Phase 2
Completed N=66
Development of Positive Psychotherapy for Smoking Cessation
Source: ClinicalTrials.gov NCT01451814 ↗Enrolled (actual)
66
Serious AEs
1.5%
Results posted
Mar 2015
Primary outcomePrimary: 7-day Point Prevalence Smoking Abstinence at 8 Weeks — 40.0; 25.8 percentage of participants abstinent — p=.22
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7-day Point Prevalence Smoking Abstinence at 8 Weeks |
40.0; 25.8 | .22 |
| PRIMARY 7-day Point Prevalence Smoking Abstinence at 16 Weeks |
22.9; 6.5 | .06 |
| PRIMARY 7-day Point Prevalence Smoking Abstinence at 26 Weeks |
17.1; 6.5 | .18 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01451814). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.