Development of Positive Psychotherapy for Smoking Cessation

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-02-28

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.

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Detailed Description

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Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Positive psychotherapy

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.

Group Type EXPERIMENTAL

Positive Psychotherapy for smoking cessation

Intervention Type BEHAVIORAL

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.

Nicotine polacrilex

Intervention Type DRUG

8 weeks of nicotine patch

Behavioral smoking cessation treatment

Intervention Type BEHAVIORAL

Counseling on techniques to manage triggers and avoid smoking

Standard treatment

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

Group Type ACTIVE_COMPARATOR

Nicotine polacrilex

Intervention Type DRUG

8 weeks of nicotine patch

Relaxation training

Intervention Type BEHAVIORAL

Instructions in progressive muscle relaxation

Behavioral smoking cessation treatment

Intervention Type BEHAVIORAL

Counseling on techniques to manage triggers and avoid smoking

Interventions

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Positive Psychotherapy for smoking cessation

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.

Intervention Type BEHAVIORAL

Nicotine polacrilex

8 weeks of nicotine patch

Intervention Type DRUG

Relaxation training

Instructions in progressive muscle relaxation

Intervention Type BEHAVIORAL

Behavioral smoking cessation treatment

Counseling on techniques to manage triggers and avoid smoking

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes