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Recruiting
NCT07115030
Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery
Conditions: Opioid Use Disorder, Intimate Partner Violence (IPV), Post Traumatic Stress Disorder PTSD
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 532
Sponsor: Yale University
Location: Liberation Programs Bridgeport Connecticut
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
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
Source: ClinicalTrials.gov (NCT07115030). StuddyBuddy aggregates publicly available trial information.