Development of Positive Psychotherapy for Smoking Cessation

Brown University

Status and phase: Completed; Phase 2

Conditions: Smoking

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01451814

NCI-156241-1

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

Positive psychotherapy

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral smoking cessation treatment

Drug: Nicotine polacrilex

Behavioral: Positive Psychotherapy for smoking cessation

Standard treatment

Active Comparator group

Description:

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

Treatment:

Behavioral: Relaxation training

Behavioral: Behavioral smoking cessation treatment

Drug: Nicotine polacrilex