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Self-help materials for the prevention of smoking relapse: study protocol for a randomized controlled trial
Fujian Song1, Richard Holland, Garry R Barton
1Norwich Medical School, Faculty of Medicine and Health Science, University of East Anglia, Norwich NR4 7TJ, UK. Fujian.song@uea.ac.uk
Trials
|June 1, 2012
Summary
Self-help booklets may help prevent smoking relapse. This randomized controlled trial evaluated their effectiveness and cost-effectiveness in the National Health Service Stop Smoking Service, with results to be published.
Area of Science:
- Public Health
- Behavioral Science
- Clinical Trials
Background:
- Smoking relapse is common, with few effective interventions.
- Self-help materials show potential for relapse prevention.
- This study evaluates educational materials within the NHS Stop Smoking Service.
Purpose of the Study:
- To assess the effectiveness of self-help educational materials in preventing smoking relapse.
- To determine the cost-effectiveness of these materials.
- To provide evidence for routine clinical practice in smoking cessation services.
Main Methods:
- An open, randomized controlled trial with 1,400 participants.
- Intervention: Revised 'Forever Free' self-help booklets.
- Control: Standard NHS leaflet. Outcomes measured at 3 and 12 months via CO tests and questionnaires.
Main Results:
- Primary outcome: Prolonged abstinence from months 4-12 (CO confirmed).
- Secondary outcomes: Point prevalence abstinence at 3 and 12 months.
- Cost-effectiveness analysis using EQ-5D for Quality Adjusted Life Year (QALY) gain.
Conclusions:
- Self-help educational materials have significant public health implications for smoking relapse prevention.
- Findings will inform the routine implementation of interventions in smoking cessation services.
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