Behavioural Activation Treatment for Smoking Cessation and Depressive Symptomatology: a Randomized Controlled Trial

Study Overview
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Brief Summary
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The number of people who smoke, have concurrent depression and that seek treatment for smoking cessation has increased in recent years. This implies the need to design intensive and specific interventions that target this issue. In depression treatment, behavioural activation is one of the psychological interventions whose characteristics of brevity, flexibility and efficiency make it an ideal candidate to be included as part of smoking cessation treatment, especially when smokers have depressive symptoms. The aims of the present trial are: 1) to assess the efficacy (abstinence rates) of a psychological smoking cessation treatment with elements from behavioural activation for managing depressed mood (a randomized control trial with three groups: standard cognitive-behavioural smoking cessation treatment, standard cognitive-behavioural smoking cessation treatment plus behavioural activation, and a control group of delayed treatment) at the end of treatment, and at 3-, 6-, and 12-months follow-ups; and 2) to assess whether the applied cognitive-behavioural smoking cessation treatment plus behavioural activation improves depressed mood at the end of treatment and 3-, 6, 12-months follow-ups.

Detailed Description
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In recent years there has been a great interest in analyzing the relationship between smoking and depression due to the high smoking rates in this population. Smokers with depression are more likely to smoke heavily, show greater tobacco dependence, suffer more severe withdrawal, experience lower quit rates and have more relapse than smokers without depression. Some studies propose the inclusion of behavioural activation techniques to standard cognitive-behavioural therapy for quitting smoking, arguing that the loss of the ability to experience pleasure in response to daily activities after quitting smoking is a significant barrier to achieving and maintaining abstinence. With this type of intervention, the exposure to positive reinforcers alternative to cigarettes increases and the resulting distress of withdrawal syndrome it is also reduced. Therefore, behavioural activation may improve smoking abstinence rates and depressive symptomatology. This project aims to assess the effectiveness of a psychological intervention for smoking cessation with components of behavioural activation for managing depressed mood. We will use a single blind controlled randomized design. Two hundred and fifty daily (≥ 10 cigarettes/day) smokers will be randomized to one of three conditions: 1) standard cognitive-behavioural smoking cessation treatment (n=100); 2) standard cognitive-behavioural smoking cessation treatment plus behavioural activation (n=100); or 3) a control group of three months delayed treatment (n=50). Both active treatments will be administered in eight weekly 60 minute sessions. The primary outcomes will be carbon monoxide (CO) verified at 24-hours point prevalence abstinence at the end of the treatment, a 7-day point prevalence abstinence at 3 months follow-up, a 30-days point prevalence abstinence at 6-, and 12-months follow-ups; and depressive symptomatology through BDI-II and Hamilton Depression Rating Scale scores at the end of treatment, and at 3-, 6-, and 12-months follow-ups. Additional aims include assessing others activation-related variables, craving, self-efficacy and withdrawal syndrome. This randomized controlled trial will be the first trial of Behavioural Activation and Smoking Cessation psychological treatment in a Spanish sample of seeking treatment smokers.

Official Title
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Behavioural Activation Treatment for Smoking Cessation and Depressive Symptomatology: a Randomized Controlled Trial

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: Standard cognitive-behavioural smoking cessation treatment
* Behavioral: Standard cognitive-behavioural smoking cessation treatment and behavioural activation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older who smoke at least 10 cigarettes per day Desire to participate voluntarily in the treatment offered to quit smoking Correctly fill out all the pretreatment assessment questionnaires Be able to provide written informed consent Exclusion Criteria: To have a diagnosis of a severe mental disorder (bipolar disorder and / or psychotic disorder) To have a substance use disorder (alcohol, cannabis, cocaine, heroin), different from a tobacco use disorder To smoke rolling snuff, cigars, little cigars or other tobacco products To have participated in an effective psychological treatment to quit smoking during the previous 12 months To have received other effective pharmacological treatment to quit smoking in the previous 12 months (nicotine gum or patches, bupropion, varenicline) To have a physical pathology involving life threatening risks for the person who would require immediate intervention in individual format (eg. Recent myocardial infarction, pneumothorax, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard cognitive-behavioural smoking cessation treatment<br> | Behavioral: Standard cognitive-behavioural smoking cessation treatment<br>* Standard cognitive-behavioural smoking cessation treatment is an effective treatment for tobacco dependence. The treatment elements are: treatment contract, self-report and graphic representation of cigarette consumption, information about tobacco, stimulus control, activities for the avoidance of withdrawal syndrome, physiological feedback (CO in expired air) on cigarette consumption, nicotine fading (change of cigarette brands each week progressively decreasing the intake of nicotine and tar), and relapse-prevention strategies (assertion training, problem solving training, change tobacco related misconceptions, management of anxiety and anger, exercise, weight control, self-reinforcing, and changing irrational beliefs). Treatment will be delivered in eight 60-minute sessions over 8 consecutive weeks.<br>|
| Active Comparator: Standard smoking cessation treatment and behavioral activation<br> | Behavioral: Standard cognitive-behavioural smoking cessation treatment and behavioural activation<br>* Behavioural activation will be applied along with standard cognitive-behavioural smoking cessation treatment. The treatment elements are: those present in the standard cognitive-behavioural smoking cessation treatment, plus analysis of the relationship between behaviour and mood, identification of situations and behaviours that decrease mood, identifying avoidance behaviours, and identifying thoughts of rumination and worry, self-report of pleasant daily activities, pleasant activity scheduling to increase engagement in rewarding activities, and to reduce patterns of behavioural avoidance. Treatment will be delivered in eight 60-minute sessions over 8 consecutive weeks.<br>|
| No Intervention: Control group<br>It will be a delayed treatment control group for a period of 3 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point-prevalence abstinence | Participants will be considered abstinent if they report abstinence, not even a puff of a cigarette, for ≥24 hours at the end of treatment (week 8 since beginning treatment), and for ≥7 days prior to follow up day at 3 months follow-up and have an expired carbon monoxide reading of ≤10 parts per million. At 6-, and 12-months follow-ups, participants will be considered abstinent if they report abstinence, not even a puff of a cigarette, for ≥30 days prior to follow up day and have an expired carbon monoxide reading of ≤10 parts per million. | 1 year | 
| Change from baseline in depressive symptoms on the Beck Depression Inventory-II (BDI-II) |  | 1 year | 
| Change from baseline in depressive symptoms on the Hamilton Depression Rating Scale |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous abstinence | According to the Russell Standard (West et al., 2005), participants will be considered abstinent if they report abstinence, have smoke not more than five cigarettes from the start of the abstinence period, and have an expired carbon monoxide reading of ≤10 parts per million | 1 year | 
| Reduction of cigarette consumption | Reduction of cigarette consumption by 50% or more between baseline and each follow-up will be calculated from the number of cigarettes smoked in the past 7 days at the end of treatment (week 8 since beginning treatment) and at 3 months follow-up. At 6-, and 12-months follow-ups it will be calculated from the number of cigarettes smoked in the past 30 days. | 1 year | 
| Change from baseline in the Environmental Reward Observation Scale (EROS) scores |  | 1 year | 
| Change from baseline in the Behavioural Activation for Depression Scale (BADS) scores |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, psychological treatment, depression