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A qualitative study was conducted to assess interest in contingency management (CM) for younger American Indian (AI) adults (18-29 years old), how to culturally and developmentally adapt CM for younger AI adults, and interest in CM relative to culturally grounded treatment approaches. We conducted a total of four focus groups with younger adults and families in two AI communities: a rural reservation and an urban Indian health clinic (n = 32). Four overarching themes emerged suggesting that offering prizes, cultural activities, and activities that capture the attention of younger adults integrated into the CM intervention is ideal for enhancing engagement.

Introduction: Many American Indian and Alaska Native (AI/AN) people seek evidence-based, cost-effective, and culturally acceptable solutions for treating alcohol use disorders. Contingency management (CM) is a feasible, low-cost approach to treating alcohol use disorders that uses "reinforcers" to promote and support alcohol abstinence. CM has not been evaluated among AI/AN communities. This study explored the cultural acceptability of CM and adapted it for use in diverse AI/AN communities., Methods: We conducted a total of nine focus groups in three AI/AN communities: a rural reservation, an urban health clinic, and a large Alaska Native healthcare system. Respondents included adults in recovery, adults with current drinking problems, service providers, and other interested community members (n = 61). Focus group questions centered on the cultural appropriateness of "reinforcers" used to incentivize abstinence and the cultural acceptability of the intervention. Focus groups were audio-recorded, transcribed, and coded independently by two study team members using both a priori and emergent codes. We then analyzed coded data., Results: Across all three locations, focus group participants described the importance of providing both culturally specific (e.g., bead work and cultural art work supplies), as well as practical (e.g., gas cards and bus passes) reinforcers. Focus group participants underscored the importance of providing reinforcers for the children and family of intervention participants to assist with reengaging with family and rebuilding trust that may have been damaged during alcohol use. Respondents indicated that they believed CM was in alignment with AI/AN cultural values. There was consensus that Elders or a well-respected community member implementing this intervention would enhance participation. Focus group participants emphasized use of the local AI/AN language, in addition to the inclusion of appropriate cultural symbols and imagery in the delivery of the intervention., Conclusions: A CM intervention for alcohol use disorders should be in alignment with existing cultural and community practices such as alcohol abstinence, is more likely to be successful when Elders and community leaders are champions of the intervention, the intervention is compatible with counseling or treatment methodologies, and the intervention provides rewards that are both culturally specific and practical., (Copyright © 2018 Elsevier Inc. All rights reserved.)

In the context of a contingency management (CM) implementation/effectiveness hybrid trial, the post-training implementation domains of direct-care clinicians (N=19) were examined in relation to a targeted clinical outcome of subsequently CM-exposed clients. Clinicians' CM skillfulness, a behavioral measure of their capability to skillfully deliver the intended CM intervention, was found to be a robust and specific predictor of their subsequent client outcomes. Analyses also revealed CM skillfulness to: (1) fully mediate an association between a general therapeutic effectiveness and client outcome, (2) partially mediate an association of in-training exposure to CM and client outcome, and (3) be composed of six component clinical practice behaviors that each contributed meaningfully to this behavior fidelity index. Study findings offer preliminary evidence of the predictive validity of post-training CM skillfulness for subsequent client outcomes, and inform suggestions for the design and delivery of skills-focused CM training curricula for the addiction treatment workforce., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Disproportionately high rates of alcohol use disorders are present in many American Indian/Alaska Native (AI/AN) communities, yet little information exists regarding the effectiveness of alcohol treatments in AI/AN populations. Contingency management is an intervention for illicit drug use in which tangible reinforcers (rewards) are provided when patients demonstrate abstinence as assessed by urine drug tests. Contingency management has not been widely studied as an intervention for alcohol problems because until recently, no alcohol biomarker has been available to adequately verify abstinence., Aims: The HONOR Study is designed to determine whether a culturally-tailored contingency management intervention is an effective intervention for AI/AN adults who suffer from alcohol use disorders., Methods: Participants include 400 AI/AN alcohol-dependent adults residing in one rural reservation, one urban community, as well as a third site to be decided, in the Western U.S. Participants complete a 4-week lead-in phase prior to randomization, then 12 weeks of either a contingency management intervention for alcohol abstinence, or a control condition where participants receive reinforcers for attending study visits regardless of alcohol use. Participants are then followed for 3-more months post-intervention. The primary study outcome is urinary ethyl glucuronide-confirmed alcohol abstinence; secondary outcomes include self-reported alcohol and drug use, HIV risk behaviors, and self-reported cigarette smoking., Discussion: This will be the largest randomized, controlled trial of any alcohol for AI/ANs and the largest contingency management study targeting alcohol use disorders, thus providing important information to AI/AN communities and the alcohol treatment field in general., (Copyright © 2015. Published by Elsevier Inc.)

Background: The primary analyses of the COMBINE Study revealed significant naltrexone and Combined Behavioral Intervention (CBI) main effects on drinking outcomes but failed to find additional benefits of the combination of treatments. Investigating differences in patterns of adherence over time may shed light on the treatment effects in COMBINE. The goals of the study were to identify trajectories of medication adherence and participation in CBI, to estimate predictive and moderating effects of adherence trajectories on drinking outcomes and to characterize subjects in adherence trajectories. The results of these analyses may suggest approaches to improving adherence in order to ultimately improve treatment outcome., Methods: We used a trajectory-based approach to identify patterns of treatment adherence separately for naltrexone, acamprosate and CBI adherence. Logistic regression and general linear models assessed associations among adherence trajectories, drinking outcomes and patient characteristics., Results: Three trajectories of adherence were identified for each treatment: "excellent adherers", "late non-adherers" and "early non-adherers" and there was good agreement among adherence trajectories with different treatments. "Excellent adherers" had significantly higher percent days abstinent (PDA) and lower percent heavy drinking days (PHDD). CBI significantly decreased PHDD for subjects on acamprosate in the "early non-adherers with medication" trajectory (p=0.01). Either naltrexone or acamprosate was associated with lower PHDD than placebo for "early non-adherers with CBI" (p<0.01). Receiving active medication decreased the likelihood to be in the excellent medication adherence trajectory. Younger age, greater drinking severity, dissatisfaction with the medicine and session frequency, adverse events and lack of benefit were related to less favorable medication adherence trajectories. "Excellent adherers with CBI" were significantly more satisfied with the CBI counselor., Conclusions: Patterns of treatment adherence appear to be a participant characteristic. Individuals who fail to adhere early in treatment have worse outcomes regardless of treatment. However, treatment outcomes of participants who exhibit early problems with adherence to one treatment modality could potentially be improved by offering an alternative behavioral or pharmacologic treatment., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Empirically-supported treatments for alcohol dependence exist, yet understanding of influences contributing to the intended behavior change is limited. The current study, a secondary analysis of the recent multisite COMBINE trial (The COMBINE Study Research Group, 2003), tested a mediational model wherein change in client self-efficacy for abstinence was examined as a potential mediator of associations between client report of the therapeutic bond and one-year outcomes of drinking frequency, drinking consequences, and psychiatric functioning. For analyses, the 1383 COMBINE trial participants were grouped as follows: 1) those receiving study medications (naltrexone, acamprosate, naltrexone + acamprosate, placebo) and enrolled in medication management (MM) only (n = 607), 2) those receiving study medications/MM and also enrolled in a combination behavioral intervention (CBI) as well (n = 619), and 3) those enrolled in CBI only (n = 157). Mediation analyses using the product-of-coefficients approach indicated self-efficacy change during treatment significantly mediated associations between the therapeutic bond with the CBI therapist and each of the three one-year outcomes among those exclusively receiving CBI, but failed to do so among those receiving pills/MM (with or without CBI). Effect sizes were small, but indicated that variance in bond-outcome associations was partially mediated by self-efficacy change for trial participants. Findings advance understanding of proximal client change processes during delivery of treatments for alcohol dependence., (PsycINFO Database Record (c) 2011 APA, all rights reserved).)

Objective: COMBINE is the largest study of pharmacotherapy for alcoholism in the United States to date, designed to answer questions about the benefits of combining behavioral and pharmacological interventions. Trajectory-based analyses of daily drinking data allowed identification of distinct drinking trajectories in smaller studies and demonstrated significant naltrexone effects even when primary analyses on summary drinking measures were unsuccessful. The objective of this study was to replicate and refine trajectory estimation and to assess effects of naltrexone, acamprosate and therapy on the probabilities of following particular trajectories in COMBINE. It was hypothesized that different treatments may affect different trajectories of drinking., Methods: We conducted exploratory analyses of daily indicators of any drinking and heavy drinking using a trajectory-based approach and assessed trajectory membership probabilities and odds ratios for treatment effects., Results: We replicated the trajectories ("abstainer", "sporadic drinker", "consistent drinker") established previously in smaller studies. However, greater numbers of trajectories better described the heterogeneity of drinking over time. Naltrexone reduced the chance to follow a "nearly daily" trajectory and Combined Behavioral Intervention (CBI) reduced the chance to be in an "increasing to nearly daily" trajectory of any drinking. The combination of naltrexone and CBI increased the probability of membership in a trajectory in which the frequency of any drinking declined over time. Trajectory membership was associated with different patterns of treatment compliance., Conclusion: The trajectory-analyses identified specific patterns of drinking that were differentially influenced by each treatment and provided support for hypotheses about the mechanisms by which these treatments work., (Copyright 2009 Elsevier Ireland Ltd. All rights reserved.)

Objective: This article argues that nondrinking outcomes are essential to include in complex trials such as COMBINE to assess the hypothesized mechanisms of action and behavioral change associated with both medications and psychotherapy. Toward this end, COMBINE is used as a case study for (1) discussing hypothesized mechanisms of action for behavior change, (2) discussing distinctive design features of combined studies, (3) highlighting issues in the selection of outcome measures, (4) providing a framework for organizing outcome domains and measures and (5) providing a dose-response model for assessing alcoholism treatment outcomes., Method: A review of the literature and discussion of methodological issues in assessing nondrinking outcomes is provided as well as a case study in developing a conceptual framework for selecting outcome measures., Results: The results of the review and case study include the development of a framework for categorizing outcome dimensions and measures into condition-specific clinical status, condition-specific symptoms and personal and interpersonal functioning outcomes. In addition, a model is provided for assessing the dose-response of combined alcoholism treatment with multiple dimensions of outcome during and after treatment., Conclusions: Consistent with previous observations that recovery from alcohol dependence is a multidimensional developmental process, the COMBINE Study will examine the effects of different combinations of pharmacotherapy and behavioral interventions on the magnitude and pattern of changes in various outcome dimensions (both drinking and nondrinking) over time.

Objective: Baseline assessment in a multisite alcohol-dependence treatment study has several purposes: addressing inclusion/exclusion criteria and characterizing participants to illuminate subsequent efficacy and safety patterns of the interventions. Combination pharmacotherapy and behavioral therapy trials, however, require more complex assessments than single-modality studies. Medication trials require measures of initial safety for study drug as well as for subsequent side-effect and adverse-effect monitoring (e.g., physical examination, laboratory markers, somatic symptoms, medical conditions and concomitant medications). Behavioral therapy trials (and in some cases medication trials) warrant baseline measurement of mediators of therapy effect (e.g., prior treatment history, motivation for change, self-efficacy, other psychiatric conditions, treatment expectations and network supports). Measures may be needed to interpret interactions that may be discovered between these modalities., Method: The National Institute on Alcohol Abuse and Alcoholism COMBINE Study evaluated the potentially overwhelming number of candidate instruments through an iterative process, using the following sequence to finalize a rational baseline assessment battery: key constructs, representative measures, determination of duration of assessment, risk of assessment reactivity, goal priorities, necessity for measure "pruning" and order of measure presentation. After selecting the draft battery, feasibility was evaluated in a pilot study prior to the main trial., Results: The battery was feasible to administer and avoided unintended selection bias. Dropout was substantial, however, and differences across sites in baseline assessment completion rates reflected a tendency of a central intake model to function as an initial filter of dropouts, compared with a direct recruitment model., Conclusions: This process holds several potentially useful lessons for investigators.

Objective: Given the national trend toward integrating substance abuse treatment into medical practice, experts in the field of alcoholism designed a psychosocial, medically based intervention to be used with pharmacotherapy in the COMBINE multisite national study, supported by the National Institute on Alcohol Abuse and Alcoholism. A main purpose of the COMBINE Study is to investigate optimal treatment for patients with alcohol dependence by combining pharmacotherapy and psychosocial interventions., Method: The medically based intervention, called Medical Management (MM), was specifically constructed to be implemented by medically trained practitioners in nonspecialty settings. Each visit includes evaluations of medication safety and adherence, monitoring of alcohol use and direct advice to the patient for achieving full recovery., Results: There are several themes implicit in MM. Patient education about the disorder and about the treatment being provided are both essential. The clinician also educates the patient about how he or she has been affected by alcohol dependence. Information is given on how to take the medication(s) as prescribed, what the patient should expect from the medication(s) and what kinds of events the clinician will need to know about during treatment. Finally, the clinician and patient discuss strategies for ensuring medication safety and adherence to the prescribed regimen., Conclusions: MM was easily implemented in the COMBINE Study with the aid of the MM Treatment Manual.

Objective: The present article reviews the literature to date dealing with quality of life (QoL) as it relates to drinking behavior, alcohol use disorders and treatment outcome., Method: Articles using the term "quality of life" to describe a status or outcome construct for individuals diagnosed with or being treated for alcohol use disorders or that used one or more instruments considered to reflect patients' QoL were identified primarily through Psychological Abstracts, MEDLINE and the National Institute on Alcohol Abuse and Alcoholism's ETOH archival database., Results: Thirty-six studies, published between 1993 and 2004, met these criteria. Twelve different QoL measures were used. Frequent heavy drinking or episodic heavy drinking (e.g., five or more drinks per occasion) patterns were associated with reduced QoL. Alcoholics had lower levels of QoL compared with general population norms or with other chronic health conditions. This relationship appears to be moderated by a number of sociodemographic and client characteristics, such as age, education, gender and co-occurring psychiatric disorders. Alcohol-dependent individuals experience improvements in QoL across treatment and with both short-term and long-term abstinence. Despite these improvements, many alcoholic individuals' QoL is unlikely to equal or exceed that of normative groups. Also, among hazardous and harmful drinkers, achieving and maintaining a marked reduction in drinking, even without complete abstinence, is associated with significant increases in QoL., Conclusions: QoL represents an important area to consider in assessing individuals with alcohol use disorders and in evaluating alcoholism treatment outcome.

Project MATCH (Matching Alcoholism Treatments to Client Heterogeneity) is a multisite collaborative project designed to evaluate patient-treatment interactions in alcoholism treatment. To evaluate whether major threats to the internal validity of the independent (treatment) variable in Project MATCH could be ruled out, we investigated several aspects of treatment integrity and discriminability. In this study, 1,726 alcohol-dependent participants at 10 sites were randomized to 3 treatments: cognitive-behavioral treatment (CBT), motivational enhancement therapy (MET), and 12-step facilitation (TSF). Participants received treatment either as outpatients or as aftercare following a more intensive inpatient or day hospital treatment. For both the outpatient and aftercare arms of the study, treatments were discriminable in that therapists implemented each of the treatments according to manual guidelines and rarely used techniques associated with comparison approaches. Participants received a high level of exposure to their study treatments, and the intended contrast in treatment dose between MET and the 2 more intensive treatments (CBT and TSF) was obtained. Alcoholics Anonymous involvement was significantly higher for participants assigned to TSF versus MET or CBT, whereas the treatments did not differ in utilization of other nonstudy treatments. Nonspecific aspects of treatment such as therapist skillfulness and level of the therapeutic alliance were comparable across treatment conditions.

Behavioral approaches have made significant contributions to understanding the etiology and treatment of alcohol dependence. The present chapter provides a brief overview of changes that have occurred within this perspective over the past decade. Significant changes at a theoretical level have included a move toward mediational cognitive-behavioral models of etiology and maintenance, integrative multivariate models, and an empirical, developmental model based on the natural history of the drinking and alcohol problems. Significant changes in clinical practice have included an expanded role of assessment within the context of a biopsychosocial model of alcoholism, an increased focus on secondary prevention and brief intervention with less-alcohol-impaired individuals, a focus on "harm reduction" as a goal of such interventions, the development of a stepped-care approach to treatment with a reliance on patient-treatment matching, an increased emphasis on the maintenance of therapeutic gain and relapse prevention, and the incorporation of behavioral and cognitive principles into self-help programs.

Randomly assigned 44 outpatient Ss, enrollees of the George Washington University Health Plan, a Health Maintenance Organization (HMO), to one of three treatment modalities: (1) a cognitive behavior therapy group; (2) a traditional process-oriented interpersonal group; and (3) cognitive behavior therapy in an individual format. All Ss were referred by their physicians to the HMO Mental Health Practice for treatment for anxiety and/or depression. Beck's Depression Inventory, Speilberger's State-Trait Anxiety Inventory and Gay and Galassi's Adult Self-Expression Scale (an assertion measure) were administered pre- and post-treatment to all Ss. A subsample of these Ss also were rated pre- and post-treatment on the Hamilton Rating Scale for Depression by experienced clinicians blind to the treatment groups. All three experimental groups significantly improved on all dependent measures from pre- to post-treatment, and no differential treatment effects were found.

Controlled study showed skills training for the management of depression in an epilepsy population to be effective. Cognitive-behavioral methods were utilized in a structured learning format with 13 clinically depressed epileptic "students." Significantly greater reductions in dysphoria/depression as measured by the Depression Adjective Checklist and the Generalized Contentment Scale occurred among Ss in the treatment group than among control group Ss. Significant decreases in anger and anxiety/stress and increases in social activities were noted on the Community Adjustment Questionnaire (CAQ). Similar trends were evident on the Beck Depression Inventory and the CAQ depression scale.