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

Yale University

Status: Not yet enrolling

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

Treatments: Behavioral: PCT+2HOPE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07115030

2000040103

R61DA059895 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 532 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

532 participants in 2 patient groups

PCT+2HOPE

Experimental group

Description:

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.

Treatment:

Behavioral: PCT+2HOPE

Treatment as Usual

No Intervention group

Description:

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.