title: Design and methodological considerations of an effectiveness trial of a computer-assisted intervention: an example from the NIDA Clinical Trials Network.
abstract: 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.
authors.affiliation: New York State Psychiatric Institute, Department of Psychiatry, Columbia University College of Physicians and Surgeons, 1051 Riverside Drive, New York, NY 10032, United States. anc2002@columbia.edu
authors.forename: Aimee N C
authors.initials: AN
authors.lastname: Campbell
authors.forename: Edward V
authors.initials: EV
authors.lastname: Nunes
authors.forename: Gloria M
authors.initials: GM
authors.lastname: Miele
authors.forename: Abigail
authors.initials: A
authors.lastname: Matthews
authors.forename: Daniel
authors.initials: D
authors.lastname: Polsky
authors.forename: Udi E
authors.initials: UE
authors.lastname: Ghitza
authors.forename: Eva
authors.initials: E
authors.lastname: Turrigiano
authors.forename: Genie L
authors.initials: GL
authors.lastname: Bailey
authors.forename: Paul
authors.initials: P
authors.lastname: VanVeldhuisen
authors.forename: Rita
authors.initials: R
authors.lastname: Chapdelaine
authors.forename: Autumn
authors.initials: A
authors.lastname: Froias
authors.forename: Maxine L
authors.initials: ML
authors.lastname: Stitzer
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Carroll
authors.forename: Theresa
authors.initials: T
authors.lastname: Winhusen
authors.forename: Sara
authors.initials: S
authors.lastname: Clingerman
authors.forename: Livangelie
authors.initials: L
authors.lastname: Perez
authors.forename: Erin
authors.initials: E
authors.lastname: McClure
authors.forename: Bruce
authors.initials: B
authors.lastname: Goldman
authors.forename: A Rebecca
authors.initials: AR
authors.lastname: Crowell
mesh_terms: D002985:Clinical Protocols / Q000592:standards*; D003153:Community Health Services / Q000191:economics / Q000379:methods*; D003194:Computer-Assisted Instruction / Q000379:methods*; D003362:Cost-Benefit Analysis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D054577:National Institute on Drug Abuse (U.S.); D011785:Quality Assurance, Health Care / Q000458:organization & administration*; D012107:Research Design; D019966:Substance-Related Disorders / Q000191:economics / Q000534:rehabilitation*; D014481:United States
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