Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery
NCT ID: NCT07115030
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
532 participants
INTERVENTIONAL
2026-01-10
2029-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
PCT+2HOPE
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.
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.
No interventions assigned to this group
Interventions
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PCT+2HOPE
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Tami Sullivan, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
E. Jennifer Edelman, MD, MHS, AAHIVS
Role: PRINCIPAL_INVESTIGATOR
Yale University
Dawn Johnson, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Akron
Locations
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Liberation Programs
Bridgeport, Connecticut, United States
Community Health Resources (CHR) Pathways Opiate Treatment Program
Enfield, Connecticut, United States
The APT Foundation, Inc.
West Haven, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2000040103
Identifier Type: -
Identifier Source: org_study_id
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