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Study protocol: Hybrid Type I cost-effectiveness and implementation study of interpersonal psychotherapy (IPT) for men and women prisoners with major depression.

ABSTRACT: 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.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.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.

SUBMITTER: Johnson JE

PROVIDER: S-EPMC4962862 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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Study protocol: Hybrid Type I cost-effectiveness and implementation study of interpersonal psychotherapy (IPT) for men and women prisoners with major depression.

Johnson Jennifer E JE Miller Ted R TR Stout Robert L RL Zlotnick Caron C Cerbo Louis A LA Andrade Joel T JT Wiltsey-Stirman Shannon S

Contemporary clinical trials 20160201

<h4>Purpose</h4>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.<h4>Background</h4>More than 2.3 million people are incarcerated i ...[more]

PMID: 26845030

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Project description:BACKGROUND:Psychological distress, defined as depression, anxiety and perceived stress, during pregnancy is common, with 15-25% of women experiencing clinically significant levels of such distress. Despite the far-reaching impact of prenatal psychological distress on mothers and their children, and that women are receptive to screening, few providers routinely screen for prenatal psychological distress and less than one in five women will receive the mental health care that they require. There is a lack of certainty regarding the most effective treatments for prenatal psychological distress. No online interpersonal psychotherapy (IPT) trials have been conducted that focus on improving psychological distress in prenatal women. The purpose of this pilot randomized controlled trial is to evaluate the perspectives of pregnant women on the feasibility and acceptability of online IPT (e-IPT) delivered during pregnancy. METHODS:A pilot randomized controlled trial design with repeated measures will evaluate the feasibility and acceptability of e-IPT for pregnant women compared to routine prenatal care. Qualitative interviews with 15-30 individuals in the intervention group will provide further data on the feasibility and acceptability of the intervention. Assessment of feasibility will include the ease of accessing and completing the intervention. Women will also be asked about what barriers there were to starting and completing the e-IPT. Assessment of acceptability will inquire about the perception of women regarding the intervention and its various features. A sample size of 160 consenting pregnant women aged 18 years and older will be enrolled and randomized into the experimental (e-IPT) or control (routine care) condition. The secondary outcome measures include: depression, anxiety and stress symptoms; self-efficacy; self-mastery; self-esteem; relationship quality (spouse, immediate family members); coping; and resilience. All participants will complete the aforementioned measures at baseline during pregnancy (T1), 3 months postrandomization (T2), at 8 months of pregnancy (T3), and 3 months postpartum (T4). DISCUSSION:The results of this pilot randomized controlled trial will provide data on the feasibility and acceptability of the intervention and identify necessary adaptations. This study will allow for optimization of full trial processes and inform the evaluation strategy, including sample size calculations for the full randomized controlled trial. TRIAL REGISTRATION:ClinicalTrials.gov, NCT01901796. Registered on 18 December 2014.

Project description:BackgroundMajor depressive disorder is a chronic condition; its prevalence is expected to grow with the aging trend of high-income countries. Internet-based cognitive-behavioral therapy has proven efficacy in treating major depressive disorder.ObjectiveThe objective of this study was to assess the cost-effectiveness of implementing a community internet-based cognitive behavioral therapy intervention (Super@, the Spanish program for the MasterMind project) for treating major depressive disorder.MethodsThe cost-effectiveness of the Super@ program was assessed with the Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing tool, using a 3-state Markov model. Data from the cost and effectiveness of the intervention were prospectively collected from the implementation of the program by a health care provider in Badalona, Spain; the corresponding data for usual care were gathered from the literature. The health states, transition probabilities, and utilities were computed using Patient Health Questionnaire-9 scores.ResultsThe analysis was performed using data from 229 participants using the Super@ program. Results showed that the intervention was more costly than usual care; the discounted (3%) and nondiscounted incremental cost-effectiveness ratios were €29,367 and €26,484 per quality-adjusted life-year, respectively (approximately US $35,299 and $31,833, respectively). The intervention was cost-effective based on the €30,000 willingness-to-pay threshold typically applied in Spain (equivalent to approximately $36,060). According to the deterministic sensitivity analyses, the potential reduction of costs associated with intervention scale-up would reduce the incremental cost-effectiveness ratio of the intervention, although it remained more costly than usual care. A discount in the incremental effects up to 5% exceeded the willingness-to-pay threshold of €30,000.ConclusionsThe Super@ program, an internet-based cognitive behavioral therapy intervention for treating major depressive disorder, cost more than treatment as usual. Nevertheless, its implementation in Spain would be cost-effective from health care and societal perspectives, given the willingness-to-pay threshold of €30,000 compared with treatment as usual.

Project description:BackgroundMental disorders are the leading global cause of years lived with disability; the majority of this burden exists in low and middle income countries (LMICs). Over half of mental illness is attributable to depression and anxiety disorders, both of which have known treatments. While the scarcity of mental health care providers is recognized as a major contributor to the magnitude of untreated disorders in LMICs, studies in LMICs find that evidence-based treatments for depression and anxiety disorders, such as brief, structured psychotherapies, are feasible, acceptable and have strong efficacy when delivered by local non-specialist personnel. However, most mental health treatment studies using non-specialist providers in LMICs deploy traditional efficacy designs (T1) without the benefit of integrated mental health treatment models shown to succeed over vertical interventions or methods derived from new implementation science to speed policy change. Here, we describe an effectiveness-implementation hybrid study that evaluates non-specialist delivery of mental health treatment within an HIV clinic for HIV-positive (HIV+) women affected by gender- based violence (GBV) (HIV+ GBV+) in the Nyanza region of Kenya.Methods/designIn this effectiveness-implementation hybrid type I design, 200 HIV+ women with major depressive disorder (MDD) and posttraumatic stress disorder (PTSD) who are receiving care at a Family AIDS Care Education and Services (FACES)-supported clinic in Kisumu, Kenya will be randomized to: (1) interpersonal psychotherapy (IPT) + treatment as usual (TAU) or (2) TAU, both delivered within the HIV clinic. IPT will consist of 12 weekly 60-minute individual IPT sessions, delivered by non-specialists trained to provide IPT. Primary effectiveness outcomes will include MDD and PTSD diagnosis on the Mini International Diagnostic Interview (MINI). Primary implementation outcomes will include treatment cost-benefit, acceptability, appropriateness, feasibility and fidelity of the IPT delivery within an HIV clinic.DiscussionThis trial leverages newly defined effectiveness-implementation hybrid designs to gather data on mental health treatment implementation within an HIV care clinic, while testing the effectiveness of an evidence-based treatment for use with a large underserved population (HIV+ GBV+ women) in Kenya.Trial registrationClinical trials identifierNCT02320799, registered on 9 September 2014.

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Study protocol: Hybrid Type I cost-effectiveness and implementation study of interpersonal psychotherapy (IPT) for men and women prisoners with major depression.

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Study protocol: Hybrid Type I cost-effectiveness and implementation study of interpersonal psychotherapy (IPT) for men and women prisoners with major depression.

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