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

NCT02844595 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2018-10-10

No results posted yet for this study

Summary

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.

Conditions

  • Smoking

Interventions

BEHAVIORAL

Standard cognitive-behavioural smoking cessation treatment

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.

BEHAVIORAL

Standard cognitive-behavioural smoking cessation treatment and behavioural activation

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.

Sponsors & Collaborators

  • University of Santiago de Compostela

    lead OTHER

Principal Investigators

  • Elisardo Becoña · University of Santiago de Compostela

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02844595 on ClinicalTrials.gov