Study Results
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Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2015-01-26
2019-07-31
Brief Summary
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The main goals are:
1\. To assess abstinence rates in each of the above-mentioned treatment conditions conditions at short and long-term follow-ups: post-treatment, once during the first three months, and at at six after post-treatment.
1\. To assess the effectiveness (relapse rate) of each treatment condition at short and long-term follow-ups: post-treatment, once during the first three months,and at six after post-treatment.
3\. To analyze efficiency (cost-efficacy) and feasibility of the treatments to a community setting.
4\. To analyze the moderating effect of individual variables over treatment outcomes. In particular, moderating variables will be: sociodemographic characteristics, severity of nicotine dependence, severity of depressive symptomatology and impulsivity.
The study hypothesis are:
1-Adding a voucher-based CM component to CBT+BA will enhance abstinence rates and decrease both short and long-term relapse rates.
2\. Providing smoking cessation treatments that include a mood management component (BA or BA+CM) will have a positive impact in ameliorating depression.
3\. Certain individual variables (e.g., gender, nicotine dependence and depression severity and impulsivity) will have a moderating effect on treatment outcomes.
4\. Both CBT+BA and CBT+BA+CM will prove cost-effectiveness and thus may be generalized to a clinical and community context.
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Detailed Description
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The primary aim of this clinical trial is to yield data on the effectiveness of BA and CM for smoking cessation in smokers with depression. To address this issue, both BA and CM interventions will be compared with a standard smoking cessation treatment, namely Cognitive-behavioral treatment (CBT) for smoking cessation. Participants will be assigned to one of the following three treatment conditions: 1) Cognitive-behavioral treatment for smoking cessation (CBT); 2) CBT plus Behavioral Activation (BA); 3) CBT+BA+Contingency Management (CM).
Regarding the factors contributing to improve the quality of the present clinical trial, sample size was estimated using the software G\*Power 3.1. An estimated sample size of 150 participants would detect a medium effect size (Cohen's d = 0.3, with power (1-β) set at 0.97 and α = 05).
Given that data will be collected up to six months after post-treatment, moderate rates of lost to follow-up can be expected. However, the sample size estimate in this study will be sufficient to ensure a representative distribution of the population to whom results will be generalized.
The primary analyses derived from this clinical trial will be conducted using Statistical Package for the Social Science (SPSS) version 22 for Windows. A set of descriptive and frequency analyses will be carried out with regard to the participants' characteristics. Comparisons between the treatment groups for baseline characteristics will be conducted using t-tests for independent groups. A set of chi-square tests for categorical variables, and independent samples t-tests (two-tailed) for continuous variables (after Levene's correction for inequality of variance) will be performed to examine the main effect of each treatment condition on abstinence and relapse rates.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cognitive-behavioral treatment (CBT)
The CBT treatment condition is implemented in group-based sessions carried out during 8 weeks. Components included: information about tobacco, behavioral contract whereby patients committed to attend sessions, self-monitoring and graphical representation of cigarette smoking, nicotine fading (a weekly reduction of 30% of nicotine intake from the first to the four week, and abstinence from the fifth week onwards), physiological feedback (CO in expired air and cotinine analyses) on cigarette intake, stimulus control, strategies for managing nicotine withdrawal symptoms, training in alternative behaviors, and relapse prevention strategies (e.g., problem solving techniques).
Cognitive-behavioral treatment (CBT)
The CBT was implemented in group-based sessions of four patients. Sessions were carried out once a week over a 8-week period, with quite date occurring at fifth session. The main component was nicotine fading. From the first to the fourth week, patients were asked to gradually reduce their nicotine intake based on a weekly reduction of 30%. A maximum number of cigarettes per day and also specific cigarette brands with lower nicotine levels were recommended. Other components of the CBT program included information about tobacco, a behavioral contract, self monitoring and graphical representation of cigarette smoking, stimulus control, strategies for controlling nicotine withdrawal symptoms, physiological feedback, training in alternative behaviors, and relapse prevention strategies.
CBT+Behavioral Activation (BA)
This intervention includes both CBT and BA strategies for smoking cessation and depression management. Participants allocated to this condition received 8 therapy sessions. The BA module included: treatment rationale, information on the relationship between smoking and depression, identification of life areas, values and activities, generation of meaningful and reinforcing activities, social support (i.e., behavioral contracts).
Cognitive-behavioral treatment (CBT)
The CBT was implemented in group-based sessions of four patients. Sessions were carried out once a week over a 8-week period, with quite date occurring at fifth session. The main component was nicotine fading. From the first to the fourth week, patients were asked to gradually reduce their nicotine intake based on a weekly reduction of 30%. A maximum number of cigarettes per day and also specific cigarette brands with lower nicotine levels were recommended. Other components of the CBT program included information about tobacco, a behavioral contract, self monitoring and graphical representation of cigarette smoking, stimulus control, strategies for controlling nicotine withdrawal symptoms, physiological feedback, training in alternative behaviors, and relapse prevention strategies.
CBT+Behavioral Activation (BA)
This intervention was provided as in the above CBT condition, that is, eight group-based sessions of four patients. Nevertheless, this treatment included a BA component for addressing both smoking cessation and depression management. The BA module included: treatment rationale, information on the relationship between smoking and depression, identification of life areas, values and activities, generation of meaningful and reinforcing activities, social support (i.e., behavioral contracts).
CBT+BA+ Contingency Management (CM)
This intervention is provided in the same manner as the above treatment protocols but with the addition of a CM procedure reinforcing abstinence since fifth session and onwards. The number of sessions was the same as in the aforementioned treatment conditions and CO and cotinine samples were also collected. Participants providing negative specimens of both CO (≤4 ppm) and cotinine (≤80 ng/ml) earned points exchangeable for rewards (e.g., cinema tickets) on a schedule of escalating magnitude of reinforcement (from 10€ voucher value with maximum possible earnings of 175€ in vouchers).
Cognitive-behavioral treatment (CBT)
The CBT was implemented in group-based sessions of four patients. Sessions were carried out once a week over a 8-week period, with quite date occurring at fifth session. The main component was nicotine fading. From the first to the fourth week, patients were asked to gradually reduce their nicotine intake based on a weekly reduction of 30%. A maximum number of cigarettes per day and also specific cigarette brands with lower nicotine levels were recommended. Other components of the CBT program included information about tobacco, a behavioral contract, self monitoring and graphical representation of cigarette smoking, stimulus control, strategies for controlling nicotine withdrawal symptoms, physiological feedback, training in alternative behaviors, and relapse prevention strategies.
CBT+Behavioral Activation (BA)
This intervention was provided as in the above CBT condition, that is, eight group-based sessions of four patients. Nevertheless, this treatment included a BA component for addressing both smoking cessation and depression management. The BA module included: treatment rationale, information on the relationship between smoking and depression, identification of life areas, values and activities, generation of meaningful and reinforcing activities, social support (i.e., behavioral contracts).
CBT+BA+ Contingency Management (CM)
This intervention was provided in the same manner as the above mentioned treatment protocols but with the addition of a contingency management procedure reinforcing abstinence since fifth session and onwards. The number of sessions was the same as in the aforementioned treatment conditions and CO and cotinine samples were also collected. Participants providing negative specimens of both CO (≤4 ppm) and cotinine (≤80 ng/ml) earned points exchangeable for rewards (e.g., cinema tickets) on a schedule of escalating magnitude of reinforcement (from 10€ voucher value with maximum possible earnings of 175€ in vouchers).
Interventions
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Cognitive-behavioral treatment (CBT)
The CBT was implemented in group-based sessions of four patients. Sessions were carried out once a week over a 8-week period, with quite date occurring at fifth session. The main component was nicotine fading. From the first to the fourth week, patients were asked to gradually reduce their nicotine intake based on a weekly reduction of 30%. A maximum number of cigarettes per day and also specific cigarette brands with lower nicotine levels were recommended. Other components of the CBT program included information about tobacco, a behavioral contract, self monitoring and graphical representation of cigarette smoking, stimulus control, strategies for controlling nicotine withdrawal symptoms, physiological feedback, training in alternative behaviors, and relapse prevention strategies.
CBT+Behavioral Activation (BA)
This intervention was provided as in the above CBT condition, that is, eight group-based sessions of four patients. Nevertheless, this treatment included a BA component for addressing both smoking cessation and depression management. The BA module included: treatment rationale, information on the relationship between smoking and depression, identification of life areas, values and activities, generation of meaningful and reinforcing activities, social support (i.e., behavioral contracts).
CBT+BA+ Contingency Management (CM)
This intervention was provided in the same manner as the above mentioned treatment protocols but with the addition of a contingency management procedure reinforcing abstinence since fifth session and onwards. The number of sessions was the same as in the aforementioned treatment conditions and CO and cotinine samples were also collected. Participants providing negative specimens of both CO (≤4 ppm) and cotinine (≤80 ng/ml) earned points exchangeable for rewards (e.g., cinema tickets) on a schedule of escalating magnitude of reinforcement (from 10€ voucher value with maximum possible earnings of 175€ in vouchers).
Eligibility Criteria
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Inclusion Criteria
* having smoked 10 or more cigarettes/day within the last year
* meeting criteria for current unipolar major depression disorder according to the Diagnostic and Statistical Manual of Mental Disorders-4th ed., text rev (DSM-IV-TR) (American Psychiatric Association 2000).
, and/or scoring ≥ 14 on the Beck Depression Inventory (Beck, Steer, \& Brown, 1996)
* meeting the diagnostic criteria for nicotine dependence according to the Diagnostic and Statistical Manual of Mental Disorders-4th ed., text rev (DSM-IV-TR) (American Psychiatric Association 2000).
Exclusion Criteria
* suffering from severe mental disorders others than depression such as cognitive impairment, a psychotic disorder or bipolar disorder.
* being currently receiving other psychological treatment for smoking cessation or depression.
* meeting criteria for abuse and/or dependence on a substance other than nicotine.
18 Years
ALL
No
Sponsors
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University of Oviedo
OTHER
Responsible Party
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Roberto Secades
Professor/PhD
Principal Investigators
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Roberto Secades-Villa, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oviedo
Locations
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Clinical Unit of Addictive Behaviors
Oviedo, Principality of Asturias, Spain
Countries
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References
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Secades-Villa R, Garcia-Rodriguez O, Lopez-Nunez C, Alonso-Perez F, Fernandez-Hermida JR. Contingency management for smoking cessation among treatment-seeking patients in a community setting. Drug Alcohol Depend. 2014 Jul 1;140:63-8. doi: 10.1016/j.drugalcdep.2014.03.030. Epub 2014 Apr 8.
MacPherson L, Tull MT, Matusiewicz AK, Rodman S, Strong DR, Kahler CW, Hopko DR, Zvolensky MJ, Brown RA, Lejuez CW. Randomized controlled trial of behavioral activation smoking cessation treatment for smokers with elevated depressive symptoms. J Consult Clin Psychol. 2010 Feb;78(1):55-61. doi: 10.1037/a0017939.
van der Meer RM, Willemsen MC, Smit F, Cuijpers P. Smoking cessation interventions for smokers with current or past depression. Cochrane Database Syst Rev. 2013 Aug 21;(8):CD006102. doi: 10.1002/14651858.CD006102.pub2.
Secades-Villa R, Vallejo-Seco G, Garcia-Rodriguez O, Lopez-Nunez C, Weidberg S, Gonzalez-Roz A. Contingency management for cigarette smokers with depressive symptoms. Exp Clin Psychopharmacol. 2015 Oct;23(5):351-60. doi: 10.1037/pha0000044. Epub 2015 Aug 17.
Notley C, Gentry S, Livingstone-Banks J, Bauld L, Perera R, Conde M, Hartmann-Boyce J. Incentives for smoking cessation. Cochrane Database Syst Rev. 2025 Jan 13;1(1):CD004307. doi: 10.1002/14651858.CD004307.pub7.
Gonzalez-Roz A, Weidberg S, Garcia-Perez A, Martinez-Loredo V, Secades-Villa R. One-Year Efficacy and Incremental Cost-effectiveness of Contingency Management for Cigarette Smokers With Depression. Nicotine Tob Res. 2021 Jan 22;23(2):320-326. doi: 10.1093/ntr/ntaa146.
Weidberg S, Secades-Villa R, Garcia-Perez A, Gonzalez-Roz A, Fernandez-Hermida JR. The synergistic effect of cigarette demand and delay discounting on nicotine dependence among treatment-seeking smokers. Exp Clin Psychopharmacol. 2019 Apr;27(2):146-152. doi: 10.1037/pha0000248. Epub 2018 Dec 20.
Other Identifiers
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PSI2015-64371-P
Identifier Type: -
Identifier Source: org_study_id
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