An interventional study of PCT+2HOPE in Opioid Use Disorder, Intimate Partner Violence (IPV) and Post Traumatic Stress Disorder PTSD, sponsored by Yale University. Recruiting at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 532 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During the first 12 weeks, participants will be offered PCT+ via eight 1-hour group sessions facilitated by a trained counselor ("facilitator") at the treatment program where they receive MOUD. The purpose of this group is to help participants address problems in their daily lives that arise from PTSD-related impairment in psychosocial functioning. After 12 weeks, participants who meet any of the following criteria will be "stepped up" to HOPE: 1) are not retained in MOUD treatment or 2) have moderate or higher impairment in PTSD-related psychosocial functioning. Participants who are "stepped up" will be offered 10 1-hour individual sessions over the next 14 weeks. HOPE is an individual counseling program designed for women in treatment for their opioid use, who have experienced abuse from an intimate partner and are experiencing PTSD-related impairment in psychosocial functioning.
Behavioral: PCT+2HOPE
Participants will be provided with a list of community resources and a referral to a local domestic violence service provider that can help address experiences of relationship strain with an intimate or romantic partner.
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.
Retention 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
Plan to share: Yes — De-identified study data and associated documentation will be made available to the research community free of charge through the Inter-university Consortium for Political and Social Research (ICPSR), which has been approved as a HEAL-compliant data repository.
Time frame: Final submission and release of the study data will occur before the end of the award period. Study data deposited with ICPSR will be available to the research community in perpetuity. Datasets underlying methodological publications will be shared at or prior to initial publication date.
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