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NCT07115030NARecruiting

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

Yale University

Start Date

6/1/2026

Completion Date

8/31/2029

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Interventions

BEHAVIORAL

PCT+2HOPE

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Conditions

Opioid Use DisorderIntimate Partner Violence (IPV)Post Traumatic Stress Disorder PTSD

Locations

Liberation Programs

Bridgeport, Connecticut 06610

United States

Community Health Resources (CHR) Pathways Opiate Treatment Program

Enfield, Connecticut 06082

United States

The APT Foundation, Inc.

West Haven, Connecticut 06516

United States