Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07115030

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Combat Disorders Intimate Partner Violence (IPV) Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Post Traumatic Stress Disorder PTSD Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Liberation Programs, Bridgeport, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Retention in MOUD treatment

    Time frame: 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 outcomes

  1. PTSD-related impairment in psychosocial functioning

    Time frame: 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.

  2. Opioid use disorder symptom severity

    Time frame: 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.

  3. Days of extra-medical opioid use, past 30 days

    Time frame: 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.

  4. Urine test positive for opioid use

    Time frame: Week 26

    Urine toxicology testing will be performed to assess for the presence of extra-medical opioid use (e.g., opiates, oxycodone, fentanyl).

  5. Depression symptom severity

    Time frame: 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.

  6. Recovery

    Time frame: Week 26

    The Response to Addiction Recovery (R2AR) will be collected to measure recovery. The R2AR is a 19-item assessment that measures recovery from a patient-centered perspective.

  7. Empowerment

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Clayton, MA

CONTACT

[email protected]

203-789-7645 ext 121

Tami Sullivan, PhD

CONTACT

[email protected]

203-789-7645

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: STRONGER

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 11, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.