Clinical trial NCT03163056: Smoking Cessation Treatment for Depressed Smokers
Official title: Behavioral Activation and Voucher-based Contingency Management for Smokers With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: Smoking cessation
Depression
Clinical trial
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: smoking abstinence
timeFrame: end of treatment (8-week)
measure: smoking abstinence
timeFrame: 1 month follow-up
measure: smoking abstinence
timeFrame: 2 months follow-up
measure: smoking abstinence
timeFrame: 3 months follow-up
measure: smoking abstinence
timeFrame: 6 months follow-up
Secondary outcomes:
measure: depression
timeFrame: intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up
measure: behavioral activation
timeFrame: intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up
measure: environmental reward
timeFrame: intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up
measure: cigarette craving
timeFrame: intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up
measure: anxiety
timeFrame: intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up
measure: impulsivity
timeFrame: intake (baseline), end of treatment (8-week),1,2,3 and 6 months follow-up
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Clinical Unit of Addictive Behaviors
state: Asturias
Study officials:
affiliation: University of Oviedo
name: Roberto Secades-Villa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.