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

NCT07115030 | Recruiting DMC

• 2 other identifiers: 2000040103R33DA059895
• Study Type: interventional
• Target: 532
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

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

Keywords

opioid use disorder; intimate partner violence; domestic violence

Outcome Measures

Primary Outcomes (1)

• Retention in MOUD treatment

  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).

  Week 26

Secondary Outcomes (7)

• PTSD-related impairment in psychosocial functioning

  Week 26

• Opioid use disorder symptom severity

  Week 26

• Days of extra-medical opioid use, past 30 days

  Week 26

• Urine test positive for opioid use

  Week 26

• Depression symptom severity

  Week 26

Study Arms (2)

PCT+2HOPE

EXPERIMENTAL

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.

Behavioral: PCT+2HOPE

Treatment as Usual

NO INTERVENTION

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.

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.

PCT+2HOPE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• Yale University: lead

Study Sites (3)

Liberation Programs

Bridgeport, Connecticut, 06610, United States

RECRUITING

Community Health Resources (CHR) Pathways Opiate Treatment Program

Enfield, Connecticut, 06082, United States

NOT YET RECRUITING

The APT Foundation, Inc.

West Haven, Connecticut, 06516, United States

NOT YET RECRUITING

Related Publications (18)

• Johnson DM, Zlotnick C, Gonzalez A. Treatment of Post-traumatic Stress Disorder in Survivors of Intimate Partner Violence. Handbook of Interpersonal Violence and Abuse Across the Lifespan: A project of the National Partnership to End Interpersonal Violence Across the Lifespan (NPEIV). 2021:3223-3246.

  BACKGROUND

• Moullin JC, Dickson KS, Stadnick NA, Rabin B, Aarons GA. Systematic review of the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. Implement Sci. 2019 Jan 5;14(1):1. doi: 10.1186/s13012-018-0842-6.

  PMID: 30611302 BACKGROUND

• Morse AK, Sercombe J, Askovic M, Fisher A, Marel C, Chatterton ML, Kay-Lambkin F, Barrett E, Sunderland M, Harvey L, Peach N, Teesson M, Mills KL. Systematic review of the efficacy, effectiveness, and cost-effectiveness of stepped-care interventions for the prevention and treatment of problematic substance use. J Subst Abuse Treat. 2023 Jan;144:108928. doi: 10.1016/j.jsat.2022.108928. Epub 2022 Nov 4.

  PMID: 36370469 BACKGROUND

• Carroll KM, Weiss RD. The Role of Behavioral Interventions in Buprenorphine Maintenance Treatment: A Review. Focus (Am Psychiatr Publ). 2019 Apr;17(2):183-192. doi: 10.1176/appi.focus.17206. Epub 2019 Apr 10.

  PMID: 32021588 BACKGROUND

• Johnson DM, Johnson NL, Perez SK, Palmieri PA, Zlotnick C. Comparison of Adding Treatment of PTSD During and After Shelter Stay to Standard Care in Residents of Battered Women's Shelters: Results of a Randomized Clinical Trial. J Trauma Stress. 2016 Aug;29(4):365-73. doi: 10.1002/jts.22117. Epub 2016 Jul 26.

  PMID: 27459503 BACKGROUND

• Johnson DM, Palmieri PA, Zlotnick C, Johnson NL, Hoffman L, Holmes SC, Ceroni TL. A Randomized Controlled Trial Comparing HOPE Treatment and Present-Centered Therapy in Women Residing in Shelter with PTSD from Intimate Partner Violence. Psychol Women Q. 2020 Dec 1;44(4):539-553. doi: 10.1177/0361684320953120. Epub 2020 Sep 17.

  PMID: 34305273 BACKGROUND

• Schnurr PP, Friedman MJ, Engel CC, Foa EB, Shea MT, Chow BK, Resick PA, Thurston V, Orsillo SM, Haug R, Turner C, Bernardy N. Cognitive behavioral therapy for posttraumatic stress disorder in women: a randomized controlled trial. JAMA. 2007 Feb 28;297(8):820-30. doi: 10.1001/jama.297.8.820.

  PMID: 17327524 BACKGROUND

• Belsher BE, Beech E, Evatt D, Smolenski DJ, Shea MT, Otto JL, Rosen CS, Schnurr PP. Present-centered therapy (PCT) for post-traumatic stress disorder (PTSD) in adults. Cochrane Database Syst Rev. 2019 Nov 18;2019(11):CD012898. doi: 10.1002/14651858.CD012898.pub2.

  PMID: 31742672 BACKGROUND

• Butner JL, Gupta N, Fabian C, Henry S, Shi JM, Tetrault JM. Onsite treatment of HCV infection with direct acting antivirals within an opioid treatment program. J Subst Abuse Treat. 2017 Apr;75:49-53. doi: 10.1016/j.jsat.2016.12.014. Epub 2017 Jan 24.

  PMID: 28237054 BACKGROUND

• Ngo BV, James JR, Blalock KL, Jackson SL, Chew LD, Tsui JI. Hepatitis C treatment outcomes among patients treated in co-located primary care and addiction treatment settings. J Subst Abuse Treat. 2021 Dec;131:108438. doi: 10.1016/j.jsat.2021.108438. Epub 2021 Apr 29.

  PMID: 34098298 BACKGROUND

• Oldfield BJ, Munoz N, McGovern MP, Funaro M, Villanueva M, Tetrault JM, Edelman EJ. Integration of care for HIV and opioid use disorder. AIDS. 2019 Apr 1;33(5):873-884. doi: 10.1097/QAD.0000000000002125.

  PMID: 30882491 BACKGROUND

• Bailey K, Trevillion K, Gilchrist G. What works for whom and why: A narrative systematic review of interventions for reducing post-traumatic stress disorder and problematic substance use among women with experiences of interpersonal violence. J Subst Abuse Treat. 2019 Apr;99:88-103. doi: 10.1016/j.jsat.2018.12.007. Epub 2018 Dec 24.

  PMID: 30797400 BACKGROUND

• Sullivan TP, Armeli S, Tennen H, Weiss NH, Hansen NB. Fluctuations in daily PTSD symptoms are related to proximal alcohol use: a micro-longitudinal study of women victims of intimate partner violence. Am J Drug Alcohol Abuse. 2020;46(1):98-108. doi: 10.1080/00952990.2019.1624765. Epub 2019 Jul 16.

  PMID: 31311330 BACKGROUND

• Sullivan TP, Cavanaugh CE, Buckner JD, Edmondson D. Testing posttraumatic stress as a mediator of physical, sexual, and psychological intimate partner violence and substance problems among women. J Trauma Stress. 2009 Dec;22(6):575-84. doi: 10.1002/jts.20474.

  PMID: 19960546 BACKGROUND

• Hellmuth JC, Jaquier V, Swan SC, Sullivan TP. Elucidating posttraumatic stress symptom profiles and their correlates among women experiencing bidirectional intimate partner violence. J Clin Psychol. 2014 Oct;70(10):1008-21. doi: 10.1002/jclp.22100. Epub 2014 Apr 19.

  PMID: 24752965 BACKGROUND

• Sullivan TP, Weiss NH, Price C, Pugh N, Hansen NB. Strategies for coping with individual PTSD symptoms: Experiences of African American victims of intimate partner violence. Psychol Trauma. 2018 May;10(3):336-344. doi: 10.1037/tra0000283. Epub 2017 May 8.

  PMID: 28481562 BACKGROUND

• Peirce JM, Brooner RK, King VL, Kidorf MS. Effect of traumatic event reexposure and PTSD on substance use disorder treatment response. Drug Alcohol Depend. 2016 Jan 1;158:126-31. doi: 10.1016/j.drugalcdep.2015.11.006. Epub 2015 Nov 21.

  PMID: 26652898 BACKGROUND

• Engstrom M, El-Bassel N, Gilbert L. Childhood sexual abuse characteristics, intimate partner violence exposure, and psychological distress among women in methadone treatment. J Subst Abuse Treat. 2012 Oct;43(3):366-76. doi: 10.1016/j.jsat.2012.01.005. Epub 2012 Mar 22.

  PMID: 22444420 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders; Combat Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Tami Sullivan, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

• E. Jennifer Edelman, MD, MHS, AAHIVS

  Yale University

  PRINCIPAL INVESTIGATOR

• Dawn Johnson, PhD

  The University of Akron

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tami Sullivan, PhD

CONTACT

203-789-7645; tami.sullivan@yale.edu

Ashley Clayton, MA

CONTACT

203-789-7645 ext 121; ashley.clayton@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Final submission and release of the study data will occur before the end of the award period. Study data deposited with ICPSR will be available to the research community in perpetuity. Datasets underlying methodological publications will be shared at or prior to initial publication date.

Locations

US (3)