Development of Positive Psychotherapy for Smoking Cessation

Study Overview
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Brief Summary
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The primary objective of this study is to test a manualized adaptation of positive psychotherapy (PPT) for smoking cessation (PPT-S). The investigators will conduct a preliminary randomized clinical trial (N = 80) to examine the feasibility, acceptability, and efficacy of PPT-S over 26 weeks of follow up in comparison to a standard smoking cessation treatment. Both treatments will be delivered in individual 6 sessions over 6 weeks, and will include provision of transdermal nicotine patch. The effect size estimates from this Stage 1b research will provide the foundation for a future application to conduct a large-scale, Stage II, randomized clinical trial.

Official Title
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Development of Positive Psychotherapy for Smoking Cessation

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: Positive Psychotherapy for smoking cessation
* Drug: Nicotine polacrilex
* Behavioral: Relaxation training
* Behavioral: Behavioral smoking cessation treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: smoke at least 5 cigarettes per day for longer than one year with no other ongoing tobacco product use willing to use the transdermal nicotine patch report at least a 5 on a 0 to 10 scale rating the importance of quitting smoking. Exclusion Criteria: are currently experiencing psychotic symptoms, affective disorder (major depression, dysthymia, or mania) or substance use disorder (other than nicotine dependence) taking prescribed psychotropic medication or receiving other forms of psychotherapy concomitantly using other pharmacotherapies for smoking cessation have any contraindications for use of the transdermal nicotine patch.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive psychotherapy<br>6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch. | Behavioral: Positive Psychotherapy for smoking cessation<br>* 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.<br>Drug: Nicotine polacrilex<br>* 8 weeks of nicotine patch<br>Behavioral: Behavioral smoking cessation treatment<br>* Counseling on techniques to manage triggers and avoid smoking<br>|
| Active Comparator: Standard treatment<br>6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition | Drug: Nicotine polacrilex<br>* 8 weeks of nicotine patch<br>Behavioral: Relaxation training<br>* Instructions in progressive muscle relaxation<br>Behavioral: Behavioral smoking cessation treatment<br>* Counseling on techniques to manage triggers and avoid smoking<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day Point Prevalence Smoking Abstinence at 8 Weeks | Biochemically verified abstinence from smoking over the past 7 days | 8 weeks | 
| 7-day Point Prevalence Smoking Abstinence at 16 Weeks | Biochemically verified abstinence from smoking over the past 7 days | 16 Weeks | 
| 7-day Point Prevalence Smoking Abstinence at 26 Weeks | Biochemically verified abstinence from smoking over the past 7 days | 26 Weeks | 

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