Optimized Chronic Care for Smokers: A Comparative Effectiveness Approach; Motivation Project: Testing Intervention Components for the Smoker Who is Unwilling to Quit

NCT02354872 Phase 4 COMPLETED

The ultimate goal of this research is to develop a chronic care treatment package for smokers that will address the challenges and opportunities of each phase of the cessation process - motivation, preparation, cessation, maintenance, and relapse recovery. That is, to develop treatments for smokers not yet ready to quit, those who are preparing to quit, those actively engaged in the quitting process and those who have tried to quit but relapsed. To achieve this goal, this research comprises three distinct research studies, each of which represent a phase in a comprehensive chronic care treatment model for clinical intervention with smokers in the primary care setting: the Motivation Study, the Cessation Study, and the Long-term Quitting Study. The goal of each study is to test and identify effective intervention components for distinct phases of the smoking cessation process. These components will then be combined for future research on the effectiveness of this chronic care treatment package. This study is a 2x2x2x2 factorial design. Participants will be randomized to one of two levels on four different factors: 1) Nicotine Mini-Lozenge vs. No Mini-Lozenge, 2) Behavioral Reduction Counseling (intervention: BR) vs. No Behavioral Reduction Counseling, 3) 5Rs Motivation Counseling (intervention 5 R's) vs. No 5Rs Motivation Counseling, and 4) Behavioral Activation Counseling (intervention BA) vs. No Behavioral Activation Counseling. These components have strong theoretical and empirical support, but their relative, additive, and interactive effects are unknown.

Details

Lead sponsor	University of Wisconsin, Madison
Phase	Phase 4
Status	COMPLETED
Enrolment	577
Start date	2015-01
Completion	2019-03-19

Conditions

• Smoking
• Motivation
• Smoking Cessation

Interventions

• Nicotine Mini-Lozenge
• Behavioral Reduction Counseling
• 5Rs Motivation Counseling
• Behavioral Activation Counseling
• No Treatment

Primary outcomes

• 7-Day Point-Prevalence Abstinence — 12 months
  Participants who self-report no smoking for the past 7 days at the assessment endpoint (12 month follow-up) will be considered to meet criteria for 7-Day Point-Prevalence Abstinence. Participants who who report any smoking in the past 7 days (at the 12 month follow-up) will be considered to be relapsed (smoking).

Countries

United States