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Design and Methodological Considerations of an Effectiveness Trial of a Computer-Assisted Intervention: An Example from the NIDA Clinical Trials Network.

Contemporary Clinical Trials 2012;33(2):386-395. [doi: 10.1016/j.cct.2011.11.001]

Aimee N. C. Campbell, MSW, PhD (New York State Psychiatric Institute, GNY Node), Edward V. Nunes, MD (New York State Psychiatric Institute, GNY Node), Gloria M. Miele, PhD (New York State Psychiatric Institute, GNY Node), Abigail Matthews, PhD (EMMES Corporation, DSC), Daniel Polsky, PhD (University of Pennsylvania School of Medicine, DV Node), Udi E. Ghitza, PhD (Center for the Clinical Trials Network, NIDA), Eva Turrigiano, MS (New York State Psychiatric Institute, GNY Node), Genie L. Bailey, MD (Stanley Street Treatment and Resources, NEC Node), Paul VanVeldhuisen, PhD (EMMES Corporation, DSC), Rita Chapdelaine, MSW (Stanley Street Treatment and Resources, NEC Node), Autumn Froias (Stanley Street Treatment and Resources, NEC Node), Maxine L. Stitzer, PhD (Johns Hopkins University School of Medicine, MA Node), Kathleen M. Carroll, PhD (Yale University School of Medicine, NEC Node), Theresa M. Winhusen, PhD (University of Cincinnati/CinARC, OV Node), Sara Clingerman (The Center for Drug Free Living, Inc, FNA Node), Livangelie Perez (The Center for Drug Free Living, Inc, FNA Node), Erin McClure, PhD (Johns Hopkins University School of Medicine, MA Node), Bruce Goldman, LCSW, CASAC (North Shore-Long Island Jewish Health System, GNY Node), A. Rebecca Crowell, MEd, LCDC (Nexus Recovery Center, TX Node).

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 (protocol CTN-0044). 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. (Article (Peer-Reviewed), PDF, English, 2011)

Keywords: Behavior therapy | Community health services | Contingency management (CM) | Cost-effectiveness | CTN protocol development | Internet counseling | Motivational incentives | Research design | Therapeutic Education System (TES) | Contemporary Clinical Trials (journal)

Document No: 775, PMID: 22085803, PMCID: PMC3268951.

Submitted by CTN Dissemination Librarians, 11/10/2011.

Bailey, Genie L. search mail
Campbell, Aimee N. C. search mail
Carroll, Kathleen M. search mail
Chapdelaine, Rita search
Clingerman, Sara search mail
Crowell, A. Rebecca search mail
Froias, Autumn search
Ghitza, Udi E. search mail
Goldman, Bruce search mail
Matthews, Abigail search mail
McClure, Erin search mail
Miele, Gloria M. search mail
Nunes, Edward V. search mail
Perez, Livangelie search mail
Polsky, Daniel search mail
Stitzer, Maxine L. search mail
Turrigiano, Eva search mail
VanVeldhuisen, Paul search mail
Winhusen, Theresa M. search mail
NIDA-CTN-0044 search www
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