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

Conditions

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

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PCT+2HOPE — BEHAVIORAL
  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.

Study Details

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.

Key Dates

Start date

Jun 1, 2026

Status verified

Jun 2026

Primary completion

Aug 31, 2029

Completion

Aug 31, 2029

Study Design

Enrollment

532 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: PCT+2HOPE
  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.
• No Intervention: Treatment as Usual
  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.

Primary Outcome Measure

Retention in MOUD treatment [ Time Frame: Week 26 ]

Central Contacts

• Tami Sullivan, PhD
  203-789-7645
  [email protected]
• Ashley Clayton, MA
  203-789-7645 ext 121
  [email protected]

Locations (3)

Find similar trials in Bridgeport, CT

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