RecruitingNot ApplicableNCT07115030

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

Sponsor

Yale University

Enrollment

532 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Post Traumatic Stress Disorder (PTSD)Opioid-use Disorder Intimate Partner Violence (IPV)

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria10

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 Criteria5

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

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Interventions

BEHAVIORALPCT+2HOPE

Each PCT+ group follows the same structure and starts with the group setting an agenda. Clients identify issues to work on using these steps: 1) Identify an issue and if/how it relates to their PTSD or substance use, 2) Brainstorm ideas that may help, 3) Evaluate how useful each idea is, and 4) Choose a plan. Clients are encouraged to implement and evaluate the effectiveness of the plan and share the outcome at their next group. At the end of the group, clients process their experiences of the discussion. HOPE is a flexible, module-based individual treatment where the ordering and emphasis of each module are determined by client priorities. HOPE is trauma-focused; clients relate their current symptoms to their experience of IPV, but do not process traumatic memories. Modules focus on 1) Establishing safety, providing information and skills that enhance empowerment, 2) Cognitive behavioral therapy skills, and 3) Improving relationships and establishing healthy boundaries.