Paquito Bernard1,2, Gregory Ninot1, Fabienne Cyprien3, Philippe Courtet4,5, Sebastien Guillaume4,5, Vera Georgescu6, Marie-Christine Picot6, Adrian Taylor7, Xavier Quantin1,2. 1. a Laboratory Epsylon EA 4556, Dynamics of Human Abilities and Health Behaviors, University of Montpellier , Montpellier , France. 2. b Department of Respiratory Medicine , University Hospital of Montpellier , Montpellier , France. 3. c University Department of Adult Psychiatry, Hôpital Carémeau, University Hospital of Nîmes , Nîmes , France. 4. d INSERM Institut National Pour la Santé et la Recherche Médicale , Montpellier , France. 5. e University Department of Adult Psychiatry, Hôpital de la Colombière, University Hospital of Montpellier , Montpellier , France. 6. f Department of Medical Information , University Hospital of Montpellier, Montpellier-1 University , Montpellier , France. 7. g Plymouth University Peninsula School of Medicine and Dentistry , Plymouth , UK.
Abstract
OBJECTIVE: Despite various strategies to help smokers with depressive disorders to quit, the smoking relapse rate remains high. The purpose of this pilot study was to estimate the effects of adding an exercise and counseling intervention to standard smoking cessation treatment for smokers with depressive disorders. We hypothesized that the exercise and counseling intervention would lead to improved abstinence, reduced depressive symptoms, and increased physical activity. METHODS:Seventy smokers with current depressive disorders were randomly assigned to standard smoking cessation treatment plus exercise and counseling (n = 35) or standard treatment plus a time-to-contact control intervention on health education (n = 35). Both programs involved 10 sessions over 8 weeks. The primary outcome was continuous abstinence since the quit date and was measured at week 8 (end of the intervention) and again at 12-, 24-, and 52-week follow-ups. RESULTS:Nearly 60% of participants were female (n = 41), 38 (52.3%) were single, 37 (52.9%) had education beyond high school, and 32 (45.7%) met criteria for major depressive disorder or dysthymia. Participants in the two treatment conditions differed at baseline only in marital status (χ(2) = 4.28, df = 1, p =.04); and smoking abstinence self-efficacy, t(66) = -2.04, p =.04). The dropout rate did not differ significantly between groups and participants attended 82% and 75% of the intervention and control sessions, respectively. Intention-to-treat analysis showed that, at 12 weeks after the beginning of the intervention, continuous abstinence did not vary significantly between the intervention and control groups: 48.5% versus 28.5%, respectively, ORadj = 0.40, 95% CI [0.12-1.29], p =.12. There were no group differences in depressive symptoms, but the intervention group did outperform the control group on the 6-minute walking test (Mint = 624.84, SD = 8.17, vs. Mcon = 594.13, SD = 8.96, p =.015) and perceived physical control (Mint = 2.84, SD = 0.16, vs. Mcon = 2.27, SD = 0.18, p =.028). The sample was not large enough to ensure adequate statistical power. CONCLUSIONS: This finding, while preliminary, suggests that an exercise and counseling intervention may yield better results than health education in improving smoking abstinence. This study is registered at www.clinincaltrials.gov under # NCT01401569.
RCT Entities:
OBJECTIVE: Despite various strategies to help smokers with depressive disorders to quit, the smoking relapse rate remains high. The purpose of this pilot study was to estimate the effects of adding an exercise and counseling intervention to standard smoking cessation treatment for smokers with depressive disorders. We hypothesized that the exercise and counseling intervention would lead to improved abstinence, reduced depressive symptoms, and increased physical activity. METHODS: Seventy smokers with current depressive disorders were randomly assigned to standard smoking cessation treatment plus exercise and counseling (n = 35) or standard treatment plus a time-to-contact control intervention on health education (n = 35). Both programs involved 10 sessions over 8 weeks. The primary outcome was continuous abstinence since the quit date and was measured at week 8 (end of the intervention) and again at 12-, 24-, and 52-week follow-ups. RESULTS: Nearly 60% of participants were female (n = 41), 38 (52.3%) were single, 37 (52.9%) had education beyond high school, and 32 (45.7%) met criteria for major depressive disorder or dysthymia. Participants in the two treatment conditions differed at baseline only in marital status (χ(2) = 4.28, df = 1, p =.04); and smoking abstinence self-efficacy, t(66) = -2.04, p =.04). The dropout rate did not differ significantly between groups and participants attended 82% and 75% of the intervention and control sessions, respectively. Intention-to-treat analysis showed that, at 12 weeks after the beginning of the intervention, continuous abstinence did not vary significantly between the intervention and control groups: 48.5% versus 28.5%, respectively, ORadj = 0.40, 95% CI [0.12-1.29], p =.12. There were no group differences in depressive symptoms, but the intervention group did outperform the control group on the 6-minute walking test (Mint = 624.84, SD = 8.17, vs. Mcon = 594.13, SD = 8.96, p =.015) and perceived physical control (Mint = 2.84, SD = 0.16, vs. Mcon = 2.27, SD = 0.18, p =.028). The sample was not large enough to ensure adequate statistical power. CONCLUSIONS: This finding, while preliminary, suggests that an exercise and counseling intervention may yield better results than health education in improving smoking abstinence. This study is registered at www.clinincaltrials.gov under # NCT01401569.
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