Research Findings - CTN-Related Research
A Step Forward in Teaching Addiction Counselors How to Supervise Motivational Interviewing Using a Clinical Trials Training Approach
A clinical trials training approach to supervision is a promising and empirically supported method for preparing addiction counselors to implement evidence-based behavioral treatments in community treatment programs. This supervision approach has three main components: (1) direct observation of treatment sessions; (2) structured performance feedback about counselors' treatment adherence and competence; and (3) coaching to improve the ability of counselors to implement psychosocial treatments proficiently. This article describes how to teach addiction counselors this approach to supervision as it is applied to Motivational Interviewing (MI) using a clinical supervision procedure called Motivational Interviewing Assessment: Supervisory Tools for Enhancing Proficiency (MIA-STEP). MIA-STEP is one of the NIDA/SAMHSA Blending Team Products and was based on protocol CTN-0005 ("MI (Motivational Interviewing) to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse"), which found that MI improved both client attendance and retention during the first four weeks of outpatient care. The authors describe teaching points and strategies instructors may use to develop supervisory skills in each of the three main supervision components (performance observation, feedback, and coaching), how to supervise in an MI consistent manner, recommended qualifications for supervising MI, and future directions for MI supervision research. Martino, S., Gallon, S., Ball, S.A., and Carroll, K.M. Journal of Teaching in the Addictions. 6(2), pp. 39-67, 2008. [DOI: 10.1080/15332700802127946].
Community Program Therapist Adherence and Competence in Motivational Enhancement Therapy
The extent to which clinicians in addiction treatment programs can implement empirically validated therapies with adequate fidelity that can be discriminated from standard counseling has rarely been evaluated. The authors evaluated the treatment adherence and competence of 35 therapists from five outpatient community programs who delivered either a three-session adaptation of motivational enhancement therapy (MET) or an equivalent number of drug counseling-as-usual sessions to 461 clients within a National Institute on Drug Abuse Clinical Trial Network multi-site effectiveness protocol. MET therapists were carefully prepared to implement MET using a combination of expert-led intensive workshop training followed by program-based clinical supervision. Independent rating of sessions demonstrated that the adherence and competence items were very reliable (mean interclass correlation coefficients for adherence=.89 and competence=.81) and converged to form two a priori defined skill factors conceptually related to motivational interviewing. Moreover, the factors discriminated between MET therapists and those who delivered drug counseling-as-usual sessions in predicted ways, and were significantly related to in-session change in client motivation and some client treatment outcomes (percent negative drug urine screens). These findings demonstrate the reliability and validity of evaluating motivational interviewing fidelity and suggest that the combination of expert-led workshops followed by program-based clinical supervision may be an effective method for disseminating motivational interviewing in community treatment programs. Martino, S., Ball, S.A., Nich, C., Frankforter, T.L., and Carroll, K.M. Drug Alcohol Depend. 96(1-2), pp. 37-48, 2008. Epub 2008 March 6. PMID: 18328638 [PubMed - indexed for MEDLINE].
Quantifying Data Quality for Clinical Trials Using Electronic Data Capture
Historically, only partial assessments of data quality have been performed in clinical trials, for which the most common method of measuring database error rates has been to compare the case report form (CRF) to database entries and count discrepancies. Importantly, errors arising from medical record abstraction and transcription are rarely evaluated as part of such quality assessments. Electronic Data Capture (EDC) technology has had a further impact, as paper CRFs typically leveraged for quality measurement are not used in EDC processes. The National Institute on Drug Abuse Treatment Clinical Trials Network has developed, implemented, and evaluated methodology for holistically assessing data quality on EDC trials. The authors characterize the average source-to-database error rate (14.3 errors per 10,000 fields) for the first year of use of the new evaluation method. This error rate was significantly lower than the average of published error rates for source-to-database audits, and was similar to CRF-to-database error rates reported in the published literature. The authors attribute this largely to an absence of medical record abstraction on the trials they examined, and to an outpatient setting characterized by less acute patient conditions. Historically, medical record abstraction is the most significant source of error by an order of magnitude, and should be measured and managed during the course of clinical trials. Source-to-database error rates are highly dependent on the amount of structured data collection in the clinical setting and on the complexity of the medical record, dependencies that should be considered when developing data quality benchmarks. Nahm, M.L., Pieper, C.F., and Cunningham, M.M. PLoS ONE. 3(8), pp. e3049, 2008. PMID: 18725958 [PubMed - indexed for MEDLINE] PMCID: PMC2516178.
Effectiveness of HIV/STD Sexual Risk Reduction Groups for Women in Substance Abuse Treatment Programs: Results of NIDA Clinical Trials Network Trial
Because drug-involved women are among the fastest growing groups with AIDS, sexual risk reduction intervention for them is a public health imperative. The objective of this study was to test the effectiveness of HIV/STD safer sex skills building (SSB) groups for women in community drug treatment. The study design comprised a randomized trial of SSB versus standard HIV/STD Education (HE); assessments at baseline, 3 and 6 months. Women recruited from 12 methadone or psychosocial treatment programs in Clinical Trials Network of National Institute on Drug Abuse served as subjects. Five hundred fifteen women who reported unprotected vaginal or anal sex occasions (USO) with a male partner in the past 6 months were randomized. In SSB, five 90-minute groups used problem solving and skills rehearsal to increase HIV/STD risk awareness, condom use, and partner negotiation skills. In HE, one 60-minute group covered HIV/STD disease, testing, treatment, and prevention information. The study's main outcome was the number of USOs at follow-up. A significant difference in mean USOs was obtained between SSB and HE over time (F = 67.2, P < 0.0001). At 3 months, significant decrements were observed in both conditions. At 6 months, SSB maintained the decrease and HE returned to baseline (P < 0.0377). Women in SSB had 29% fewer USOs than those in HE. The authors concluded that skills building interventions can produce ongoing sexual risk reduction in women in community drug treatment. Tross, S., Campbell, A.N., Cohen, L.R., Calsyn, D., Pavlicova, M., Miele, G.M., Hu, M.C., Haynes, L., Nugent, N., Gan, W., Hatch-Maillette, M., Mandler, R., McLaughlin, P., El-Bassel, N., Crits-Christoph, P., and Nunes, E.V. J. Acquir. Immune Defic. Syndr., 48(5), pp. 581-589, 2008. PMID: 18645513 [PubMed - indexed for MEDLINE].
Assessment and Treatment of Co-occurring Eating Disorders in Publicly Funded Addiction Treatment Programs
Publicly funded addiction treatment programs were surveyed to increase understanding of treatment options for persons with co-occurring eating and substance use disorders. Data were collected between 2002 and 2004 from face-to-face interviews with program directors of a nationally representative sample of 351 addiction treatment programs. Half of the programs screen patients for eating disorders; 29% admit all persons with eating disorders, and 48% admit persons with eating disorders of low severity. Few programs attempt to treat eating disorders. Programs that admit and treat patients with eating disorders are more likely to emphasize a medical-psychiatric model of addiction, use psychiatric medications, admit patients with other psychiatric disorders, and have a lower caseload of African-American patients. The authors conclude that generally, patients with co-occurring eating and substance use disorders do not appear to receive structured assessment or treatment for eating disorders in addiction treatment programs. These results highlight the need for education of addiction treatment professionals in assessment of eating disorders. Gordon, S.M., Johnson, J.A,, Greenfield, S.F., Cohen, L., Killeen, T., and Roman, P.M. Psychiatr. Serv. 59(9), pp. 1056-1059, 2008. PMID: 18757602 [PubMed - indexed for MEDLINE].
Informal Discussions in Substance Abuse Treatment Sessions
This study evaluated the extent to which counselors initiated informal discussions (i.e., general discussions and self-disclosures about matters unrelated to treatment) with their clients during treatment sessions within two National Institute on Drug Abuse Clinical Trial Network protocols involving adaptations of motivational interviewing (MI). Sixty counselors across the two protocols had 736 sessions independently rated for counselor treatment fidelity and the occurrence of informal discussions. The results showed that 88% of the counselors initiated informal discussions in their sessions and that most of these discussions involved counselors sharing personal information or experiences they had in common with their clients. The major finding was that counselor training in MI was associated with significantly less informal discussion across sessions. A higher frequency of informal discussion was (1) related to lower counselor MI proficiency and less in-session change in client motivation, and (2) unrelated to client program retention and substance use outcomes. The findings suggest that although some informal discussions may help build an alliance between counselors and clients, too much of it may hinder both counselors' proficient implementation of MI treatment strategies and clients' motivational enhancement process. Martino, S., Ball, S.A., Nich, C., Frankforter, T.L., and Carroll, K.M. J. Subst. Abuse Treat. 2008 October 3. [Epub ahead of print] PMID: 18835679 [PubMed - as supplied by publisher].
Extended vs. Short-Term Buprenorphine-Naloxone for Treatment of Opioid-Addicted Youth: A Randomized Trial
The usual treatment for opioid-addicted youth is detoxification and counseling; however, extended medication-assisted therapy may be more helpful. To evaluate this question, the National Drug Abuse Treatment Clinical Trials Network study CTN-0010 evaluated the efficacy of continuing buprenorphine-naloxone for 12 weeks versus detoxification for opioid-addicted youth. The CTN-0010 clinical trial, held at six community treatment programs from July 2003 to December 2006, included 152 patients aged 15 to 21 years who were randomized to 12 weeks of buprenorphine-naloxone or a 14-day taper (detox). Patients in the 12-week buprenorphine/naloxone group were prescribed up to 24 mg per day for 9 weeks and then tapered to week 12; patients in the detox group were prescribed up to 14 mg a day and then tapered to day 14. All were offered weekly individual and group counseling. The main outcome measure was opioid-positive urine test results at weeks 4, 8, and 12. The number of patients younger than 18 years was too small to analyze separately, but overall, patients in the detox group had higher proportions of opioid-positive urine test results at weeks 4 and 8, but not at week 12. At week 4, 59 detox patients had positive results versus 58 12-week buprenorphine/naloxone patients. At week 8, 53 detox patients had positive results versus 52 12-week buprenorphine/naloxone patients. At week 12, 53 detox patients had positive results versus 49 12-week buprenorphine/naloxone patients. By week 12, 16 of 78 detox patients (20.5%) remained in treatment vs. 52 of 74 12-week buprenorphine/naloxone patients (70%). During weeks 1 through 12, patients in the 12-week buprenorphine/naloxone group reported less opioid use, less injecting, and less nonstudy addiction treatment. High levels of opioid use occurred in both groups at follow-up. Four of 83 patients who tested negative for hepatitis C at baseline were positive for hepatitis C at week 12. In conclusion, continuing treatment with buprenorphine/ naloxone improved outcome compared with short-term detoxification. Further research is necessary to assess the efficacy and safety of longer-term treatment with buprenorphine for young individuals with opioid dependence. Woody, G.E., Poole, S.A., Subramaniam, G., Dugosh, K., Bogenschutz, M., Abbott, P., Patkar, A., Publicker, M., McCain, K., Sharpe, P.J., Forman, R., Vetter, V., McNicholas, L., Blaine, J., Lynch, K.G., and Fudala, P. JAMA 300(17), pp. 2003-2011, 2008. PMID: 18984887 [PubMed - indexed for MEDLINE].
Serious Adverse Events in Randomized Psychosocial Treatment Studies: Safety or Arbitrary Edicts?
Human subjects protection policies developed for pharmaceutical trials are now being widely applied to psychosocial intervention studies. This study examined occurrences of serious adverse events (SAEs) reported in multicenter psychosocial trials of the National Institute on Drug Abuse Clinical Trials Network. Substance-abusing participants (N = 1,687) were randomized to standard care or standard care plus either contingency management or motivational enhancement. Twelve percent of participants experienced 1 or more SAEs during the 27,198 person-weeks of follow-up. Of the 260 SAEs recorded, none were judged by the data safety monitoring board to be study related, and there were no significant differences between experimental and control conditions in SAE incidence rates. These data underscore the need to reconsider the rationale behind, and appropriate methods for, monitoring safety during psychosocial therapy trials. Petry, N.M., Roll, J.M., Rounsaville, B.J., Ball, S.A., Stitzer, M., Peirce, J.M., Blaine, J., Kirby, K.C., McCarty, D., and Carroll, K.M. J. Consult. Clin. Psychol., 76(6), pp. 1076-1082, 2008. PMID: 19045975 [PubMed - in process].
Predictors of Outcome for Short-term Medically Supervised Opioid Withdrawal During a Randomized, Multicenter Trial of Buprenorphine-naloxone and Clonidine in the NIDA Clinical Trials Network Drug and Alcohol Dependence
Few studies in community settings have evaluated predictors, mediators, and moderators of treatment success for medically supervised opioid withdrawal treatment. This report presents new findings about these factors from a study of 344 opioid-dependent men and women prospectively randomized to either buprenorphine-naloxone or clonidine in an open-label 13-day medically supervised withdrawal study. Subjects were either inpatient or outpatient in community treatment settings; however not randomized by treatment setting. Medication type (buprenorphine-naloxone versus clonidine) was the single best predictor of treatment retention and treatment success, regardless of treatment setting. Compared to the outpatient setting, the inpatient setting was associated with higher abstinence rates but similar retention rates when adjusting for medication type. Early opioid withdrawal severity mediated the relationship between medication type and treatment outcome with buprenorphine-naloxone being superior to clonidine at relieving early withdrawal symptoms. Inpatient subjects on clonidine with lower withdrawal scores at baseline did better than those with higher withdrawal scores; inpatient subjects receiving buprenorphine-naloxone did better with higher withdrawal scores at baseline than those with lower withdrawal scores. No relationship was found between treatment outcome and age, gender, race, education, employment, marital status, legal problems, baseline depression, or length/severity of drug use. Tobacco use was associated with worse opioid treatment outcomes. Severe baseline anxiety symptoms doubled treatment success. Medication type (buprenorphine-naloxone) was the most important predictor of positive outcome; however the paper also considers other clinical and policy implications of other results, including that inpatient setting predicted better outcomes and moderated medication outcomes. Ziedonis, D.M., Amass, L., Steinberg, M., Woody, G., Krejci, J., Annon, J.J., Cohen, A.J., Waite-O'Brien, N., Stine, S.M., McCarty, D., Reid, M.S., Brown, L.S. Jr., Maslansky, R., Winhusen, T., Babcock, D., Brigham, G., Muir, J., Orr, D., Buchan, B.J., Horton, T., and Ling, W. Drug Alcohol Depend. 99(1-3), pp. 28-36, 2009. Epub 2008 September 20.
What is Usual about "Treatment-as-Usual"? Data from Two Multisite Effectiveness Trials
Despite increased emphasis on broadening the implementation of empirically-supported therapies (ESTs) to improve standard clinical practice and patient outcomes, objective descriptions of what actually constitutes standard practice in community-based drug abuse treatment do not exist. The authors evaluated independent ratings of 379 audiotapes drawn from the "treatment-as-usual" arm of two multisite randomized effectiveness trials in the National Institute on Drug Abuse Clinical Trials Network. Fifteen independent tape raters were trained to assess clinician adherence and competence, and were blind to treatment protocol. The most frequently occurring strategies involved assessing the participant's substance use and social functioning, asking open-ended questions, discussing problems and feedback, and giving advice and direction. However, a number of interventions associated with ESTs were very rarely implemented in these early sessions. These data suggest missed opportunities for optimally engaging patients in the early stages of treatment and enhancing substance use outcomes and only moderate success to date of efforts to bridge the gap between research and practice. Santa Ana, E.J., Martino, S., Ball, S.A., Nich, C., Frankforter, T.L., and Carroll, K.M. What is Usual about "Treatment-as-Usual"? Data from Two Multisite Effectiveness Trials. Journal of Substance Abuse Treatment, 35(4), pp. 369-379, 2008.