Smoking Termination Enhancement Project (STEP)
STEP
2 other identifiers
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2009
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 8, 2010
CompletedFirst Posted
Study publicly available on registry
February 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
February 4, 2016
CompletedFebruary 4, 2016
January 1, 2016
3.9 years
February 8, 2010
November 20, 2015
January 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Standard Care plus Wellness Program
ACTIVE COMPARATORStandard Care plus Exercise Program
ACTIVE COMPARATORInterventions
Cognitive Behavioral Treatment
Nicotine Patch
Eligibility Criteria
You may qualify if:
- Aged between 18 and 65 years old
- Capable of providing informed consent, attend all study visits and comply with the protocol
- Daily smoker for at least one year and currently smoke an average of at least 10 cigarettes per day
- Report a motivation to quit smoking in the next month of at least 5 on a 10-point scale
- Score of 20 or greater on 16-item Anxiety Sensitivity Index
- Physically inactive as defined as participating in moderate-intensity exercise less than 2 days/week (duration must be 30 minutes or less each time)
You may not qualify if:
- Use of other tobacco products
- General medical condition(s) that contraindicate exercise
- Resting blood pressure of ≥ 160 systolic and/or 100 diastolic who are not receiving treatment for high blood pressure
- Blood lipid levels ≥ 240 mg/dl with LDL-C ≥ 160 mg/dl or triglyceride levels ≥ 300 mg/dl (individuals receiving medical treatment for lipid abnormalities with lipid levels above the cut-offs will be eligible with physician written approval)
- Body mass index ≥40
- Currently suicidal or high suicide risk
- Current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol
- Currently pregnant, planning on becoming pregnant in the next year, or current breastfeeding
- Alcohol or drug dependence; abuse of depressants, dissociative anesthetics, hallucinogens, opioids, or cocaine within the last 6 months
- Psychotherapy initiated within the past three months, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or mood disorder other than general supportive therapy
- Current use of any psychotherapy or pharmacotherapy for smoking cessation not provided by the researchers, including Chantix, Zyban, Welbutrin and Nortriptyline.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southern Methodist University
Dallas, Texas, 75206, United States
Related Publications (10)
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.
PMID: 20171786BACKGROUNDSmits 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.
PMID: 20434171BACKGROUNDMedina 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.
PMID: 21111538BACKGROUNDSmits 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.
PMID: 21314753BACKGROUNDSmits 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.
PMID: 21700713BACKGROUNDMathew 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.
PMID: 21915160BACKGROUNDZvolensky 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.
PMID: 21857769BACKGROUNDDeboer 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.
PMID: 22664396BACKGROUNDSmits 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.
PMID: 26513517DERIVEDSmits 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.
PMID: 23148822DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jasper Smits
- Organization
- The University of Texas at Austin
Study Officials
- PRINCIPAL INVESTIGATOR
Jasper Smits, PhD
Southern Methodist University
- PRINCIPAL INVESTIGATOR
Michael Zvolensky, PhD
University of Houston
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 8, 2010
First Posted
February 9, 2010
Study Start
September 1, 2009
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
February 4, 2016
Results First Posted
February 4, 2016
Record last verified: 2016-01