Jennifer E Johnson1, Ted R Miller2, Robert L Stout3, Caron Zlotnick4, Louis A Cerbo5, Joel T Andrade6, Shannon Wiltsey-Stirman7. 1. Division of Public Health, Michigan State University College of Human Medicine, 200 East 1st St Room 332, Flint, MI 48503, United States. Electronic address: Jennifer.Johnson@hc.msu.edu. 2. Pacific Institute of Research and Evaluation, 11720 Beltsville Drive, Suite 900, Calverton, MD 20705, United States. Electronic address: miller@pire.org. 3. Decision Sciences Institute, 1005 Main Street Unit 8120, Pawtucket, RI 02860, United States. Electronic address: Stout@pire.org. 4. Butler Hospital and Brown University, 345 Blackstone Blvd., Providence, RI 02906, United States. Electronic address: Caron_Zlotnick@brown.edu. 5. Rhode Island Department of Corrections, 39 Howard Avenue, Cranston, RI 02920, United States. Electronic address: Louis.Cerbo@doc.ri.gov. 6. MHM Services, Inc., 110 Turnpike Road, Suite 308, Westborough, MA 01581, United States. Electronic address: jandrade@mhm-services.com. 7. National Center for PTSD, Dissemination and Training Division, 795 Willow Road (NC-PTSD 334), Menlo Park, CA 94025, United States. Electronic address: Shannon.Wiltsey-Stirman@va.gov.
Abstract
PURPOSE: This article describes the protocol for a Hybrid Type I cost-effectiveness and implementation study of interpersonal psychotherapy (IPT) for men and women prisoners with major depressive disorder (MDD). The goal is to promote uptake of evidence-based treatments in criminal justice settings by conducting a randomized effectiveness study that collects implementation data, including a full cost-effectiveness analysis. BACKGROUND: More than 2.3 million people are incarcerated in the United States on any given day. MDD is the most common severe mental illness among incarcerated individuals. Despite the prevalence and consequences of MDD among incarcerated populations, this study will be the first fully-powered randomized trial of any treatment for MDD in an incarcerated population. DESIGN: Given the politically charged nature of the justice system, advantageous health outcomes are often not enough to get an intervention implemented in prisons. To increase the policy impact of this trial, we sought advice from prison providers and administrators about outcomes that would be persuasive to policy-makers and defensible to the public. In this trial, effectiveness questions will be answered using a randomized clinical trial design comparing IPT plus prison treatment as usual (TAU) to TAU alone, with outcomes including depressive symptoms (primary), suicidality, and in prison functioning (enrollment and completion of correctional programs; disciplinary and incident reports; aggression/victimization; social support). Implementation outcomes will include cost-effectiveness; feasibility and acceptability of IPT to clients, providers, and administrators; prison provider intervention fidelity, attitudes, and competencies; and barriers and facilitators of implementation assessed through surveys, interviews, and process notes.
RCT Entities:
PURPOSE: This article describes the protocol for a Hybrid Type I cost-effectiveness and implementation study of interpersonal psychotherapy (IPT) for men and women prisoners with major depressive disorder (MDD). The goal is to promote uptake of evidence-based treatments in criminal justice settings by conducting a randomized effectiveness study that collects implementation data, including a full cost-effectiveness analysis. BACKGROUND: More than 2.3 million people are incarcerated in the United States on any given day. MDD is the most common severe mental illness among incarcerated individuals. Despite the prevalence and consequences of MDD among incarcerated populations, this study will be the first fully-powered randomized trial of any treatment for MDD in an incarcerated population. DESIGN: Given the politically charged nature of the justice system, advantageous health outcomes are often not enough to get an intervention implemented in prisons. To increase the policy impact of this trial, we sought advice from prison providers and administrators about outcomes that would be persuasive to policy-makers and defensible to the public. In this trial, effectiveness questions will be answered using a randomized clinical trial design comparing IPT plus prison treatment as usual (TAU) to TAU alone, with outcomes including depressive symptoms (primary), suicidality, and in prison functioning (enrollment and completion of correctional programs; disciplinary and incident reports; aggression/victimization; social support). Implementation outcomes will include cost-effectiveness; feasibility and acceptability of IPT to clients, providers, and administrators; prison provider intervention fidelity, attitudes, and competencies; and barriers and facilitators of implementation assessed through surveys, interviews, and process notes.
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