CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 275 enrolled
Drug / intervention
Standard cognitive-behavioural smoking cessation treatment +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02844595
NCT02844595N/ACompleted

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

University of Santiago de Compostela·interventional·Posted Jul 26, 2016·Updated Oct 10, 2018

In Brief

A clinical study evaluating Standard cognitive-behavioural smoking cessation treatment and Standard cognitive-behavioural smoking cessation treatment and behavioural activation for Smoking. Completed, enrolled 275 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 26, 2016
Enrollment StartJan 1, 2016
Primary CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.9 years ago

Interventions

Standard cognitive-behavioural smoking cessation treatmentbehavioral

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.

Standard cognitive-behavioural smoking cessation treatment and behavioural activationbehavioral

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.