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

Nicole F Briceno¹  Lindsey B DeBoer¹  Michelle L Davis¹  Michael W Otto⁶  Mark B Powers¹  Georita M Frierson²  Timothy S Church⁵  Bess H Marcus³  David Rosenfield¹  Michael J Zvolensky⁴  Jasper A J Smits¹ 

[1] Department of Psychology, Southern Methodist University, Dedman College, P.O. Box 750442, Dallas, TX, 75275, USA;Department of Psychology, Howard University, Washington, DC, USA;Department of Family & Preventive Medicine, University of California, San Diego, CA, USA;Department of Psychology, University of Houston, Houston, TX, USA;Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA;Department of Psychology, Boston University, Boston, MA, USA

关键词: Anxiety sensitivity;    Anxiety;    Aerobic exercise;    Exercise;    Randomized controlled trial;    Intervention;    Smoking cessation;    Smoking;   

Others  :  1095212
DOI  :  10.1186/1745-6215-13-207

 received in 2012-09-28, accepted in 2012-10-30,  发布年份 2012

【 摘 要 】

Background

Although cigarette smoking is a leading cause of death and disability in the United States (US), over 40 million adults in the US currently smoke. Quitting smoking is particularly difficult for smokers with certain types of psychological vulnerability. Researchers have frequently called attention to the relation between smoking and anxiety-related states and disorders, and evidence suggests that panic and related anxiety vulnerability factors, specifically anxiety sensitivity (AS or fear of somatic arousal), negatively impact cessation. Accordingly, there is merit to targeting AS among smokers to improve cessation outcome. Aerobic exercise has emerged as a promising aid for smoking cessation for this high-risk (for relapse) group because exercise can effectively reduce AS and other factors predicting smoking relapse (for example, withdrawal, depressed mood, anxiety), and it has shown initial efficacy for smoking cessation. The current manuscript presents the rationale, study design and procedures,and design considerations of the Smoking Termination Enhancement Project (STEP).

Methods

STEP is a randomized clinical trial that compares a vigorous-intensity exercise intervention to a health and wellness education intervention as an aid for smoking cessation in adults with elevated AS. One hundred and fifty eligible participants will receive standard treatment (ST) for smoking cessation that includes cognitive behavioral therapy (CBT) and nicotine replacement therapy (NRT). In addition, participants will be randomly assigned to either an exercise intervention (ST+EX) or a health and wellness education intervention (ST+CTRL). Participants in both arms will meet 3 times a week for 15 weeks, receiving CBT once a week for the first 7 weeks, and 3 supervised exercise or health and wellness education sessions (depending on randomization) per week for the full 15-week intervention. Participants will be asked to set a quit date for 6 weeks after the baseline visit, and smoking cessation outcomes as well as putative mediator variables will be measured up to 6 months following the quit date.

Discussion

The primary objective of STEP is to evaluate whether vigorous-intensity exercise can aid smoking cessation in anxiety vulnerable adults. If effective, the use of vigorous-intensity exercise as a component of smoking cessation interventions would have a significant public health impact. Specifically, in addition to improving smoking cessation treatment outcome, exercise is expected to offer benefits to overall health, which may be particularly important for smokers. The study is also designed to test putative mediators of the intervention effects and therefore has the potential to advance the understanding of exercise-anxiety-smoking relations and guide future research on this topic.

Clinical trials registry

ClinicalTrials.gov, NCT01065506, http://clinicaltrials.gov/ct2/show/NCT01065506 webcite

【 授权许可】

   
2012 Smits et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

【 参考文献 】

• [1]U.S. Department of Health and Human Services: Health, United States, 2004 with Chartbook on Trends in the Health of Americans. Hyattsville, MD: U.S. Government Printing Office; 2004.
• [2]U.S. Department of Health and Human Services: Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Public Health Service; 2008.
• [3]Samet JM: Health benefits of smoking cessation. Clin Chest Med 1991, 12:669-679.
• [4]Centers for Disease Control and Prevention: Tobacco use among adults - United States, 2005. MMWR Morb Mortal Wkly Rep 2006, 55:1145-1148.
• [5]Centers for Disease Control and Prevention: Cigarette smoking among adults: United States, 2000. MMWR Morb Mortal Wkly Rep 2002, 51:642-645.
• [6]Garvey AJ, Heinold JW, Rosner B: Self-help approaches to smoking cessation: a report from the normative aging study. Addict Behav 1989, 14:23-33.
• [7]Brown RA, Emmons KM: Behavioral treatment of cigarette dependence. In The Clinical Management of Nicotine Dependence. Edited by Cocores JA. New York, NY: Springer; 1991:97-118.
• [8]Schwartz DA: Review and Evaluation of Smoking Cessation Methods: The United States and Canada. Bethesda, MD: National Cancer Institute; 1987.
• [9]Irvin JE, Brandon TH: The increasing recalcitrance of smokers in clinical trials. Nicotine Tob Res 2000, 2:79-84.
• [10]Piasecki TM, Baker TB: Any further progress in smoking cessation treatment? Nicotine Tob Res 2001, 3:311-323.
• [11]Shiffman S: Smoking cessation treatment: any progress? J Consult Clin Psychol 1993, 61:718-722.
• [12]Coambs RB, Kozlowski L, Ferrence RG: The future of tobacco use and smoking research. In Smoking and Human Behavior. Edited by Nay T, Gale A. New York, NY: Wiley; 1989:337-348.
• [13]Hughes JR: Pharmacotherapy for smoking cessation: unvalidated assumptions, anomalies, and suggestions for future research. J Consult Clin Psychol 1993, 61:751-760.
• [14]Hughes JR, Brandon TH: A softer view of hardening. Nicotine Tob Res 2003, 5:961-962.
• [15]Ziedonis D, Hitsman B, Beckham JC, Zvolensky M, Adler LE, Audrain-McGovern J, Breslau N, Brown RA, George TP, Williams J, Calhoun PS, Riley WT: Tobacco use and cessation in psychiatric disorders: National Institute of Mental Health report. Nicotine Tob Res 2008, 10:1691-1715.
• [16]Lasser K, Boyd JW, Woolhandler S, Himmelstein DU, McCormick D, Bor DH: Smoking and mental illness: a population-based prevalence study. JAMA 2000, 284:2606-2610.
• [17]Acierno R, Kilpatrick DG, Resnick H, Saunders B, De Arellano M, Best C: Assault, PTSD, family substance use, and depression as risk factors for cigarette use in youth: findings from the National Survey of Adolescents. J Trauma Stress 2000, 13:381-396.
• [18]Acierno RA, Kilpatrick DG, Resnick HS, Saunders BE, Best CL: Violent assault, posttraumatic stress disorder, and depression. Risk factors for cigarette use among adult women. Behav Modif 1996, 20:363-384.
• [19]Buckley TC, Mozley SL, Bedard MA, Dewulf AC, Greif J: Preventive health behaviors, health-risk behaviors, physical morbidity, and health-related role functioning impairment in veterans with post-traumatic stress disorder. Mil Med 2004, 169:536-540.
• [20]Dobie DJ, Kivlahan DR, Maynard C, Bush KR, Davis TM, Bradley KA: Posttraumatic stress disorder in female veterans: association with self-reported health problems and functional impairment. Arch Intern Med 2004, 164:394-400.
• [21]Zvolensky MJ, Schmidt NB, Stewart SH: Panic disorder and smoking. Clin Psychol Sci Pract 2003, 10:29-51.
• [22]Zvolensky M, Bernstein A, Yartz AR: Cognitive-behavioral treatment of co-morbid panic psychopathology and tobacco use and dependence. Anxiety Substance Use Disorders 2008, 177-200.
• [23]Hapke U, Schumann A, Rumpf HJ, John U, Konerding U, Meyer C: Association of smoking and nicotine dependence with trauma and posttraumatic stress disorder in a general population sample. J Nerv Ment Dis 2005, 193:843-846.
• [24]Piper ME, Smith SS, Schlam TR, Fleming MF, Bittrich AA, Brown JL, Leitzke CJ, Zehner ME, Fiore MC, Baker TB: Psychiatric disorders in smokers seeking treatment for tobacco dependence: relations with tobacco dependence and cessation. J Consult Clin Psychol 2010, 78:13-23.
• [25]Reiss S, Peterson RA, Gursky DM, McNally RJ: Anxiety sensitivity, anxiety frequency and the prediction of fearfulness. Behav Res Ther 1986, 24:1-8.
• [26]Hayward C, Wilson KA: Anxiety sensitivity: a missing piece to the agoraphobia-without-panic puzzle. Behav Modif 2007, 31:162-173.
• [27]Li W, Zinbarg RE: Anxiety sensitivity and panic attacks: a 1-year longitudinal study. Behav Modif 2007, 31:145-161.
• [28]Marshall GN, Miles JN, Stewart SH: Anxiety sensitivity and PTSD symptom severity are reciprocally related: evidence from a longitudinal study of physical trauma survivors. J Abnorm Psychol 2010, 119:143-150.
• [29]Schmidt NB, Keough ME, Mitchell MA, Reynolds EK, Macpherson L, Zvolensky MJ, Lejuez CW: Anxiety sensitivity: prospective prediction of anxiety among early adolescents. J Anxiety Disord 2010, 24:503-508.
• [30]Schmidt NB, Lerew DR, Jackson RJ: The role of anxiety sensitivity in the pathogenesis of panic: prospective evaluation of spontaneous panic attacks during acute stress. J Abnorm Psychol 1997, 106:355-364.
• [31]Schmidt NB, Lerew DR, Jackson RJ: Prospective evaluation of anxiety sensitivity in the pathogenesis of panic: replication and extension. J Abnorm Psychol 1999, 108:532-537.
• [32]Schmidt NB, Zvolensky MJ, Maner JK: Anxiety sensitivity: prospective prediction of panic attacks and Axis I pathology. J Psychiatr Res 2006, 40:691-699.
• [33]Maller R, Reiss S: Anxiety sensitivity in 1984 and panic attacks in 1987. J Anxiety Disord 1992, 6:241-247.
• [34]Battista SR, Stewart SH, Fulton HG, Steeves D, Darredeau C, Gavric D: A further investigation of the relations of anxiety sensitivity to smoking motives. Addict Behav 2008, 33:1402-1408.
• [35]Comeau N, Stewart SH, Loba P: The relations of trait anxiety, anxiety sensitivity, and sensation seeking to adolescents’ motivations for alcohol, cigarette, and marijuana use. Addict Behav 2001, 26:803-825.
• [36]Leyro TM, Zvolensky MJ, Vujanovic AA, Bernstein A: Anxiety sensitivity and smoking motives and outcome expectancies among adult daily smokers: replication and extension. Nicotine Tob Res 2008, 10:985-994.
• [37]Novak A, Burgess ES, Clark M, Zvolensky MJ, Brown RA: Anxiety sensitivity, self-reported motives for alcohol and nicotine use, and level of consumption. J Anxiety Disord 2003, 17:165-180.
• [38]Stewart SH, Karp J, Pihl RO, Peterson RA: Anxiety sensitivity and self-reported reasons for drug use. J Subst Abuse 1997, 9:223-240.
• [39]Zvolensky MJ, Bonn-Miller MO, Bernstein A, McLeish AC, Feldner MT, Leen-Feldner EW: Anxiety sensitivity interacts with marijuana use in the prediction of anxiety symptoms and panic-related catastrophic thinking among daily tobacco users. Behav Res Ther 2006, 44:907-924.
• [40]Brown RA, Kahler CW, Zvolensky MJ, Lejuez CW, Ramsey SE: Anxiety sensitivity: relationship to negative affect smoking and smoking cessation in smokers with past major depressive disorder. Addict Behav 2001, 26:887-899.
• [41]Gregor KL, Zvolensky MJ, McLeish AC, Bernstein A, Morissette S: Anxiety sensitivity and perceived control over anxiety-related events: associations with smoking outcome expectancies and perceived cessation barriers among daily smokers. Nicotine Tob Res 2008, 10:627-635.
• [42]Zvolensky MJ, Vujanovic AA, Miller MO, Bernstein A, Yartz AR, Gregor KL, McLeish AC, Marshall EC, Gibson LE: Incremental validity of anxiety sensitivity in terms of motivation to quit, reasons for quitting, and barriers to quitting among community-recruited daily smokers. Nicotine Tob Res 2007, 9:965-975.
• [43]Zvolensky MJ, Baker KM, Leen-Feldner E, Bonn-Miller MO, Feldner MT, Brown RA: Anxiety sensitivity: association with intensity of retrospectively-rated smoking-related withdrawal symptoms and motivation to quit. Cogn Behav Ther 2004, 33:114-125.
• [44]Johnson KA, Stewart S, Rosenfield D, Steeves D, Zvolensky MJ: Prospective evaluation of the effects of anxiety sensitivity and state anxiety in predicting acute nicotine withdrawal symptoms during smoking cessation. Psychol Addict Behav 2012, 26:289-297.
• [45]Mullane JC, Stewart SH, Rhyno E, Steeves D, Darredeau C, Gavric D: Anxiety, sensitivity and difficulties with smoking cessation. In Advances in Psychological Research, Volume 3. Edited by Columbus FH. New York, NY: Nova; 2008:141-155.
• [46]Vujanovic AA, Zvolenksy MJ: Anxiety sensitivity, acute nicotine withdrawal symptoms, and anxious and fearful responding to bodily sensations: A laboratory test. Exp Clin Psychopharmacol 2009, 17:3-181.
• [47]Wong M, Krajisnik A, Truong L, Lisha N, Trujillow M, Greenberg JB, Kahler CW, Zvolensky MJ, Leventhal AM: Anxiety sensitivity as a predictor of acute subjective effects of smoking. Nicotine Tob Resin press
• [48]Zvolensky MJ, Bernstein A: Cigarette smoking and panic psychopathology. Curr Dir Psychol Sci 2005, 14:301-305.
• [49]Zvolensky MJ, Bernstein A, Cardenas SJ, Colotla VA, Marshall EC, Feldner MT: Anxiety sensitivity and early relapse to smoking: a test among Mexican daily, low-level smokers. Nicotine Tob Res 2007, 9:483-491.
• [50]Zvolensky MJ, Stewart SH, Vujanovic AA, Gavric D, Steeves D: Anxiety sensitivity and anxiety and depressive symptoms in the prediction of early smoking lapse and relapse during smoking cessation treatment. Nicotine Tob Res 2009, 11:323-331.
• [51]Zvolensky MJ, Bonn-Miller MO, Feldner MT, Leen-Feldner E, McLeish AC, Gregor K: Anxiety sensitivity: Concurrent associations with negative affect smoking motives and abstinence self-confidence among young adult smokers. Addict Behav 2006, 31:429-439.
• [52]Zvolensky MJ, Kotov R, Antipova AV, Schmidt NB: Cross cultural evaluation of smokers risk for panic and anxiety pathology: a test in a Russian epidemiological sample. Behav Res Ther 2003, 41:1199-1215.
• [53]Broman-Fulks JJ, Berman ME, Rabian BA, Webster MJ: Effects of aerobic exercise on anxiety sensitivity. Behav Res Ther 2004, 42:125-136.
• [54]Smits JA, Berry AC, Rosenfield D, Powers MB, Behar E, Otto MW: Reducing anxiety sensitivity with exercise. Depress Anxiety 2008, 25:689-699.
• [55]Smits JAJ, Powers MB, Berry AC, Otto MW: Translating empirically supported strategies into accessible interventions. The potential utility of exercise for the treatment of panic disorder. Cogn Behv Pract 2007, 14:344-374.
• [56]Bock BC, Marcus BH, King TK, Borrelli B, Roberts MR: Exercise effects on withdrawal and mood among women attempting smoking cessation. Addict Behav 1999, 24:399-410.
• [57]Ussher MH, Taylor A, Faulkner G: Exercise interventions for smoking cessation. Cochrane Database Syst Rev 2008., (4) CD002295
• [58]Stathopoulou G, Powers MB, Berry AC, Smits JAJ, Otto MW: Exercise interventions for mental health: a quantitative and qualitative review. Clin Psychol Sci Pract 2006, 13:179-193.
• [59]DeBoer LB, Powers MB, Utschig AC, Otto MW, Smits JA: Exploring exercise as an avenue for the treatment of anxiety disorders. Expert Rev Neurother 2012, 12:1011-1022.
• [60]Marcus BH, Albrecht AE, King TK, Parisi AF, Pinto BM, Roberts M, Niaura RS, Abrams DB: The efficacy of exercise as an aid for smoking cessation in women: a randomized controlled trial. Arch Intern Med 1999, 159:1229-1234.
• [61]Schmidt NB, Joiner TE: Structure of the anxiety sensitivity index psychometrics and factor structure in a community sample. J Anxiety Disord 2002, 16:33-49.
• [62]Jarvis MJ, Tunstall-Pedoe H, Feyerabend C, Vesey C, Saloojee Y: Comparison of tests used to distinguish smokers from nonsmokers. Am J Public Health 1987, 77:1435-1438.
• [63]Zvolensky M, Yartz A, Gregor K, Gonzalez A, Bernstein A: Interoceptive exposure-based cessation intervention for smokers high in anxiety sensitivity: A case series. J Cogn Psychother 2008, 22:346-365.
• [64]Wolpe J: Psychotherapy by Recipricol Inhibition. Stanford, CA: Stanford University Press; 1958.
• [65]Borg G, Ljunggren G, Ceci R: The increase of perceived exertion, aches and pain in the legs, heart rate and blood lactate during exercise on a bicycle ergometer. Eur J Appl Physiol Occup Physiol 1985, 54:343-349.
• [66]Marcus BH, Lewis BA, Hogan J, King TK, Albrecht AE, Bock B, Parisi AF, Niaura R, Abrams DB: The efficacy of moderate-intensity exercise as an aid for smoking cessation in women: a randomized controlled trial. Nicotine Tob Res 2005, 7:871-880.
• [67]Shumaker SA, Grunberg NE: Proceedings of the national working conference on smoking relapse. Health Psychol 1986, 5:1-17.
• [68]Peterson CA: A psychotic gynemimetic: I just had a pregnant thought. J Pers Assess 1992, 58:464-479.
• [69]Zinbarg RE, Mohlman J, Hong NN: Dimensions of anxiety sensitivity. In Anxiety Sensitivity: Theory, Research and Treatment of the Fear of Anxiety. Edited by Taylor S. Hillsdale, NJ: Lawrence Earlbaum Associates; 1999:83-114.
• [70]Posner K, Oquendo MA, Gould M, Stanley B, Davies M: Columbia classification algorithm of suicide assessment (C-CASA): classification of suicidal events in the FDA’s pediatric suicidal risk analysis of antidepressants. Am J Psychiatry 2007, 164:1035-1043.
• [71]Hammad TA, Laughren TP, Racoosin JA: Suicide rates in short-term randomized controlled trials of newer antidepressants. J Clin Psychopharmacol 2006, 26:203-207.
• [72]First MB, Pincus HA, Levine JB, Williams JB, Ustun B, Peele R: Clinical utility as a criterion for revising psychiatric diagnoses. Am J Psychiatry 2004, 161:946-954.
• [73]Okin PM, Ameisen O, Kligfield P: A modified treadmill exercise protocol for computer-assisted analysis of the ST segment/heart rate slope: methods and reproducibility. J Electrocardiol 1986, 19:311-318.
• [74]Proceedings of the national working conference on smoking relapse. July 24–26, Bethesda, Maryland Health Psychol 1985, 1-99.
• [75]Sobell M, Sobell L: Problem Drinkers: Guided Self-Change Treatment. New York, NY: Guilford Press; 1996.
• [76]McLeish AC, Zvolensky MJ, Bucossi MM: Interaction between smoking rate and anxiety sensitivity: relation to anticipatory anxiety and panic-relevant avoidance among daily smokers. J Anxiety Disord 2007, 21:849-859.
• [77]Hughes JR, Hatsukami D: Signs and symptoms of tobacco withdrawal. Arch Gen Psychiatry 1986, 43:289-294.
• [78]Piasecki TM, Niaura R, Shadel WG, Abrams D, Goldstein M, Fiore MC, Baker TB: Smoking withdrawal dynamics in unaided quitters. J Abnorm Psychol 2000, 109:74-86.
• [79]Taylor S, Zvolensky MJ, Cox BJ, Deacon B, Heimberg RG, Ledley DR, Abramowitz JS, Holaway RM, Sandin B, Stewart SH, Coles M, Eng W, Daly ES, Arrindell WA, Bouvard M, Cardenas SJ: Robust dimensions of anxiety sensitivity: development and initial validation of the Anxiety Sensitivity Index-3. Psychol Assess 2007, 19:176-188.
• [80]Taylor S, Cox BJ: An expanded anxiety sensitivity index: evidence for a hierarchic structure in a clinical sample. J Anxiety Disord 1998, 12:463-483.
• [81]Watson D, O'Hara MW, Simms LJ, Kotov R, Chmielewski M, McDade-Montez EA, Gamez W, Stuart S: Development and validation of the inventory of depression and anxiety symptoms (IDAS). Psychol Assess 2007, 19:253-268.
• [82]Devilly GJ, Borkovec TD: Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry 2000, 31:73-86.
• [83]Hall SM, Delucchi KL, Velicer WF, Kahler CW, Ranger-Moore J, Hedeker D: Statistical analysis of randomized trials in tobacco treatment: longitudinal designs with dichotomous outcome. Nicotine Tob Res 2001, 3:193-202.
• [84]Singer JD, Willet JD: Applied Longitudinal Data Analysis: Modeling Change and Event Occurrence. New York, NY: Oxford University Press; 2003.
• [85]Mackinnon DP, Lockwood CM, Williams J: Confidence limits for the indirect effect: distribution of the product and resampling methods. Multivariate Behav Res 2004, 39:99.
• [86]Tein JY, Sandler IN, MacKinnon DP, Wolchik SA: How did it work? Who did it work for? Mediation in the context of a moderated prevention effect for children of divorce. J Consult Clin Psychol 2004, 72:617-624.
• [87]Aiken B, West SG: Multiple Regression: Testing and Interpreting Interactions. Thousand Oaks, CA: Sage; 1991.
• [88]Enders CK: Missing not at random models for latent growth curve analyses. Psychol Methods 2011, 16:1-16.
• [89]Fiore MC: US public health service clinical practice guideline: treating tobacco use and dependence. Respir Care 2000, 45:1200-1262.
• [90]Fiore MC, Jaen CR: A clinical blueprint to accelerate the elimination of tobacco use. JAMA 2008, 299:2083-2085.
• [91]Fiore MC, Smith SS, Jorenby DE, Baker TB: The effectiveness of the nicotine patch for smoking cessation. A meta-analysis. JAMA 1994, 271:1940-1947.
• [92]Barlow DH, Gorman JM, Shear MK, Woods SW: Cognitive-behavioral therapy, imipramine, or their combination for panic disorder: a randomized controlled trial. JAMA 2000, 283:2529-2536.
• [93]Schmidt NB, Woolaway-Bickel K: The effects of treatment compliance on outcome in cognitive-behavioral therapy for panic disorder: quality versus quantity. J Consult Clin Psychol 2000, 68:13-18.
• [94]Smits JA, Powers MB, Cho Y, Telch MJ: Mechanism of change in cognitive-behavioral treatment of panic disorder: evidence for the fear of fear mediational hypothesis. J Consult Clin Psychol 2004, 72:646-652.
• [95]Pate RR, Pratt M, Blair SN: Physical activity and public health: a recommendation from the Centers for Disease Control and Prevention and the American College of Sports Medicine. JAMA 1995, 273:402-407.