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

Not Applicable

Not yet recruiting

• Conditions: Post Traumatic Stress Disorder PTSD; Opioid Use Disorder; Intimate Partner Violence (IPV)

• Registration Number: NCT07115030
• Lead Sponsor: Yale University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Study Start: 2025-09-01
• Primary Completion: 2029-08-31
• Study Completion: 2029-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 532

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Retention in MOUD treatment	Week 26	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).

Secondary Outcome Measures

Name	Time	Method
PTSD-related impairment in psychosocial functioning	Week 26	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.
Opioid use disorder symptom severity	Week 26	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.
Days of extra-medical opioid use, past 30 days	Week 26	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.
Urine test positive for opioid use	Week 26	Urine toxicology testing will be performed to assess for the presence of extra-medical opioid use (e.g., opiates, oxycodone, fentanyl).
Depression symptom severity	Week 26	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.
Recovery	Week 26	The 21-item Substance Use Recovery Evaluator (SURE) will be collected to measure substance use recovery. The SURE uses a continuous total recovery score between 21 and 63, with higher scores indicating "higher recovery scores."
Empowerment	Week 26	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.

Trial Locations

Locations (3)

Liberation Programs; 🇺🇸 Bridgeport, Connecticut, United States

Community Health Resources (CHR) Pathways Opiate Treatment Program; 🇺🇸 Enfield, Connecticut, United States

The APT Foundation, Inc.; 🇺🇸 West Haven, Connecticut, United States