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

Locations

3
Liberation Programs06610, BridgeportConnecticut, United States
Community Health Resources (CHR) Pathways Opiate Treatment Program06082, EnfieldConnecticut, United States
The APT Foundation, Inc.06516, West HavenConnecticut, United States

Sponsors and collaborators

Yale University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator