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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA027533-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The primary aim of this research study (STEP) is to compare the effectiveness of two smoking cessation programs that integrate counseling and nicotine replacement with either a wellness program or exercise. This will help us to determine whether different lifestyle interventions (wellness or exercise) help increase the effectiveness of current standard programs for smoking cessation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care plus Wellness Program | Active Comparator |
| |
| Standard Care plus Exercise Program | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Treatment | Behavioral | Cognitive Behavioral Treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day | Point Prevalence Abstinence (PPA) was defined as not smoking [even a single puff] at the end of treatment and/or on the day of follow-up | End of treatment (10 weeks post quit day) and 30-week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jasper Smits, PhD | Southern Methodist University | Principal Investigator |
| Michael Zvolensky, PhD | University of Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Methodist University | Dallas | Texas | 75206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20171786 | Background | Tart CD, Leyro TM, Richter A, Zvolensky MJ, Rosenfield D, Smits JA. Negative affect as a mediator of the relationship between vigorous-intensity exercise and smoking. Addict Behav. 2010 Jun;35(6):580-5. doi: 10.1016/j.addbeh.2010.01.009. Epub 2010 Feb 1. | |
| 20434171 | Background | Smits JA, Rosenfield D, Mather AA, Tart CD, Henriksen C, Sareen J. Psychotropic medication use mediates the relationship between mood and anxiety disorders and obesity: findings from a nationally representative sample. J Psychiatr Res. 2010 Nov;44(15):1010-6. doi: 10.1016/j.jpsychires.2010.04.007. |
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Of the 150 enrolled participants, 7 participants completed a baseline assessment, then subsequently dropped out of the study before receiving any treatment. 7 participants were used as pilots. Accordingly, results are reported for the remaining 136 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care Plus Wellness Program | Cognitive Behavioral Treatment: Cognitive Behavioral Treatment Nicotine Patch: Nicotine Patch Wellness Program: Wellness Program consisting of thrice weekly sessions involving discussion of various wellness topics (e.g., diet, sun care, cancer prevention) and generating small wellness-related goals |
| FG001 | Standard Care Plus Exercise Program | Cognitive Behavioral Treatment: Cognitive Behavioral Treatment Nicotine Patch: Nicotine Patch Aerobic Exercise: Aerobic Exercise thrice weekly (on a treadmill) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care Plus Wellness Program | Cognitive Behavioral Treatment: Cognitive Behavioral Treatment Nicotine Patch: Nicotine Patch Wellness Program: Wellness Program |
| BG001 | Standard Care Plus Exercise Program |
| 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 | Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day | Point Prevalence Abstinence (PPA) was defined as not smoking [even a single puff] at the end of treatment and/or on the day of follow-up | Participants who completed the end of treatment assessment | Posted | Number | number of participants | End of treatment (10 weeks post quit day) and 30-week follow-up |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Care Plus Wellness Program | Cognitive Behavioral Treatment: Cognitive Behavioral Treatment Nicotine Patch: Nicotine Patch Wellness Program: Wellness Program |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malignant melanoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jasper Smits | The University of Texas at Austin | 512-475-8095 | smits@utexas.edu |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D006293 | Health Promotion |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
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| Nicotine Patch | Drug | Nicotine Patch |
|
| Wellness Program | Behavioral | Wellness Program |
|
| Aerobic Exercise | Behavioral | Aerobic Exercise |
|
| 21111538 | Background | Medina JL, Vujanovic AA, Smits JA, Irons JG, Zvolensky MJ, Bonn-Miller MO. Exercise and coping-oriented alcohol use among a trauma-exposed sample. Addict Behav. 2011 Mar;36(3):274-7. doi: 10.1016/j.addbeh.2010.11.008. Epub 2010 Nov 10. |
| 21314753 | Background | Smits JA, Bonn-Miller MO, Tart CD, Irons JG, Zvolensky MJ. Anxiety sensitivity as a mediator of the relationship between moderate-intensity exercise and coping-oriented marijuana use motives. Am J Addict. 2011 Mar-Apr;20(2):113-9. doi: 10.1111/j.1521-0391.2010.00115.x. Epub 2011 Feb 1. |
| 21700713 | Background | Smits JA, Tart CD, Rosenfield D, Zvolensky MJ. The interplay between physical activity and anxiety sensitivity in fearful responding to carbon dioxide challenge. Psychosom Med. 2011 Jul-Aug;73(6):498-503. doi: 10.1097/PSY.0b013e3182223b28. Epub 2011 Jun 23. |
| 21915160 | Background | Mathew AR, Norton PJ, Zvolensky MJ, Buckner JD, Smits JA. Smoking Behavior and Alcohol Consumption in Individuals With Panic Attacks. J Cogn Psychother. 2011 Feb 1;25(1):61-70. doi: 10.1891/0889-8391.25.1.61. |
| 21857769 | Background | Zvolensky MJ, Buckner JD, Norton PJ, Smits JA. Anxiety, Substance Use, and Their Co-Occurrence: Advances in Clinical Science. J Cogn Psychother. 2011;25(1):3-6. doi: 10.1891/0889-8391.25.1.3. |
| 22664396 | Background | Deboer LB, Tart CD, Presnell KE, Powers MB, Baldwin AS, Smits JA. Physical activity as a moderator of the association between anxiety sensitivity and binge eating. Eat Behav. 2012 Aug;13(3):194-201. doi: 10.1016/j.eatbeh.2012.01.009. Epub 2012 Jan 28. |
| 26513517 | Derived | Smits JA, Zvolensky MJ, Davis ML, Rosenfield D, Marcus BH, Church TS, Powers MB, Frierson GM, Otto MW, Hopkins LB, Brown RA, Baird SO. The Efficacy of Vigorous-Intensity Exercise as an Aid to Smoking Cessation in Adults With High Anxiety Sensitivity: A Randomized Controlled Trial. Psychosom Med. 2016 Apr;78(3):354-64. doi: 10.1097/PSY.0000000000000264. |
| 23148822 | Derived | Smits JA, Zvolensky MJ, Rosenfield D, Marcus BH, Church TS, Frierson GM, Powers MB, Otto MW, Davis ML, DeBoer LB, Briceno NF. The efficacy of vigorous-intensity exercise as an aid to smoking cessation in adults with elevated anxiety sensitivity: study protocol for a randomized controlled trial. Trials. 2012 Nov 13;13:207. doi: 10.1186/1745-6215-13-207. |
Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Aerobic Exercise: Aerobic Exercise
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ASI-3 | Throughout treatment and follow-up, we assessed Anxiety Sensitivity using the Anxiety Sensitivity Index-3 (ASI-3). Recent research has supported using a cut-off score of 23 to identify high AS individuals with this instrument. ASI was assessed via self-report online prior to each assessment visit. ASI scores range from 0 to 72. Lower anxiety sensitivity scores in this study are indicative of better outcomes. | Mean | Standard Deviation | units on a scale |
|
|
|
| 1 |
| 64 |
| 0 |
| 64 |
| EG001 | Standard Care Plus Exercise Program | Cognitive Behavioral Treatment: Cognitive Behavioral Treatment Nicotine Patch: Nicotine Patch Aerobic Exercise: Aerobic Exercise | 1 | 72 | 0 | 72 |
| Vertebrae fractures | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not obtained during study sessions; deemed unrelated to study procedures |
|
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| D005159 |
| Health Care Facilities Workforce and Services |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |