Smoking Cessation Treatment for Depressed Smokers

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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).

BEHAVIORAL

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).

Sponsors & Collaborators

• University of Oviedo

  lead OTHER

Principal Investigators

• Roberto Secades-Villa, PhD · University of Oviedo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-26

Primary Completion

2019-07-31

Completion

2019-07-31

Countries

• Spain

Study Locations