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Tobacco dependence counseling in a randomized multisite clinical trial.

Pharmacotherapy trials for treating tobacco dependence would benefit from behavioral interventions providing treatment consistent with clinical practice guidelines but not directing participants to treatments 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. We utilized this intervention manual in a multicenter, randomized clinical trial of smokers with attention deficit hyperactivity disorder. In this study, we evaluated how the interventional manual performed in a "train-the-trainer" model requiring uniform counseling across 6 sites and 15 interventionists. We analyzed the skill-adherence of the interventionists and the intervention-adherence of the participants. The 255 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. 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 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.

Pubmed ID: 22406192

Authors

  • Croghan IT
  • Trautman JA
  • Winhusen T
  • Ebbert JO
  • Kropp FB
  • Schroeder DR
  • Hurt RD

Journal

Contemporary clinical trials

Publication Data

July 28, 2012

Associated Grants

  • Agency: NIDA NIH HHS, Id: K24 DA022288
  • Agency: NIDA NIH HHS, Id: U10 DA013732-01
  • Agency: NIDA NIH HHS, Id: U10 DA013732-02
  • Agency: NIDA NIH HHS, Id: U10 DA013732-03
  • Agency: NIDA NIH HHS, Id: U10 DA013732-03S1
  • Agency: NIDA NIH HHS, Id: U10 DA013732-03S2
  • Agency: NIDA NIH HHS, Id: U10 DA013732-03S3
  • Agency: NIDA NIH HHS, Id: U10 DA013732-04
  • Agency: NIDA NIH HHS, Id: U10 DA013732-05
  • Agency: NIDA NIH HHS, Id: U10 DA013732-05S1
  • Agency: NIDA NIH HHS, Id: U10 DA013732-05S2
  • Agency: NIDA NIH HHS, Id: U10 DA013732-06
  • Agency: NIDA NIH HHS, Id: U10 DA013732-06S1
  • Agency: NIDA NIH HHS, Id: U10 DA013732-06S2
  • Agency: NIDA NIH HHS, Id: U10 DA013732-07
  • Agency: NIDA NIH HHS, Id: U10 DA013732-07S1
  • Agency: NIDA NIH HHS, Id: U10 DA015831
  • Agency: NIDA NIH HHS, Id: U10-DA013035
  • Agency: NIDA NIH HHS, Id: U10-DA013036
  • Agency: NIDA NIH HHS, Id: U10-DA013046
  • Agency: NIDA NIH HHS, Id: U10-DA013732
  • Agency: NIDA NIH HHS, Id: U10-DA015831

Mesh Terms

  • Combined Modality Therapy
  • Directive Counseling
  • Guideline Adherence
  • Humans
  • Manuals as Topic
  • Patient Compliance
  • Patient Education as Topic
  • Practice Guidelines as Topic
  • Smoking Cessation
  • Tobacco Use Disorder