TY - JOUR
T1 - Design and methodological considerations of an effectiveness trial of a computer-assisted intervention
T2 - An example from the NIDA Clinical Trials Network
AU - Campbell, Aimee N.C.
AU - Nunes, Edward V.
AU - Miele, Gloria M.
AU - Matthews, Abigail
AU - Polsky, Daniel
AU - Ghitza, Udi E.
AU - Turrigiano, Eva
AU - Bailey, Genie L.
AU - VanVeldhuisen, Paul
AU - Chapdelaine, Rita
AU - Froias, Autumn
AU - Stitzer, Maxine L.
AU - Carroll, Kathleen M.
AU - Winhusen, Theresa
AU - Clingerman, Sara
AU - Perez, Livangelie
AU - McClure, Erin
AU - Goldman, Bruce
AU - Crowell, A. Rebecca
N1 - Funding Information:
Dr. Genie Bailey has been on the speaker's bureau of Forest Pharmaceuticals and Pfizer and has received research support from Titan Pharmaceuticals, Inc. and Alkermes, Inc.
Funding Information:
This work was supported by grants from the National Drug Abuse Treatment Clinical Trials Network (CTN) , National Institute on Drug Abuse (NIDA) : U10 DA13035 (Edward V. Nunes and John Rotrosen), U10 DA015831 (Kathleen M. Carroll and Roger D. Weiss), U10 DA013034 (Maxine L. Stitzer and Robert P. Schwartz), U10 DA013732 (Eugene C. Somoza), U10 DA013720 (José Szapocznik and Lisa R. Metsch), and K24 DA022412 (Edward V. Nunes). Staff from NIDA's Center for the Clinical Trials Network collaborated in the design of the study, contributed to writing this manuscript, and provided editorial comments.
PY - 2012/3
Y1 - 2012/3
N2 - Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments. Reviews of research on computer-assisted treatments for mental health and substance abuse report promising findings, but study quality and methodological limitations remain an issue. In addition, relatively few computer-assisted treatments have been tested among illicit substance users. This manuscript describes the methodological considerations of a multi-site effectiveness trial conducted within the National Institute on Drug Abuse's (NIDA's) National Drug Abuse Treatment Clinical Trials Network (CTN). The study is evaluating a web-based version of the Community Reinforcement Approach, in addition to prize-based contingency management, among 500 participants enrolled in 10 outpatient substance abuse treatment programs. Several potential effectiveness trial designs were considered and the rationale for the choice of design in this study is described. The study uses a randomized controlled design (with independent treatment arm allocation), intention-to-treat primary outcome analysis, biological markers for the primary outcome of abstinence, long-term follow-up assessments, precise measurement of intervention dose, and a cost-effectiveness analysis. Input from community providers during protocol development highlighted potential concerns and helped to address issues of practicality and feasibility. Collaboration between providers and investigators supports the utility of infrastructures that enhance research partnerships to facilitate effectiveness trials and dissemination of promising, technologically innovative treatments. Outcomes from this study will further the empirical knowledge base on the effectiveness and cost-effectiveness of computer-assisted treatment in clinical treatment settings.
AB - Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments. Reviews of research on computer-assisted treatments for mental health and substance abuse report promising findings, but study quality and methodological limitations remain an issue. In addition, relatively few computer-assisted treatments have been tested among illicit substance users. This manuscript describes the methodological considerations of a multi-site effectiveness trial conducted within the National Institute on Drug Abuse's (NIDA's) National Drug Abuse Treatment Clinical Trials Network (CTN). The study is evaluating a web-based version of the Community Reinforcement Approach, in addition to prize-based contingency management, among 500 participants enrolled in 10 outpatient substance abuse treatment programs. Several potential effectiveness trial designs were considered and the rationale for the choice of design in this study is described. The study uses a randomized controlled design (with independent treatment arm allocation), intention-to-treat primary outcome analysis, biological markers for the primary outcome of abstinence, long-term follow-up assessments, precise measurement of intervention dose, and a cost-effectiveness analysis. Input from community providers during protocol development highlighted potential concerns and helped to address issues of practicality and feasibility. Collaboration between providers and investigators supports the utility of infrastructures that enhance research partnerships to facilitate effectiveness trials and dissemination of promising, technologically innovative treatments. Outcomes from this study will further the empirical knowledge base on the effectiveness and cost-effectiveness of computer-assisted treatment in clinical treatment settings.
KW - Clinical trial design
KW - Computer-assisted treatment
KW - Effectiveness research
KW - Randomized trials
KW - Substance use disorders
UR - http://www.scopus.com/inward/record.url?scp=84856233537&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84856233537&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2011.11.001
DO - 10.1016/j.cct.2011.11.001
M3 - Article
C2 - 22085803
AN - SCOPUS:84856233537
SN - 1551-7144
VL - 33
SP - 386
EP - 395
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
IS - 2
ER -