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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Liberation Programs
  Bridgeport, Connecticut, United States Recruiting
• The APT Foundation, Inc.
  West Haven, Connecticut, United States Recruiting
• Community Health Resources (CHR) Pathways Opiate Treatment Program
  Enfield, Connecticut, United States Not yet recruiting

Study contacts

• Principal investigator: Tami Sullivan, PhD — Yale University
• Study coordinator: Tami Sullivan, PhD
• Email: tami.sullivan@yale.edu
• Phone: 203-789-7645

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.