Design and methodological considerations of an effectiveness trial of a computer-assisted intervention: An example from the NIDA Clinical Trials Network

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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)386-395
Number of pages10
JournalContemporary Clinical Trials
Volume33
Issue number2
DOIs
StatePublished - Mar 2012

Keywords

  • Clinical trial design
  • Computer-assisted treatment
  • Effectiveness research
  • Randomized trials
  • Substance use disorders

ASJC Scopus subject areas

  • Pharmacology (medical)

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