Brian D. Kiluk

A Methodological Analysis of Randomized Clinical Trials of Computer-Assisted Therapies for Psychiatric Disorders: Toward Improved Standards for an Emerging Field

OBJECTIVE Computer-assisted therapies offer a novel, cost-effective strategy for providing evidence-based therapies to a broad range of individuals with psychiatric disorders. However, the extent to which the growing body of randomized trials evaluating computer-assisted therapies meets current standards of methodological rigor for evidence-based interventions is not clear. METHOD A methodological analysis of randomized clinical trials of computer-assisted therapies for adult psychiatric disorders, published between January 1990 and January 2010, was conducted. Seventy-five studies that examined computer-assisted therapies for a range of axis I disorders were evaluated using a 14-item methodological quality index. RESULTS Results indicated marked heterogeneity in study quality. No study met all 14 basic quality standards, and three met 13 criteria. Consistent weaknesses were noted in evaluation of treatment exposure and adherence, rates of follow-up assessment, and conformity to intention-to-treat principles. Studies utilizing weaker comparison conditions (e.g., wait-list controls) had poorer methodological quality scores and were more likely to report effects favoring the computer-assisted condition. CONCLUSIONS While several well-conducted studies have indicated promising results for computer-assisted therapies, this emerging field has not yet achieved a level of methodological quality equivalent to those required for other evidence-based behavioral therapies or pharmacotherapies. Adoption of more consistent standards for methodological quality in this field, with greater attention to potential adverse events, is needed before computer-assisted therapies are widely disseminated or marketed as evidence based.

Computer-Assisted Delivery of Cognitive-Behavioral Therapy: Efficacy and durability of CBT4CBT among cocaine-dependent individuals maintained on methadone

OBJECTIVE A previous pilot trial evaluating computer-based training for cognitive-behavioral therapy (CBT4CBT) in 77 heterogeneous substance users (alcohol, marijuana, cocaine, and opioids) demonstrated preliminary support for its efficacy in the context of a community-based outpatient clinic. The authors conducted a more definitive trial in a larger, more homogeneous sample. METHOD In this randomized clinical trial, 101 cocaine-dependent individuals maintained on methadone were randomly assigned to standard methadone maintenance or methadone maintenance with weekly access to CBT4CBT, with seven modules delivered within an 8-week trial. RESULTS Treatment retention and data availability were high and comparable across the treatment conditions. Participants assigned to the CBT4CBT condition were significantly more likely to attain 3 or more consecutive weeks of abstinence from cocaine (36% compared with 17%; p<0.05, odds ratio=0.36). The group assigned to CBT4CBT also had better outcomes on most dimensions, including urine specimens negative for all drugs, but these reached statistical significance only for individuals completing the 8-week trial (N=69). Follow-up data collected 6 months after treatment termination were available for 93% of the randomized sample; these data indicate continued improvement for those assigned to the CBT4CBT group, replicating previous findings regarding its durability. CONCLUSIONS This trial replicates earlier findings indicating that CBT4CBT is an effective adjunct to addiction treatment with durable effects. CBT4CBT is an easily disseminable strategy for broadening the availability of CBT, even in challenging populations such as cocaine-dependent individuals enrolled in methadone maintenance programs.

Cognitive Function and Treatment Response in a Randomized Clinical Trial of Computer-Based Training in Cognitive-Behavioral Therapy

Cognitive-behavioral therapy (CBT), because of its comparatively high level of cognitive demand, is likely to be challenging for substance users with limitations in cognitive function. However, it is not known whether computer-assisted versions of CBT will be particularly helpful (e.g., allowing individualized pace and repetition) or difficult (e.g., via complexity of computerized delivery) for such patients. In this secondary analysis of data collected from a randomized clinical trial evaluating computer-assisted CBT, four aspects of cognitive functioning were evaluated among 77 participants. Those with higher levels of risk taking completed fewer sessions and homework assignments and had poorer substance use outcomes.

Technology-based interventions for the treatment and recovery management of substance use disorders: A JSAT special issue

A growing line of research has highlighted the promising role that interactive web and mobile technologies may play in improving the effectiveness, cost-effectiveness, and reach of efforts to assess, prevent, treat, and support the recovery management of substance use disorders and other risk behavior. Manuscripts in this special issue of the Journal of Substance Abuse Treatment focus on the application of technology to the delivery of interventions for the treatment and recovery management of substance use disorders. These manuscripts are intended to highlight the diversity and current state of the science of empirically-supported innovations in this area of intervention delivery. The included manuscripts range from experimental evaluations of a variety of types of technology-based interventions (brief interventions, behavior therapy, medication adherence tools, and HIV prevention interventions) and technology platforms (mobile, Web, videoconferencing, and telephone-based interactive voice response), for an array of populations (adults, adolescents, criminal justice populations, and post-partum women), in a number of different settings (addiction specialty treatment programs, schools, emergency rooms, and criminal justice settings). They additionally reflect a variety of experimental research designs, including those focused on the design, development, and clinical evaluation of these technology-based therapeutic tools, as well as research focused on models for their successful implementation and sustained use.

Toward empirical identification of a clinically meaningful indicator of treatment outcome: features of candidate indicators and evaluation of sensitivity to treatment effects and relationship to one year follow up cocaine use outcomes.

BACKGROUND Selection of an appropriate indictor of treatment response in clinical trials is complex, particularly for the various illicit drugs of abuse. Most widely used indicators have been selected based on expert group recommendation or convention rather than systematic empirical evaluation. Absence of an evidence-based, clinically meaningful index of treatment outcome hinders cross-study evaluations necessary for progress in addiction treatment science. METHOD Fifteen candidate indicators used in multiple clinical trials as well as some proposed recently are identified and discussed in terms of relative strengths and weaknesses (practicality, cost, verifiability, sensitivity to missing data). Using pooled data from five randomized controlled trials of cocaine dependence (N=434), the indicators were compared in terms of sensitivity to the effects of treatment and relationship to cocaine use and general functioning during follow-up. RESULTS Commonly used outcome measures (percent negative urine screens; percent days of abstinence) performed relatively well in that they were sensitive to the effects of the therapies evaluated. Others, including complete abstinence and reduction in frequency of use, were less sensitive to effects of specific therapies and were very weakly related to cocaine use or functioning during follow-up. Indicators more strongly related to cocaine use during follow-up were those that reflected achievement of sustained periods of abstinence, particularly at the end of treatment. CONCLUSIONS These analyses did not demonstrate overwhelming superiority of any single indicator, but did identify several that performed particularly poorly. Candidates for elimination included retention, complete abstinence, and indicators of reduced frequency of cocaine use.

Contingency Management to reduce substance use in individuals who are homeless with co-occurring psychiatric disorders.

Homeless shelters provide a unique opportunity to intervene with occupants who have substance abuse problems, as not addressing these issues may lead to continuation of problems playing a contributing role in homelessness. Attempts to implement Contingency Management (CM) with this population have often been complex, costly, and not straightforward to replicate in community settings. We conducted a randomized trial evaluating a simple, low-cost 4-week CM program for 30 individuals seeking shelter in a community-based homeless shelter who had both current substance and psychiatric disorders. Behavioral assessments were performed at baseline, weekly, and termination of the study. Overall retention in the trial was high; participants assigned to CM reduced their cocaine and alcohol use more than those in assessment-only. This pilot trial suggests that application of low-cost CM procedures is feasible within this novel setting and may decrease substance use.

The Short Inventory of Problems – Revised (SIP-R): Psychometric properties within a large, diverse sample of substance use disorder treatment seekers

Assessment of the adverse consequences of substance use serves an important function in both clinical and research settings, yet there is no universally agreed upon measure of consequences relevant to multiple types of substance use disorders. One of the most commonly used measures, the Short Inventory of Problems (SIP), has been adapted and evaluated in several specific populations, but evidence is needed of its reliability and validity across broader samples of persons with substance use disorders. This study evaluated the psychometric properties of a revised version of the SIP (SIP-R) in a large combined sample of alcohol and drug use disorder treatment seekers, with participants pooled from two national, multisite, randomized clinical trials. A total of 886 participants across 10 outpatient treatment facilities completed a common assessment battery that included the SIP-R, Addiction Severity Index (ASI), University of Rhode Island Change Assessment (URICA), HIV Risk Behavior Scale (HRBS), and a substance use calendar. Results supported the SIP-Rs internal reliability (α = .95). Confirmatory factor analysis demonstrated that the hypothesized 5-factor model with one higher-order factor produced the best fit. Convergent validity was evident through the SIP-Rs correlation with several composite scores from the ASI and the URICA, and analyses supported its conceptual distinction from quantity indices of drug/alcohol use. The SIP-R also demonstrated an ability to predict treatment retention, with higher scores associated with poorer retention. These results provide support for the SIP-Rs psychometric properties as a measure of consequences across a broad sample of treatment-seeking drug and alcohol users.

New Developments in Behavioral Treatments for Substance Use Disorders

After decades of defining which behavioral treatments are effective for treating addictions, the focus has shifted to exploring how these treatments work, how best to disseminate and implement them in the community, and what underlying factors can be manipulated in order to increase the rates of treatment success. These pursuits have led to advances in our understanding of the mechanisms of treatment effects, the incorporation of technology into the delivery of current treatments and development of novel applications to support relapse prevention, as well as the inclusion of neurocognitive approaches to target the automatic and higher-order processes underlying addictive behaviors. Although such advances have the promise of leading to better treatments for more individuals, there is still much work required for these promises to be realized. The following review will highlight some of these recent developments and provide a glimpse into the future of behavioral treatments.

Measures of outcome for stimulant trials: ACTTION recommendations and research agenda.

BACKGROUND The development and approval of an efficacious pharmacotherapy for stimulant use disorders has been limited by the lack of a meaningful indicator of treatment success, other than sustained abstinence. METHODS In March, 2015, a meeting sponsored by Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) was convened to discuss the current state of the evidence regarding meaningful outcome measures in clinical trials for stimulant use disorders. Attendees included members of academia, funding and regulatory agencies, pharmaceutical companies, and healthcare organizations. The goal was to establish a research agenda for the development of a meaningful outcome measure that may be used as an endpoint in clinical trials for stimulant use disorders. RESULTS AND CONCLUSIONS Based on guidelines for the selection of clinical trial endpoints, the lessons learned from prior addiction clinical trials, and the process that led to identification of a meaningful indicator of treatment success for alcohol use disorders, several recommendations for future research were generated. These include a focus on the validation of patient reported outcome measures of functioning, the exploration of patterns of stimulant abstinence that may be associated with physical and/or psychosocial benefits, the role of urine testing for validating self-reported measures of stimulant abstinence, and the operational definitions for reduction-based measures in terms of frequency rather than quantity of stimulant use. These recommendations may be useful for secondary analyses of clinical trial data, and in the design of future clinical trials that may help establish a meaningful indicator of treatment success.

What happens in treatment doesn't stay in treatment: cocaine abstinence during treatment is associated with fewer problems at follow-up.

OBJECTIVE Cocaine users often present to treatment with a multitude of problems typically considered addiction related; however, there is little evidence that reductions in cocaine use are followed by reductions in these problems. This study evaluated the relationship between rates of cocaine use during treatment and the level of non-cocaine life problems experienced during a 12-month period following treatment in a pooled sample of 434 cocaine-dependent individuals participating in 1 of 5 randomized controlled trials. METHOD Structural equation modeling and latent growth curve modeling were used to evaluate the relationship between frequency of cocaine use within treatment (8 or 12 weeks) and a latent construct of global problems indicated by the days of problems reported on the Addiction Severity Index across follow-up time points (1, 3, 6, and 12 months after treatment). RESULTS Both a continuous latent cocaine use outcome measure (percent days abstinent, percent positive urines, and maximum days of consecutive abstinence) and a dichotomous measure of cocaine use (≥21 consecutive days of abstinence) during the treatment period were associated with frequency of cocaine use and global problems during follow-up. Overall, results indicated that greater cocaine abstinence during the treatment period was associated with higher rates of abstinence and fewer global problems experienced following treatment. CONCLUSION This is one of the first studies to support a model that suggests addiction-related problems decrease in accordance with achieving abstinence from cocaine, thereby providing evidence that within-treatment cocaine abstinence has benefits that extend beyond the frequency of drug use.