Development of Positive Psychotherapy for Smoking Cessation

Phase 2

Completed

Conditions: Smoking

Interventions: Behavioral: Positive Psychotherapy for smoking cessation
Drug: Nicotine polacrilex
Behavioral: Relaxation training
Behavioral: Behavioral smoking cessation treatment

Registration Number: NCT01451814

Lead Sponsor: Brown University

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 66

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive psychotherapy	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.
Positive psychotherapy	Behavioral smoking cessation treatment	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.
Standard treatment	Nicotine polacrilex	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
Standard treatment	Behavioral smoking cessation 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
Standard treatment	Relaxation training	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
Positive psychotherapy	Nicotine polacrilex	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.

Primary Outcome Measures

Name	Time	Method
7-day Point Prevalence Smoking Abstinence at 8 Weeks	8 weeks	Biochemically verified abstinence from smoking over the past 7 days
7-day Point Prevalence Smoking Abstinence at 16 Weeks	16 Weeks	Biochemically verified abstinence from smoking over the past 7 days
7-day Point Prevalence Smoking Abstinence at 26 Weeks	26 Weeks	Biochemically verified abstinence from smoking over the past 7 days