Smoking Cessation Treatment for Depressed Smokers

NCT03163056 | Completed

• 1 other identifier: PSI2015-64371-P
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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. 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: 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.

Conditions

Tobacco Use Disorder

Keywords

Smoking cessation; Depression; Clinical trial

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  6 months follow-up

Secondary Outcomes (6)

• depression

  intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up

• behavioral activation

  intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up

• environmental reward

  intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up

• cigarette craving

  intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up

• anxiety

  intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up

Study Arms (3)

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).

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).

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).

Behavioral: Cognitive-behavioral treatment (CBT); Behavioral: CBT+Behavioral Activation (BA); Behavioral: CBT+BA+ Contingency Management (CM)

Interventions

Cognitive-behavioral treatment (CBT) BEHAVIORAL

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+BA+ Contingency Management (CM); CBT+Behavioral Activation (BA); Cognitive-behavioral treatment (CBT)

CBT+Behavioral Activation (BA) BEHAVIORAL

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); CBT+Behavioral Activation (BA)

CBT+BA+ Contingency Management (CM) BEHAVIORAL

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).

CBT+BA+ Contingency Management (CM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oviedo: lead

Study Sites (1)

Clinical Unit of Addictive Behaviors

Oviedo, Principality of Asturias, 33003, Spain

Location

Related Publications (7)

• 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.

  PMID: 24768410 BACKGROUND

• 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.

  PMID: 20099950 BACKGROUND

• 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.

  PMID: 23963776 BACKGROUND

• 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.

  PMID: 26280589 BACKGROUND

• 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.

  PMID: 39799985 DERIVED

• 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.

  PMID: 32772097 DERIVED

• 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.

  PMID: 30570273 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation; Depression

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior; Behavioral Symptoms

Study Officials

• Roberto Secades-Villa, PhD

  University of Oviedo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/PhD

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 22, 2017
• Study Start: January 26, 2015
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)