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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
532
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.
Liberation Programs
Bridgeport, Connecticut, United States
RECRUITINGCommunity Health Resources (CHR) Pathways Opiate Treatment Program
Enfield, Connecticut, United States
NOT_YET_RECRUITINGThe APT Foundation, Inc.
West Haven, Connecticut, United States
RECRUITINGRetention in MOUD treatment
Retention in MOUD treatment at week 26. This will be measured through a combination of self-report with objective confirmation (e.g., via electronic health record, provider-confirmed treatment engagement/retention, medication bottles, urine toxicology testing).
Time frame: Week 26
PTSD-related impairment in psychosocial functioning
The Brief-Inventory of Psychosocial Functioning (B-IPF) will be collected to assess PTSD-related impairment in functioning. The PCL-5 will be administered immediately prior and B-IPF items will be anchored to endorsed PTSD). B-IPF total scores represent an index of overall functional impairment, with higher scores indicating greater functional impairment.
Time frame: Week 26
Opioid use disorder symptom severity
Past 30-day opioid use disorder (OUD) symptom severity will be assessed with the Opioid Use Disorder Checklist, an 11-item assessment of DSM-5 criteria. DSM-5 considers 2 to 3 criteria mild; 4 to 5, moderate; and 6 to 11, severe OUD.
Time frame: Week 26
Days of extra-medical opioid use, past 30 days
Past 30-day opioid use will be assessed with the timeline follow back (TLFB) method to capture the number of days of extra-medical opioid use.
Time frame: Week 26
Urine test positive for opioid use
Urine toxicology testing will be performed to assess for the presence of extra-medical opioid use (e.g., opiates, oxycodone, fentanyl).
Time frame: Week 26
Depression symptom severity
The 9-item Patient Health Questionnaire (PHQ-9) will be collected to measure the prevalence and severity of the 9 DSM criteria for depression. The PHQ-9 uses a continuous score with higher scores indicating greater depression symptom severity and a 5-point change indicating clinically significant change.
Time frame: Week 26
Recovery
The Response to Addiction Recovery (R2AR) will be collected to measure recovery. The R2AR is a 19-item assessment that measures recovery from a patient-centered perspective.
Time frame: Week 26
Empowerment
The Personal Progress Scale-Revised (PPS-R) will be collected to measure empowerment. The PPS-R uses a continuous score with higher scores indicating higher empowerment.
Time frame: Week 26
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