Stepped care to improve MOUD retention for women with OUD, PTSD, and IPV history

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

This study tests whether a stepped care program combining Present-Centered Therapy and HOPE can help women on medication for opioid use disorder who experienced intimate partner violence stay in treatment longer and reduce PTSD-related problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 532 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Yale University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Bridgeport, Connecticut and 2 other locations)
• Trial ID: NCT07115030 on ClinicalTrials.gov

What this trial studies

Using a hybrid type 1 effectiveness-implementation design, participants are randomized to a novel stepped care model (PCT+2HOPE) or treatment as usual at community-based MOUD clinics. PCT+2HOPE starts with Present-Centered Therapy and steps up to the HOPE intervention for those with moderate to severe PTSD-related psychosocial impairment. The primary outcome is retention in MOUD treatment, and secondary outcomes include PTSD-related impairment, depression, OUD symptom severity, and extra-medical opioid use. Recruitment targets women receiving MOUD who have a lifetime history of intimate partner violence and at least moderate PTSD-related functional impairment.

Who should consider this trial

Good fit: Women aged 18 or older who are receiving MOUD at one of the participating Connecticut clinics, have been on MOUD for more than 14 days and started the current treatment episode within the past 12 months, report lifetime IPV, and have at least moderate PTSD-related psychosocial impairment are ideal candidates.

Not a fit: People who are male, not receiving MOUD at the participating sites, lack PTSD-related impairment, cannot read English, have unstable medical or psychiatric conditions, or will be unavailable for more than four consecutive weeks are unlikely to benefit from this program.

Why it matters

Potential benefit: If successful, the intervention could increase retention in MOUD and reduce PTSD-related impairment and depressive symptoms, improving recovery outcomes for women affected by IPV.

How similar studies have performed: Present-Centered Therapy and HOPE have shown benefit for trauma-related symptoms in IPV-exposed women, but using a stepped care approach specifically to improve MOUD retention is relatively novel and not yet widely tested.

Eligibility criteria

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

Where this trial is running

Bridgeport, Connecticut and 2 other locations

• Liberation Programs — Bridgeport, Connecticut, United States (Recruiting)
• Community Health Resources (CHR) Pathways Opiate Treatment Program — Enfield, Connecticut, United States (Not_yet_recruiting)
• The APT Foundation, Inc. — West Haven, Connecticut, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Tami Sullivan, PhD — Yale University
• Study coordinator: Tami Sullivan, PhD

Conditions Opioid Use Disorder; Intimate Partner Violence; Post Traumatic Stress Disorder PTSD; opioid use disorder; intimate partner violence; domestic violence