Hypnosis for Smoking Relapse Prevention (HypnoRelapse)
|Smoking||Behavioral: behavior relapse prevention counseling Other: hypnosis||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Hypnosis for Smoking Relapse Prevention|
- Point prevalence smoking status at 9, 26 and 52 weeks [ Time Frame: one year ]
- continuous quitting as measured by reported non-smoking at 9, 26 and 52 weeks continuously [ Time Frame: one year ]
|Study Start Date:||June 2007|
|Study Completion Date:||June 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
The hypnosis intervention was conducted in two face-to-face visits with hypnosis recorded for home practice. Learning, practicing, and employing hypnotic skills in resisting the urge to smoke are core components of this intervention.
two one-hour sessions
Other Name: hypnotherapy
Active Comparator: 2
In the behavioral relapse prevention counseling, participants were taught coping strategies for resisting the urge to smoke. This intervention focused on relapse prevention (i.e., maintenance stage of change) and was based on the theoretical concepts and treatment procedures advocated by Marlatt and Gordon and recent smoking relapse data.
Behavioral: behavior relapse prevention counseling
two one-hour sessions
Other Name: relapse prevention
We will enroll 520 current smokers in the study. All subjects will participate in an initial smoking cessation intervention involving brief counseling and nicotine replacement therapy. Participants who are able to achieve at least 3 consecutive days of abstinence will be randomized to one of two relapse prevention interventions. The participants in Study Arm 1 will receive a hypnosis intervention designed to facilitate relapse prevention. Participants in Study Arm 2 will participate in empirically-supported behavior relapse prevention counseling, utilizing the National Cancer Institute's Forever Free materials. Both interventions will be conducted in two 60-minute individual sessions scheduled one week apart in addition to counseling phone calls on their quit date and after relapse prevention treatment.
Outcomes for the two study arms will be compared by assessing biochemically-validated point-prevalence smoking status at 9 weeks(end of treatment), 26 weeks and 52 weeks. Hypnosis for relapse prevention is designed to sustain the ex-smokers commitment to remain abstinent, to provide a review of behavioral skills to resist the temptations to smoke, and to encourage attempts to quit again if relapse occurs.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770380
|United States, California|
|Veterans Affairs Medical Center, 4150 Clement Street|
|San Francisco, California, United States, 94121|
|Principal Investigator:||Timothy P Carmody, PhD||University of California, San Francisco|