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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorYale University

About this trial

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

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • PCT+2HOPE

Treatment groups

532 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yale University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator