Hypnosis for Smoking Relapse Prevention (HypnoRelapse)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00770380|
Recruitment Status : Completed
First Posted : October 10, 2008
Last Update Posted : October 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Smoking||Behavioral: behavioral relapse prevention counseling Other: hypnosis for relapse prevention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||139 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hypnosis for Smoking Relapse Prevention|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||June 2011|
Experimental: Hypnosis for relapse prevention
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.
Other: hypnosis for relapse prevention
Hypnosis for relapse prevention conducted in two one-hour sessions
Other Name: hypnotherapy
Active Comparator: Behavioral relapse prevention counseling
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: behavioral relapse prevention counseling
Behavioral relapse prevention counseling conducted in two one-hour sessions
Other Name: relapse prevention
- Point prevalence smoking status at 9, 26 and 52 weeks [ Time Frame: one year ]Point prevalence smoking status during past 7 days
- continuous quitting as measured by reported non-smoking at 9, 26 and 52 weeks continuously [ Time Frame: one year ]Reported continuous abstinence from smoking
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|