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| ID | Type | Description | Link |
|---|---|---|---|
| R33DA059895 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD-related impairment in psychosocial functioning | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tami Sullivan, PhD | Contact | 203-789-7645 | tami.sullivan@yale.edu | |
| Ashley Clayton, MA | Contact | 203-789-7645 ext 121 | ashley.clayton@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tami Sullivan, PhD | Yale University | Principal Investigator |
| E. Jennifer Edelman, MD, MHS, AAHIVS | Yale University | Principal Investigator |
| Dawn Johnson, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liberation Programs | Recruiting | Bridgeport | Connecticut | 06610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 30611302 | 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. | |
| 36370469 |
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De-identified study data and associated documentation will be made available to the research community free of charge through the Inter-university Consortium for Political and Social Research (ICPSR), which has been approved as a HEAL-compliant data repository.
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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.
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D003130 | Combat Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Week 26 |
| Opioid use disorder symptom severity | 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. | Week 26 |
| Days of extra-medical opioid use, past 30 days | 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. | Week 26 |
| Urine test positive for opioid use | Urine toxicology testing will be performed to assess for the presence of extra-medical opioid use (e.g., opiates, oxycodone, fentanyl). | Week 26 |
| Depression symptom severity | 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. | Week 26 |
| Recovery | 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. | Week 26 |
| Empowerment | 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. | Week 26 |
| The University of Akron |
| Principal Investigator |
| Community Health Resources (CHR) Pathways Opiate Treatment Program | Not yet recruiting | Enfield | Connecticut | 06082 | United States |
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| The APT Foundation, Inc. | Not yet recruiting | West Haven | Connecticut | 06516 | United States |
|
| 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. |
| 32021588 | 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. |
| 27459503 | 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. |
| 34305273 | 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. |
| 17327524 | 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. |
| 31742672 | 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. |
| 28237054 | 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. |
| 34098298 | 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. |
| 30882491 | 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. |
| 30797400 | 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. |
| 31311330 | 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. |
| 19960546 | 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. |
| 24752965 | 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. |
| 28481562 | 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. |
| 26652898 | 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. |
| 22444420 | 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. |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |