Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive psychotherapy | Experimental | 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 | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Psychotherapy for smoking cessation | 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. |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Alcohol and Addiction Studies, Brown University | Providence | Rhode Island | 02912 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25646352 | Result | Kahler CW, Spillane NS, Day AM, Cioe PA, Parks A, Leventhal AM, Brown RA. Positive Psychotherapy for Smoking Cessation: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2015 Nov;17(11):1385-92. doi: 10.1093/ntr/ntv011. Epub 2015 Feb 2. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. Nicotine polacrilex: 8 weeks of nicotine patch Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking |
| FG001 | 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 Nicotine polacrilex: 8 weeks of nicotine patch Relaxation training: Instructions in progressive muscle relaxation Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants fully eligible and attending the first session of counseling
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. Nicotine polacrilex: 8 weeks of nicotine patch Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 7-day Point Prevalence Smoking Abstinence at 8 Weeks | Biochemically verified abstinence from smoking over the past 7 days | Posted | Number | percentage of participants abstinent | 8 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. Nicotine polacrilex: 8 weeks of nicotine patch Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Kahler | Brown University School of Public Health | 401 863-6651 | Christopher_Kahler@brown.edu |
Not provided
| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D012064 | Relaxation Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D001521 | Behavior Therapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Nicotine polacrilex | Drug | 8 weeks of nicotine patch |
|
| Relaxation training | Behavioral | Instructions in progressive muscle relaxation |
|
| Behavioral smoking cessation treatment | Behavioral | Counseling on techniques to manage triggers and avoid smoking |
|
| BG001 | 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 Nicotine polacrilex: 8 weeks of nicotine patch Relaxation training: Instructions in progressive muscle relaxation Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fagstrom Test for Nicotine Dependence | Score ranges from 0 to 10 with higher scores indicating greater dependence. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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 Nicotine polacrilex: 8 weeks of nicotine patch Relaxation training: Instructions in progressive muscle relaxation Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking |
|
|
|
| Primary | 7-day Point Prevalence Smoking Abstinence at 16 Weeks | Biochemically verified abstinence from smoking over the past 7 days | Posted | Number | percentage of participants abstinent | 16 Weeks |
|
|
|
|
| Primary | 7-day Point Prevalence Smoking Abstinence at 26 Weeks | Biochemically verified abstinence from smoking over the past 7 days | Posted | Number | percentage of participants abstinent | 26 Weeks |
|
|
|
|
| 1 |
| 35 |
| 0 |
| 35 |
| EG001 | 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 Nicotine polacrilex: 8 weeks of nicotine patch Relaxation training: Instructions in progressive muscle relaxation Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking | 0 | 31 | 0 | 31 |
Not provided
Not provided
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |