Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery

Recruiting now · Not applicable

Conditions studied: Opioid Use Disorder, Intimate Partner Violence (IPV), Post Traumatic Stress Disorder PTSD

In brief

Using a hybrid type 1 effectiveness-implementation approach, this study aims to evaluate the impact of a novel stepped care model ("PCT+2HOPE") versus treatment as usual (TAU) on increasing retention in community-based medication for opioid use disorder (MOUD) treatment among women who have experienced intimate partner violence (W-IPV). PCT+2HOPE includes Present-Centered Therapy (PCT+) with stepped care as indicated by moderate, severe, or extreme PTSD-related impairment in psychosocial functioning to Helping to Overcome PTSD through Empowerment (HOPE), two evidence-based behavioral interventions adapted for women with opioid use disorder (OUD). We will examine the effectiveness of PCT+2HOPE vs. TAU on the primary outcome (i.e., retention in MOUD treatment) and secondary outcomes related to trauma (i.e., PTSD-related impairment in psychosocial functioning and depression), substance use (i.e. OUD symptom severity, extra-medical opioid use \[i.e., use of prescription opioids without a doctor's prescription; in greater amounts, more often, longer than prescribed, or for a reason other than a doctor said they should be used\], and recovery), and empowerment. We will explore the extent to which the effectiveness of PCT+2HOPE vs. treatment as usual differs based on access to basic needs. We will also conduct an implementation-focused process evaluation.

Key facts

Study ID

NCT07115030

Run by

Yale University

People needed

532

Starts

2026-06-01

Expected to finish

2029-08-31

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Woman;
• Are ≥ 18 years old;
• Receive MOUD treatment at one of the participating sites;
• Have received MOUD for >14 days to allow for initial stabilization;
• Have initiated the current treatment episode within the past 12 months;
• Experienced physical or psychological IPV in their lifetime;
• Have at least moderate impairment in psychosocial functioning (on B-IPF) as a result of PTSD symptoms;
• Available during the date/time of the intervention group
• Able to read/understand English; and
• Provide written informed consent.

You may not qualify if…

• Fail a capacity-to-consent questionnaire;
• Have an unstable medical condition (e.g., hospitalization, planned surgery, newly starting chemotherapy, plans for palliative care) and/or unstable psychiatric illness (e.g., untreated psychosis) that would interfere with their ability to participate in study activities;
• Will be unavailable for >4 consecutive weeks during the study period (e.g., anticipated move, planned surgery);
• Are unable to read/understand English;
• Inability to provide at least one form of contact

Where it is running

• Liberation Programs — Bridgeport, Connecticut, United States (enrolling)
• The APT Foundation, Inc. — West Haven, Connecticut, United States (enrolling)
• Community Health Resources (CHR) Pathways Opiate Treatment Program — Enfield, Connecticut, United States

Full record on ClinicalTrials.gov

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