Exercise for depressed women smokers_MS

Supervised, Vigorous Intensity Exercise Intervention for Depressed Female Smokers: A Pilot Study Christi A Patten, PhD,a Carrie Bronars, PhD,a Kristin Vickers Douglas, PhD,a Michael Ussher, PhD,b James Levine, MD, PhD,c Susannah J Tye, PhD,e Christine Hughes,a Tabetha A Brockman,a Paul Decker, MS,d Ramona DeJesus, MD,a Mark Williams, MD,a Thomas Olson, PhD,a Matthew M Clark, PhD,a and Angie Dieteriche a Mayo Clinic, Department of Psychiatry and Psychology, 200 First Street SW, Rochester, Minnesota 55905, United States b Population Health Research Institute, St George’s University of London, London SW71 ORE, United Kingdom c Mayo Clinic, 13400 East Shea Boulevard, Scottsdale, Arizona 85259, United States d Mayo Clinic, Department of Health Sciences Research, 200 First Street SW, Rochester, Minnesota 55905, United States e Rochester Area Family YMCA, 709 First Avenue, Rochester, Minnesota 55902, United States Corresponding Author: Christi A Patten, PhD, Department of Psychiatry and Psychology, Mayo Clinic, 200 First Street SW, Rochester, Minnesota 55905, United States Telephone: 507-538-7370; Fax: 507-266-2478; E-mail: patten.christi@mayo.edu Clinical Trials Registration: NCT01860924 Text word count: 3,480 Tables: Figures: Supplemental Material: intervention manual Abstract Introduction Few studies have evaluated exercise interventions for smokers with depression or other psychiatric comorbidities This pilot study evaluated the potential role of supervised vigorous exercise as a smoking cessation intervention for depressed females Methods Thirty adult women with moderate-severe depressive symptoms were enrolled and randomly assigned to 12 weeks of thrice weekly, in person sessions of vigorous intensity supervised exercise at a YMCA setting (EX; n=15) or health education (HE; n=15) All participants received behavioral smoking cessation counseling and nicotine patch therapy Assessments were done in person at baseline, at the end of 12 weeks of treatment, and at months post target-quit-date Primary endpoints were exercise adherence (proportion of 36 sessions attended) and biochemically confirmed 7-day point prevalence abstinence at Week 12 Biomarkers of inflammation were explored for differences between treatment groups and between women continuing to smoke and those who quit at Week 12 Results Treatment adherence was high for both groups (66% for HE and 72% for EX; p=0.55) The week 123 smoking abstinence rate was higher for EX than HE (11/15 [73%] vs 5/15 [33%]; p=0.028), but no significant differences emerged at 6-month follow-up Interlukin (IL6) levels increased more for smokers compared with those abstinent at Week 12 (p=0.040) Conclusions Vigorous intensity supervised exercise is feasible and enhances smoking cessation among depressed female smokers Innovative and cost-effective strategies to bolster long-term exercise adherence and smoking cessation need evaluation in this population Inflammatory biomarkers could be examined in future research as mediators of treatment efficacy Implications This preliminary study found that vigorous intensity supervised exercise is feasible and enhances smoking cessation among depressed female smokers This research addressed an important gap in the field Despite decades of research examining exercise interventions for smoking cessation, few studies were done among depressed smokers or those with comorbid psychiatric disorders A novel finding was increases in levels of a pro-inflammatory biomarker observed among women who continued to smoke after the intervention compared to those who did not Introduction In 2014, the prevalence of cigarette smoking among United States women was 14.8%.1 Women have lower quit rates than men.2,3 Also, women smokers tend to have higher levels of depression than non-smokers4 and smokers with elevated depressive symptoms have poorer smoking treatment outcomes.5-7 Thus, designing effective smoking cessation interventions for women with depression – a tobacco use disparity group – is a public health priority.8,9 Few studies have targeted smokers with current depression and, aside from our pilot study, 10 none of these targeted women specifically.11-15 This pilot study evaluated the potential role of supervised vigorous exercise as a smoking cessation intervention for depressed females A recent Cochrane review of 20 randomized trials concluded there was little evidence that exercise was effective as a smoking cessation intervention.16 These trials were limited by small sample sizes, inadequate control groups, interventions of insufficient exercise intensity, and a lack of support being provided to ensure adherence to the exercise intervention The only trial to show a long-term effect on smoking abstinence targeted women using 12-weeks of thrice weekly, supervised vigorous intensity exercise;17 an intervention also effective for treating depression.18 When this treatment was translated to a community YMCA setting and streamlined to four supervised exercise sessions, it was not effective for smoking cessation and there was poor adherence to exercise.19 Similarly, two studies of exercise counseling encouraging homebased exercise for depressed smokers found no effect on smoking abstinence compared with a health education contact control group.10,11 A supervised exercise program has the potential to benefit depressed smokers by providing reinforcement, guidance, and support for exercise; thus improving adherence.16 In this study we piloted the feasibility, acceptability and potential efficacy of a supervised, vigorous intensity exercise intervention for smoking cessation in a community YMCA setting among depressed females An exploratory aim was to examine potential biological impact of treatment response, through assessment of the intervention (exercise), and smoking cessation outcome on biomarkers of inflammation Methods The study was approved by the Mayo Clinic Institutional Review Board, and registered with clinicaltrials.gov (NCT01860924) Data were collected from September, 2013-April, 2015 Participants A sample size of 30 was deemed sufficient to determine the intervention’s feasibility with respect to adherence to the exercise treatment protocol.20-22 The study was not powered to detect significant differences in smoking abstinence rates, but we sought to obtain estimates of the intervention effect towards planning a definitive trial A doubling of the abstinence rate for the intervention vs control condition at end-of-treatment was considered to be of clinical significance and warrant proceeding to an efficacy trial 23 Participants were recruited by provider referrals and flyers posted in the clinic, and radio and newspaper advertisements Initial screening was completed by telephone Eligible women were asked to complete an in-person screening assessment After obtaining written informed consent, the study coordinator administered the MINI International Neuropsychiatric Interview,24 to rule out bipolar and thought disorders Participants then completed a urine pregnancy test and provided height and weight If eligible, individuals completed a baseline self-report questionnaire and exercise testing.25 Potential participants received the Modular Signal Recorder (MSR) accelerometer to wear for at least four days and return in a pre-paid envelope If the MSR was returned, the participant was enrolled Eligibility criteria were: female, aged 18-55 years, smoked > 10 cigarettes a day for at least the past year, willing to make a quit attempt, currently depressed defined by a clinical cutoff score of >16 on the 10-item Center for Epidemiological Studies Depression Scale corresponding to moderate-severe depression (CES-D),26 not currently meeting the ACSM guidelines for exercise,27 willing and able to participate in all aspects of the study, provide written informed consent, and if using antidepressant medication, no changes in dose or type of medication during the past three months Exclusionary criteria were: positive pregnancy test (urine dipstick test), currently breastfeeding, or planning to become pregnant during the nicotine patch study phase, physical limitations to participate in vigorous intensity exercise or submaximal exercise testing (PAR-Q),28 current use (past three months) of smokeless tobacco products, or stop smoking medications or behavioral treatments, any medical condition precluding nicotine patch use, current or lifetime DSM-IV diagnosis of bipolar disorder, schizophrenia/other major thought disorder, and another person from the same household had enrolled There was no upper cutoff for body mass index (BMI) if no other cardiovascular risk factors were present if BMI was >30 One hundred five individuals were screened by telephone, of which 30 (29%) were enrolled (Figure 1) Sixty-two of those not enrolled did not meet the study eligibility criteria and the primary reason was a CES-D score 0.05 for all variables when comparing health education and exercise interventions on the baseline assessment using a two sample t-test b Analysis of Covariance (ANCOVA) assessing change in measures For these analyses, the week 12 assessment was the dependent variable and treatment group and the baseline assessment were the independent variables c Volume of oxygen consumed in mLs of oxygen per kilogram of body weight per minute d The prediction equation accounts for participant age e Data generated from Modular Signal Recorder (MSR) accelerometer 31 ... an exercise counseling intervention for depressed women smokers Nicotine Tob Res 2009;11(8):985-995 doi:10.1093/ntr/ntp101 11 Bernard P, Ninot G, Cyprien F, et al Exercise and counseling for. .. contact control group.10,11 A supervised exercise program has the potential to benefit depressed smokers by providing reinforcement, guidance, and support for exercise; thus improving adherence.16... indicated that only two women in the exercise condition attended that facility after Week 12; of these, one exercised twice, another exercised 47 times Thus, a key challenge for the field is to discover