Tobacco Use DisorderNCT03163056
Smoking Cessation Treatment for Depressed Smokers
A study testing Cognitive-behavioral treatment (CBT), CBT+Behavioral Activation (BA) and CBT+BA+ Contingency Management (CM) in people with Tobacco Use Disorder, run by University of Oviedo at 1 site in Spain.
Trial summary
The present research project aims to develop an innovative and empirically validated intervention protocol for smoking cessation among patients with depressive symptoms. For this purpose, two smoking cessation treatments tailored for managing depression will be compared with a standard smoking cessation treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Cognitive-behavioral treatment (CBT), CBT+Behavioral Activation (BA) and CBT+BA+ Contingency Management (CM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 26 Jan 2015to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being age 18 or over
- 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).
Who cannot join
- not being able to attend the entire treatment,
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clinical Unit of Addictive Behaviors
Oviedo, Principality of Asturias, 33003
About this study
Official title: Behavioral Activation and Voucher-based Contingency Management for Smokers With Depression
The present research project aims to develop an innovative and empirically validated intervention protocol for smoking cessation among patients with depressive symptoms. For this purpose, two smoking cessation treatments tailored for managing depression will be compared with a standard smoking cessation treatment. 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).
The main goals are:
Read more
- 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.
- 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.
- To analyze efficiency (cost-efficacy) and feasibility of the treatments to a community setting.
- 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.
- Providing smoking cessation treatments that include a mood management component (BA or BA+CM) will have a positive impact in ameliorating depression.
- Certain individual variables (e.g., gender, nicotine dependence and depression severity and impulsivity) will have a moderating effect on treatment outcomes.
- Both CBT+BA and CBT+BA+CM will prove cost-effectiveness and thus may be generalized to a clinical and community context.
Read the detailed description
Cigarette smoking continues to have a startling adverse impact on public health, leading to more than 5 million premature deaths annually worldwide. Smoking rates are disproportionately high among the population suffering from depression. In this regard, smokers with comorbid depression are more likely to smoke heavily and meet criteria for high nicotine dependence. It is also more probable that they experience negative mood changes after withdrawal and show shorter time to relapse and lower rates of abstinence when attempting to quit compared to non-depressed smokers. In recent years there has been a great interest in developing effective strategies to promote abstinence in smokers with depression. In particular, a proliferation on Behavioral Activation (BA) treatments for smokers with depression has been recently produced. There is promising evidence for the positive effect of BA treatments upon both quitting smoking and depression. On the other hand, Contingency Management (CM) has shown promising results in promoting both retention and nicotine abstinence among comorbid and non-comorbid smokers. Nevertheless, there is a lack of research exploring the effectiveness of CM on smokers with depression.
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
- Tobacco Use Disorder
- Being tested
- Cognitive-behavioral treatment (CBT), CBT+Behavioral Activation (BA), CBT+BA+ Contingency Management (CM)
- Keywords
- Smoking cessation, Depression, Clinical trial
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral treatment (CBT)Behavioural
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)Behavioural
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)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-behavioral treatment (CBT) | Other | 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). Receives: Behavioral: Cognitive-behavioral treatment (CBT) |
| CBT+Behavioral Activation (BA) | Active comparator | 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). Receives: Behavioral: Cognitive-behavioral treatment (CBT); Behavioral: CBT+Behavioral Activation (BA) |
| CBT+BA+ Contingency Management (CM) | Active comparator | 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). Receives: Behavioral: Cognitive-behavioral treatment (CBT); Behavioral: CBT+Behavioral Activation (BA); Behavioral: CBT+BA+ Contingency Management (CM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoking abstinence
Abstinence is considered when participants met the following criterion: 24-hours point prevalence abstinence. Abstinence is confirmed by asking participants to provide a sample of carbon monoxide (CO) and cotinine urine.
Measured: end of treatment (8-week)
smoking abstinence
Abstinence is considered when participants met the following criterion: 7-day point prevalence abstinence. Abstinence is confirmed by asking participants to provide a sample of carbon monoxide (CO) and cotinine urine.
Measured: 1 month follow-up
smoking abstinence
Abstinence is considered when participants met the following criterion: 7-day point prevalence abstinence. Abstinence is confirmed by asking participants to provide a sample of carbon monoxide (CO) and cotinine urine.
Measured: 2 months follow-up
smoking abstinence
Abstinence is considered when participants met the following criterion: 7-day point prevalence abstinence. Abstinence is confirmed by asking participants to provide a sample of carbon monoxide (CO) and cotinine urine.
Measured: 3 months follow-up
smoking abstinence
Abstinence is considered when participants met the following criterion: 7-day point prevalence abstinence. Abstinence is confirmed by asking participants to provide a sample of carbon monoxide (CO) and cotinine urine.
Measured: 6 months follow-up
Secondary outcomes (6)
depression
Changes in depression are assessed using the Beck's Depression Inventory- Second Edition (BDI-II). Scores are examined as a continuous scale. None/minimal depression is defined as scoring below the clinical screening BDI cutoff of mild depression (<14). Depression diagnosis is assessed in those individuals scoring 14 or more on the BDI-II by means of the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-Clinical Version (SCID-I/CV).
Measured: intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up
behavioral activation
In order to assess behavioral activation, we use the Behavioral Activation for Depression Scale-Short Form (BADS-SF) (Kanter, Mulick, Busch, \& Martell, 2012). This instrument can be used to track changes weekly in the behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation. It examines changes in the following areas: activation, avoidance/rumination, work/school impairment, and social impairment. The BADS-SF consists of 9 questions, each rated on a seven point scale ranging from 0 (not at all) to 6 (completely).
Measured: intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up
environmental reward
The Environmental Reward Observation Scale (EROS)(Barraca \& Pérez-Álvarez, 2010) is used to assess this outcome.The EROS is a brief, reliable and valid measure of environmental reward that improves the psychological assessment of negative mood states such as clinical depression. It consists of 10 items rated on a four point scale ranging from 1 (completely disagree) to 4 (completely agree).
Measured: intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up
cigarette craving
The Questionnaire of smoking urges (QSU-Brief) (Cox, Tiffany \& Christen, 2001) is used to assess cigarette craving. This 10-item, self-report instrument provides an adequate assessment of multiple aspects of cigarette craving. All items are rated on a seven point scale raging from 1 (completely disagree) to 7 (completely agree). Factor analyses revealed that this instrument has a two-factor solution. The first factor reflects a strong desire and intention to smoke, with smoking perceived as rewarding for active smokers. The second factor represents an anticipation of relief from negative affect with an urgent desire to smoke.
Measured: intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up
anxiety
To assess anxiety levels, we use the State-Trait Anxiety Inventory (STAI) (Spielberger, Gorsuch, Lushene, Vagg \& Jacobs, 1983). This is a widely used self-report instrument that assesses the presence and severity of current symptoms of anxiety and a generalized propensity to be anxious. There are two subscales within this measure. The first is the the State Anxiety Scale (S-Anxiety) that evaluates the current state of anxiety. The second is the Trait Anxiety Scale (T-Anxiety) that evaluates relatively stable aspects of "anxiety proneness," including general states of calmness, confidence, and security. It has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always").
Measured: intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up
impulsivity
Impulsivity levels are assessed by means of the delay discounting task. Participants complete a computerized version of this task. They are presented with several choices, ranging from notionally being given €1,000 after a fixed delay, versus various amounts of money given immediately using an adjusting-amount procedure (Holt, Green, \& Myerson, 2012). The delay values used are one day, one week, one month, six months, one year, five years, and 25 years. Delay discounting is calculated using logk and the area under the curve (AUC).
Measured: intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start26 Jan 2015
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to each of the three treatment conditions in accordance with a computer-generated randomization list. The three treatment conditions will be actively running in parallel.
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Secades, University of Oviedo
- Investigators
- Roberto Secades-Villa, PhD, Principal investigator, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163056
- Sponsor's protocol ID
- PSI2015-64371-P
- Status last verified
- Sep 2019
- First submitted
- 15 May 2017
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24768410MacPherson 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.
PubMed 20099950van 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;2013(8):CD006102. doi: 10.1002/14651858.CD006102.pub2.
PubMed 23963776Secades-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.
PubMed 26280589Notley 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.
PubMed 39799985Gonzalez-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.
PubMed 32772097Weidberg 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.
PubMed 30570273
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation and Voucher-based Contingency Management for Smokers With Depression
- ClinicalTrials.gov ID
- NCT03163056
- Acronym / sponsor ID
- PSI2015-64371-P
- Conditions
- Tobacco Use Disorder
- Keywords
- Smoking cessation, Depression, Clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 26 Jan 2015 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present research project aims to develop an innovative and empirically validated intervention protocol for smoking cessation among patients with depressive symptoms. For this purpose, two smoking cessation treatments tailored for managing depression will be compared with a standard smoking cessation treatment. 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).
The main goals are:
- 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.
- 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.
- To analyze efficiency (cost-efficacy) and feasibility of the treatments to a community setting.
- 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.
- Providing smoking cessation treatments that include a mood management component (BA or BA+CM) will have a positive impact in ameliorating depression.
- Certain individual variables (e.g., gender, nicotine dependence and depression severity and impulsivity) will have a moderating effect on treatment outcomes.
- Both CBT+BA and CBT+BA+CM will prove cost-effectiveness and thus may be generalized to a clinical and community context.
Detailed description
Cigarette smoking continues to have a startling adverse impact on public health, leading to more than 5 million premature deaths annually worldwide. Smoking rates are disproportionately high among the population suffering from depression. In this regard, smokers with comorbid depression are more likely to smoke heavily and meet criteria for high nicotine dependence. It is also more probable that they experience negative mood changes after withdrawal and show shorter time to relapse and lower rates of abstinence when attempting to quit compared to non-depressed smokers. In recent years there has been a great interest in developing effective strategies to promote abstinence in smokers with depression. In particular, a proliferation on Behavioral Activation (BA) treatments for smokers with depression has been recently produced. There is promising evidence for the positive effect of BA treatments upon both quitting smoking and depression. On the other hand, Contingency Management (CM) has shown promising results in promoting both retention and nicotine abstinence among comorbid and non-comorbid smokers. Nevertheless, there is a lack of research exploring the effectiveness of CM on smokers with depression.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to each of the three treatment conditions in accordance with a computer-generated randomization list. The three treatment conditions will be actively running in parallel.
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioral treatment (CBT) | Other | Behavioral: 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). |
| CBT+Behavioral Activation (BA) | Active comparator | Behavioral: Cognitive-behavioral treatment (CBT), Behavioral: 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). |
| CBT+BA+ Contingency Management (CM) | Active comparator | Behavioral: Cognitive-behavioral treatment (CBT), Behavioral: CBT+Behavioral Activation (BA), Behavioral: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- being age 18 or over
- 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).
Key exclusion criteria (4 listed)
- not being able to attend the entire treatment,
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CBT+BA+ Contingency Management (CM), CBT+Behavioral Activation (BA), Cognitive-behavioral treatment (CBT) |
| 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). | Behavioural | CBT+BA+ Contingency Management (CM), CBT+Behavioral Activation (BA) |
| 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). | Behavioural | CBT+BA+ Contingency Management (CM) |
Primary outcome
smoking abstinence
Time frame: end of treatment (8-week)
Abstinence is considered when participants met the following criterion: 24-hours point prevalence abstinence. Abstinence is confirmed by asking participants to provide a sample of carbon monoxide (CO) and cotinine urine.
smoking abstinence
Time frame: 1 month follow-up
Abstinence is considered when participants met the following criterion: 7-day point prevalence abstinence. Abstinence is confirmed by asking participants to provide a sample of carbon monoxide (CO) and cotinine urine.
smoking abstinence
Time frame: 2 months follow-up
Abstinence is considered when participants met the following criterion: 7-day point prevalence abstinence. Abstinence is confirmed by asking participants to provide a sample of carbon monoxide (CO) and cotinine urine.
smoking abstinence
Time frame: 3 months follow-up
Abstinence is considered when participants met the following criterion: 7-day point prevalence abstinence. Abstinence is confirmed by asking participants to provide a sample of carbon monoxide (CO) and cotinine urine.
smoking abstinence
Time frame: 6 months follow-up
Abstinence is considered when participants met the following criterion: 7-day point prevalence abstinence. Abstinence is confirmed by asking participants to provide a sample of carbon monoxide (CO) and cotinine urine.
6 secondary outcomes
depression
Time frame: intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up
behavioral activation
Time frame: intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up
environmental reward
Time frame: intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up
cigarette craving
Time frame: intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up
anxiety
Time frame: intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up
impulsivity
Time frame: intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Background: PubMed 24768410Secades-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.
- Background: PubMed 20099950MacPherson 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.
- Background: PubMed 23963776van 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;2013(8):CD006102. doi: 10.1002/14651858.CD006102.pub2.
- Background: PubMed 26280589Secades-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.
- Derived from this study: PubMed 39799985Notley 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.
- Derived from this study: PubMed 32772097Gonzalez-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.
- Derived from this study: PubMed 30570273Weidberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Secades-Villa, PhD principal investigator
University of Oviedo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral treatment (CBT), CBT+Behavioral Activation (BA) and CBT+BA+ Contingency Management (CM) in people with Tobacco Use Disorder, run by University of Oviedo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
smoking abstinence (time frame: end of treatment (8-week)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03163056, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.