masking and is sponsored by Yale University, with the trial expected to run until August 2029.
CONDITIONS
Brief Title
Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Woman
- At least 18 years old
- Currently receiving medication for opioid use disorder (MOUD) treatment at a participating site
- Have been on MOUD for more than 14 days for initial stabilization
- Started the current treatment episode within the past 12 months
- Experienced physical or psychological intimate partner violence (IPV) at any time
- Have at least moderate impairment in daily functioning due to PTSD symptoms
- Available during scheduled intervention group times
- Able to read and understand English
- Provide written informed consent
You will not qualify if you...
- Unable to pass a capacity-to-consent questionnaire
- Having an unstable medical condition or unstable psychiatric illness that interferes with participation
- Expect to be unavailable for more than 4 consecutive weeks during the study
- Unable to read or understand English
- Unable to provide at least one form of contact information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - Up to 26 weeks
Participants receive PCT+ through eight 1-hour group sessions over 12 weeks to address PTSD-related impairment in psychosocial functioning. Those who meet criteria after 12 weeks are stepped up to HOPE, an individual counseling program providing 10 one-hour sessions over the next 14 weeks.
Eight 1-hour group sessions over 12 weeks, then up to 10 individual 1-hour sessions over 14 weeks depending on participant progress
Trial Site Locations
Total: 3 locations
1
Liberation Programs
Bridgeport, Connecticut, United States, 06610
Actively Recruiting
2
Community Health Resources (CHR) Pathways Opiate Treatment Program
Enfield, Connecticut, United States, 06082
Not Yet Recruiting
3
The APT Foundation, Inc.
West Haven, Connecticut, United States, 06516
Not Yet Recruiting
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Research Team
T
Tami Sullivan, PhD
A
Ashley Clayton, MA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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