Contemporary Clinical Trials 2012;33(4):576-582. [doi: 10.1016/j.cct.2012.02.014]
Ivana T. Croghan, PhD (Mayo Clinic, OV Node), Judith A. Trautman, RN (Mayo Clinic, OV Node), Theresa M. Winhusen, PhD (University of Cincinnati/CinARC, OV Node), Jon O. Ebbert, MD (Mayo Clinic, OV Node), Frankie B. Kropp, MS (University of Cincinnati/CinARC, OV Node), Darrell R. Schroeder, MS (Mayo Clinic, OV Node), Richard D. Hurt, MD (Mayo Clinic, OV Node).
Pharmacotherapy trials for treating tobacco dependence would benefit from behavioral interventions providing treatment consistent with clinical practice guidelines but not directing participants to treatment not evaluated in the trial. The Smoke Free and Living It behavioral intervention manual includes participant and interventionist guides and is designed to provide both practical counseling and intra-treatment support. In protocol CTN-0029, researchers utilized this intervention manual as part of their multicenter, randomized clinical trial of smokers with attention deficit hyperactivity disorder. In the study, they evaluated how the interventional manual performed in a "train-the-trainer" model requiring uniform counseling across 6 sites and 15 interventionists. The skill-adherence of the interventionists and the intervention-adherence of the participants was analyzed. The 2555 randomized participants completed 9.3 +/- 2.8 sessions (mean +/- SD), with 157 participants (61.6%) completing all 11 of the sessions and 221 (86.7%) completing at least 6 of the 11 sessions. Of the 163 sessions for which the study interventionists were evaluated, 156 (95.7%) were rated as adherent to protocol and "meeting expectations" on at least 6 of 7 established criteria, illustrating that fidelity can be maintained with minimal supervision.
Conclusions: The self-help and interventionists guides of the Smoke Free and Living It manual can thus be used to provide behavioral intervention with a high rate of adherence by both the interventionists and the participants. This manual can be used as a self-help guide, an interventionist guide, or both, and can be tailored to a specific research protocol, regardless of the size of the study or number of study sites. The Smoke Free and Living It manual meets the requirements of the United States Public Health Service Clinical Practice Guideline, can be adapted to specific research protocols, and provides a useful option for behavioral intervention during clinical trials for smoking cessation. (Article (Peer-Reviewed), PDF, English, 2012)
Keywords: Attention Deficit Hyperactivity Disorder (ADHD) | Behavior therapy | CTN platform/ancillary study | Fidelity of implementation | Smoking | Smoke Free and Living It manual | Contemporary Clinical Trials (journal)
Document No: 797, PMID: 22406192, PMCID: PMC3361527.
Submitted by CTN Dissemination Librarians, 3/8/2012.