James R Mckay

University of Pennsylvania | UP · Department of Psychiatry

Introduction: The Brief Addiction Monitor-Revised (BAM-R) is a widely used, 17-item assessment of substance use, risk, and protective factors associated with recovery from substance use disorders. Despite wide adoption in the U.S. Department of Veterans Affairs (VA) and recommendations for use in measurement-based care (MBC), administration may no...

Existing methods for estimation of dynamic treatment regimes are mostly limited to intention-to-treat analyses-which estimate the effect of randomization to a particular treatment regime without considering the compliance behavior of patients. In this article, we propose a novel nonparametric Bayesian Q-learning approach to construct optimal sequen...

Introduction: Opioid use disorder (OUD) and psychiatric conditions commonly co-occur yet are infrequently treated with evidence-based therapeutic approaches, resulting in poor outcomes. These conditions, separately, present challenges to treatment initiation, retention, and success. These challenges are compounded when individuals have OUD and psyc...

Existing methods for estimating the mean outcome under a given sequential treatment rule often rely on intention-to-treat analyses, which estimate the effect of following a certain treatment rule regardless of compliance behavior of patients. There are two major concerns with intention-to-treat analyses: (1) the estimated effects are often biased t...

Veterans with PTSD and SUDs often fail to initiate, or prematurely discontinue, mental health treatment in Veteran Affairs Medical Centers (VAMC). While much is known about clinical characteristics and demographic factors impacting treatment engagement in this population, less is known about the role of social factors. This retrospective study exam...

Sequential, multiple assignment, randomized trials (SMARTs) compare sequences of treatment decision rules called dynamic treatment regimes (DTRs). In particular, the Adaptive Treatment for Alcohol and Cocaine Dependence (ENGAGE) SMART aimed to determine the best DTRs for patients with a substance use disorder. While many authors have focused on a s...

Background and Aims Management of alcohol use disorder (AUD) could be enhanced by effective remote treatments. Study tested whether supplementing intensive outpatient programs (IOPs) with continuing care delivered via: (1) telephone, (2) smartphone, or (3) their combination improves outcomes relative to (4) IOP only. Continuing care conditions were...

Existing methods in estimating the mean outcome under a given dynamic treatment regime rely on intention-to-treat analyses which estimate the effect of following a certain dynamic treatment regime regardless of compliance behavior of patients. There are two major concerns with intention-to-treat analyses: (1) the estimated effects are often biased...

In many health domains such as substance-use, outcomes are often counts with an excessive number of zeros (EZ) - count data having zero counts at a rate significantly higher than that expected of a standard count distribution (e.g., Poisson). However, an important gap exists in sample size estimation methodology for planning sequential multiple ass...

Background People with opioid use disorder (OUD) often have a co-occurring psychiatric disorder, which elevates the risk of morbidity and mortality. Promising evidence supports the use of collaborative care for treating people with OUD in primary care. Whether collaborative care interventions that treat both OUD and psychiatric disorders will resul...

One of the main goals of sequential, multiple assignment, randomized trials (SMART) is to find the most efficacious design embedded dynamic treatment regimes. The analysis method known as multiple comparisons with the best (MCB) allows comparison between dynamic treatment regimes and identification of a set of optimal regimes in the frequentist set...

We tested the predictive validity of the Progress Assessment (PA), a brief counselor administered tool for use in measurement-based care for substance use disorders. The PA includes 5 items assessing relapse risk and 5 items assessing factors protective against relapse. Data were drawn from a completed study of continuing care for cocaine dependenc...

The cyclical and heterogeneous nature of many substance use disorders highlights the need to adapt the type or the dose of treatment to accommodate the specific and changing needs of individuals. The Adaptive Treatment for Alcohol and Cocaine Dependence study (ENGAGE) is a multi-stage randomized trial that aimed to provide longitudinal data for con...

Q-learning is a regression-based approach that is widely used to formalize the development of an optimal dynamic treatment strategy. Finite dimensional working models are typically used to estimate certain nuisance parameters, and misspecification of these working models can result in residual confounding and/or efficiency loss. We propose a robust...

Q-learning is a regression-based approach that is widely used to formalize the development of an optimal dynamic treatment strategy. Finite dimensional working models are typically used to estimate certain nuisance parameters, and misspecification of these working models can result in residual confounding and/or efficiency loss. We propose a robust...

Clinicians and researchers alike are increasingly interested in how best to personalize interventions. A dynamic treatment regimen is a sequence of prespecified decision rules which can be used to guide the delivery of a sequence of treatments or interventions that is tailored to the changing needs of the individual. The sequential multiple-assignm...

Background: Social networks that support recovery lead to enhanced treatment outcomes and sobriety regardless if this support stems from family, peer groups or 12-Step programs. Treatment process factors including readiness to change and commitment to abstinence also impact substance use. However, little is understood about the relationship between...

In recent years, there has been increased interest in the development of adaptive interventions across various domains of health and psychological research. An adaptive intervention is a protocolized sequence of individualized treatments that seeks to address the unique and changing needs of individuals as they progress through an intervention prog...

Sequential multiple assignment randomized trials (SMARTs) are a useful and increasingly popular approach for gathering information to inform the construction of adaptive interventions to treat psychological and behavioral health conditions. Until recently, analysis methods for data from SMART designs considered only a single measurement of the outc...

Clinicians and researchers alike are increasingly interested in how best to personalize interventions. A dynamic treatment regimen (DTR) is a sequence of pre-specified decision rules which can be used to guide the delivery of a sequence of treatments or interventions that are tailored to the changing needs of the individual. The sequential multiple...

Background: People in reentry from prison or jail (returning citizens) living with HIV and substance use problems often experience numerous stressors and are at high risk for resumed substance use. Interventions are needed to manage stress as a pathway to reduced substance use. Objective: This study explored the effect of a hatha yoga interventi...

Sequential, multiple assignment, randomized trial (SMART) designs have become increasingly popular in the field of precision medicine by providing a means for comparing sequences of treatments tailored to the individual patient, i.e., dynamic treatment regime (DTR). The construction of evidence-based DTRs promises a replacement to adhoc one-size-fi...

Sequential, multiple assignment, randomized trial (SMART) designs have become increasingly popular in the field of precision medicine by providing a means for comparing sequences of treatments tailored to the individual patient, i.e., dynamic treatment regime (DTR). The construction of evidence-based DTRs promises a replacement to adhoc one-size-fi...

Background: In 2011, the Department of Veterans Affairs launched an initiative to expand patients’ access to contingency management (CM) for the treatment of substance use disorders, particularly stimulant use disorder. This study evaluates the uptake and effectiveness of the VA initiative by presenting data on participation in coaching, fidelity t...

While continuing care for substance use treatment has been associated with reduced involvement in the criminal justice system, much of this research lacks random assignment to continuing care and so is limited by self-selection bias. This study sought to determine the impact of adding telephone-based continuing care to intensive outpatient programs...

Background: New smartphone communication technology provides a novel way to provide personalized continuing care support following alcohol treatment. One such system is the Addiction version of the Comprehensive Health Enhancement Support System (A-CHESS), which provides a range of automated functions that support patients. A-CHESS improved drinki...

Motivational interviewing (MI) is an efficacious treatment for alcohol use disorders. MI is thought to enhance motivation via a combination of 2 therapeutic strategies or active ingredients: 1 relational and 1 directional. The primary aim of this study was to examine MI’s hypothesized active ingredients using a dismantling design. Problem drinkers...

Evaluate the effect of continuing care interventions for cocaine use with HIV risk-reduction components on HIV sex-risk. Explore whether cocaine use at treatment initiation interacts with the type of continuing care intervention to affect HIV sex-risk. Cocaine dependent participants (N = 321) were randomized to: (1) Treatment as usual (TAU): intens...

Introduction Recent evidence suggests that text messaging may help to reduce problem drinking as an extension to in-person services, but very little is known about the effectiveness of remote messaging on problem drinking as a stand-alone intervention, or how different types of messages may improve drinking outcomes in those seeking to moderate the...

SMSMuenchconsortchecklist. (PDF)

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Aims: To demonstrate how Q-learning, a novel data analysis method, can be used with data from a sequential, multiple assignment, randomized trial (SMART) to construct empirically an adaptive treatment strategy (ATS) that is more tailored than the ATSs already embedded in a SMART. Method: We use Q-learning with data from the Extending Treatment E...

Background: Intimate partnerships are discouraged during early recovery, despite research that highlights their capacity to be resources for change. Objective: This study seeks to provide descriptions of intimate partnerships and how such partnerships challenge and/or support minimizing HIV sex-risk among participants in continuing care for coca...

To evaluate the effect of providing choice of treatment alternatives to patients who fail to engage in or drop out of intensive outpatient programs (IOPs) for substance dependence. Alcohol- and/or cocaine-dependent patients (N = 500) participated in a sequential, multiple-assignment, randomized trial (SMART). Those who failed to engage in an IOP at...

In an effort to increase engagement in effective treatment, we offered a choice of alternate evidence-based treatments to 137 alcohol- or cocaine-dependent adults (110 males, 27 females), who entered an intensive outpatient programme (IOP) but disengaged within the first 8 weeks. We hypothesised that disengaged patients would choose and subsequentl...

Contingency management (CM) is an empirically validated intervention but one not often applied in practice settings in the US. The aim of this article is to describe the veterans administration (VA) nationwide implementation of CM treatment. In 2011, the VA called for integration of CM in its intensive outpatient substance abuse treatment clinics....

Background and Objectives Research on face-to-face treatment for substance misuse suggests that patients' social networks may impact treatment entry and participation, but there has been no similar research on entry and participation in telephone-based continuing care. We examined whether alcohol-specific social support predicted engagement and par...

The widespread availability of high-speed, mobile cellular telephones and other advances in communication technology have the potential to change the way in which interventions for substance use disorders (SUD) are delivered and how progress is monitored. This article reviews recent research on the use of new technology to monitor progress and deli...

The goal of this study was to determine which cocaine dependent patients engaged in an intensive outpatient program (IOP) were most likely to benefit from extended continuing care (24months). Participants (N=321) were randomized to: IOP treatment as usual (TAU), TAU plus Telephone Monitoring and Counseling (TMC), or TAU plus TMC plus incentives for...

Alcohol use disorder is one of the leading causes of disability worldwide. Despite the availability of efficacious treatments, few individuals with an alcohol use disorder are actively engaged in treatment. Available evidence suggests that primary care may play a crucial role in the identification of patients with an alcohol use disorder, delivery...

Objective: Study tested whether cocaine dependent patients using cocaine or alcohol at intake or in the first few weeks of intensive outpatient treatment would benefit more from extended continuing care than patients abstinent during this period. The effect of incentives for continuing care attendance was also examined. Method: Participants (N =...

To prospectively investigate the relation between cannabis use expectancies and cannabis use prior to and during a self-initiated cannabis cessation attempt. Cohort design that followed participants for 4 weeks following a self-initiated cessation attempt. United States Department of Veterans Affairs medical center. One hundred cannabis dependent m...

Although monitoring of treatment response is standard practice for many medical conditions, practitioners in mental health treatments, and substance abuse treatment in particular, have been slow to adopt these practices. Progress monitoring (PM), consisting of measurement and feedback, has the potential to significantly improve treatment outcomes....

Objective: This study tested whether the addition of an enhanced continuing care (ECC) intervention that combined in-person and telephone sessions and began in the first week of treatment improved outcomes for cocaine-dependent patients entering an intensive outpatient program (IOP). Method: Participants (N = 152) were randomized to IOP treatmen...

The goal was to identify factors that predicted sustained cocaine abstinence and transitions from cocaine use to abstinence over 24months. Data from baseline assessments and multiple follow-ups were obtained from three studies of continuing care for patients in intensive outpatient programs (IOPs). In the combined sample, remaining cocaine abstinen...

While it is known that community-based outpatient treatment for substance abusing offenders is effective, treatment completion rates are low and much of the prior research has been conducted with offenders in residential treatment or therapeutic communities. The aim of the present study was to assess whether offenders who are mandated to community-...

Objective: This study assessed whether adding a telephone care management protocol to usual aftercare improved the outcomes of veterans in the year after they were discharged from residential treatment for posttraumatic stress disorder (PTSD). Methods: In a multisite randomized controlled trial, 837 veterans entering residential PTSD treatment w...

Motivational interviewing (MI) is an effective treatment for substance use disorders (SUDs) that focuses on resolving ambivalence and increasing commitment to positive behavior change. Although MI has a well-developed clinical theory, research findings have been mixed in supporting its view of how change occurs. The primary aim of this pilot study...

This project developed and tested a 17-item monitoring instrument covering important substance use related behaviors to support measurement-based care and outcomes assessment. The study consisted of two phases, an instrument development phase and an initial study to examine its psychometric properties. Participants were 175 patients entering VA out...

Pharmacogenetic and adaptive treatment approaches can be used to personalize care for alcohol-dependent patients. Preliminary evidence shows that variation in the gene encoding the μ-opioid receptor moderates the response to naltrexone when used to treat alcohol dependence. Studies have also shown moderating effects of variation in the gene encodin...

The central aim of this administrative data analysis was to examine usage of a Web-based disease management program designed to provide continuing recovery support to patients discharged from residential drug and alcohol treatment. Tailored clinical content was delivered in a multimedia format over the course of 18 months posttreatment. The program...

Aims To determine whether 18 months of telephone continuing care improves 24-month outcomes for patients with alcohol dependence. Subgroup analyses were performed to identify patients who would benefit most from continuing care. Design Comparative effectiveness trial of continuing care that consisted of monitoring and feedback only (TM) or monitori...

Continuing care following initial substance use disorder treatment often is associated with improved treatment outcomes and evidence-based interventions (EBIs) have been developed in this area. However, rates of patient participation in continuing care treatment and mutual help groups (MHGs) are low and a large gap exists between the existing EBIs...

Reviews of the continuing care research literature indicate that interventions that feature longer planned durations and active efforts to deliver the treatment components are more likely to show positive effects than other interventions. However, this literature has a number of limitations, including a focus on inpatient samples, treatment complet...

For many patients, alcohol and other drug (AOD) use disorders are chronic, recurring conditions involving multiple cycles of treatment, abstinence, and relapse. To disrupt this cycle, treatment can include continuing care to reduce the risk of relapse. The most commonly used treatment approach is initial intensive inpatient or outpatient care based...

To evaluate potential moderators of the effect of adding extended telephone monitoring (TM) and telephone monitoring and counseling (TMC) continuing care to treatment as usual (TAU) for alcoholism. Continuing care was predicted to be more effective for patients with severe substance-use histories, poor initial response to treatment, and other risk...

To identify key features of interventions that need to be considered in the design, execution, and reporting of interventions. Based on prior work on decomposing psychosocial and clinical interventions, current guidelines for describing interventions, and a review of a broad range of intervention studies, we developed a comprehensive intervention t...

To explore issues of intervention tailoring for ethnic minorities based on information and experiences shared by researchers affiliated with the Health Maintenance Consortium (HMC). A qualitative case study methodology was used with the administration of a survey (n = 17 principal investigators) and follow-up telephone interviews. Descriptive and c...

Telephone-based monitoring is a promising approach to continuing care of substance use disorders, but patients often do not engage or participate enough to benefit. Voucher incentives can increase retention in outpatient treatment and continuing care, but may be less effective when reinforcement is delayed, as in telephone-based care. We compared t...

The study tested whether adding up to 18 months of telephone continuing care, either as monitoring and feedback (TM) or longer contacts that included counseling (TMC), to intensive outpatient programs (IOPs) improved outcomes for alcohol-dependent patients. Participants (N = 252) who completed 3 weeks of IOP were randomized to up to 36 sessions of...

The COMBINE (combined pharmacotherapies and behavioral intervention) clinical trial recently evaluated the efficacy of pharmacotherapies, behavioral therapies, and their combinations for the treatment of alcohol dependence. Previously, the cost and cost-effectiveness of COMBINE have been studied. Policy makers, patients, and nonalcohol-dependent in...

Most cost and cost-effectiveness studies of substance abuse treatments focus on the costs to the provider/payer. Although this perspective is important, the costs incurred by patients should also be considered when evaluating treatment. This article presents estimates of patients' costs associated with the Combined Pharmacotherapies and Behavioral...

In this study, the authors evaluated the psychometric properties of the Treatment Program Progress (TPP) rating scale, a brief instrument that assesses counselor ratings of patient response to 12-step–oriented substance abuse treatment interventions. In both 3- and 5-day-per-week outpatient programs, the TPP bad good internal consistency reliabilit...

The effects of cognitive-behavioral relapse prevention (RP), contingency management (CM), and their combination (CM + RP) were evaluated in a randomized trial with 100 cocaine-dependent patients (58% female, 89% African American) who were engaged in treatment for at least 2 weeks and had an average of 44 days of abstinence at baseline. The particip...

This study tested whether coordinated care management, a continuity of care intervention for substance-use disorders, improved employment among men and women on public assistance compared with usual welfare management. Participants were 421 welfare applicants identified via substance-use-disorder screening and assigned via a computerized allocation...

Studies demonstrating greater problem severity in substance abuse patients with posttraumatic stress disorder (PTSD) versus those without have rarely considered other co-occurring psychiatric disorders. This study of 466 male veterans recently admitted to outpatient substance abuse treatment attempts to identify problems associated with PTSD versus...

In the field of addiction treatment, the term continuing care has been used to indicate the stage of treatment that follows an initial episode of more intensive care. This article reviews controlled studies of continuing care conducted over the prior 20 years. The results indicate that continuing care interventions were more likely to produce posit...

This study tested whether coordinated care management (CCM), a continuity of care intervention for substance use disorders (SUD), improved rates of abstinence when compared with usual welfare management for substance-using single adults and adults with dependent children applying for public assistance. The study was designed as a practical clinical...

More than 10% of the U.S. population meets DSM-IV criteria for substance use disorders, according to recent estimates. Although effective interventions have been identified for substance abuse, a significant percentage of patients respond poorly to them. This variability in patient response highlights the need for adaptive models of care—that is, t...

This article reviews recent developments in the field of alcoholism treatment research. The following major topics are addressed: the relative efficacy and cost-effectiveness of various treatment approaches, the use of brief interventions, the identification of patient-treatment matches and treatment processes that predict better outcomes, the effi...

There is increasing evidence that a chronic care model may be effective when treating substance use disorders. In 1996, the Betty Ford Center (BFC) began implementing a telephone-based continuing care intervention now called Focused Continuing Care (FCC) to assist and support patients in their transition from residential treatment to longer-term re...

The chronic and relapsing nature of substance abuse points to the need for continuing care after a primary phase of treatment. This article reviews the economic studies of continuing care, discusses research gaps, highlights some of the challenges of conducting rigorous economic evaluations of continuing care, and offers research guidelines and rec...

This pilot study (N = 30) experimentally examined the effects of an adaptive intervention in an adult misdemeanor drug court. The adaptive algorithm adjusted the frequency of judicial status hearings and clinical case-management sessions according to pre-specified criteria in response to participants' ongoing performance in the program. Results rev...

In addictions treatment research, there has been a relative paucity of work on mechanisms of action that account for observed treatment effects. In studies that have been done, there is little evidence that the purported active ingredients of behavioral interventions such as cognitive-behavioral treatment or motivational interviewing actually media...

A previous randomized trial with 224 alcohol and/or cocaine addicts who had completed an initial phase of treatment indicated that 12 weeks of telephone-based continuing care yielded higher abstinence rates over 24 months than did group counseling continuing care. The current study examined mediators of this treatment effect. Results suggested that...

Over the last three decades, the randomized controlled trial or 'psychotherapy technology' approach has been the dominant model of inquiry in research on addiction treatment. This period has yielded impressive discoveries, but recent failures to confirm core research hypotheses such as occurred in Project MATCH and the Cocaine Collaborative Treatme...

For many individuals, substance abuse possesses characteristics of chronic disorders in that individuals experience repeated cycles of cessation and relapse; hence viewing drug dependence as a chronic, relapsing disorder is increasingly accepted. The development of a treatment for a chronic disorder requires consideration of the ordering of treatme...

Newer models of continuing care in the addictions are designed to improve the long-term management of substance use disorders by engaging patients into flexible, or "adaptive," treatment algorithms that change in focus and intensity as symptoms wax and wane over time. This article describes some of these newer approaches to the management of substa...