Hypnosis for Smoking Relapse Prevention

Study Overview
=================
Brief Summary
-----------------
A majority of smokers who quit return to smoking within three months of their quit date. This study is a randomized trial to investigate the effectiveness of hypnosis versus behavioural counseling to promote maintenance of abstinence or relapse prevention in quitting smokers. The hypothesis is that hypnosis will be at least as effective as behavioral counseling in preventing relapse to smoking in smokers who are able to quit for at least three days.

Detailed Description
-----------------
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.

Official Title
-----------------
Hypnosis for Smoking Relapse Prevention

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Behavioral: behavioral relapse prevention counseling
* Other: hypnosis for relapse prevention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: currently smoking at least 5/cigarettes per day during the past week willingness to participate and give informed consent aged 18 and above Exclusion Criteria: contraindications to nicotine replacement pregnancy, lactation unstable psychiatric disorders current (last 3 months)substance use disorder terminal illness current use of smoking cessation medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis for relapse prevention<br>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<br>* Hypnosis for relapse prevention conducted in two one-hour sessions<br>* Other names: hypnotherapy;|
| Active Comparator: Behavioral relapse prevention counseling<br>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<br>* Behavioral relapse prevention counseling conducted in two one-hour sessions<br>* Other names: relapse prevention;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point prevalence smoking status at 9, 26 and 52 weeks | Point prevalence smoking status during past 7 days | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| continuous quitting as measured by reported non-smoking at 9, 26 and 52 weeks continuously | Reported continuous abstinence from smoking | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking