About this trial
This randomized controlled trial intends to examine the efficacy of a smoking cessation intervention with an App according to the intensity of therapeutic contact. Participants will be assigned to one of three groups. The first group will receive eight sessions with trained psychologists alongside access to the App. The second group will receive four sessions with trained psychologists plus App access. The control group will only have access to the App. This study seeks to determine the impact of different levels of therapeutic contact on abstinence outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
aged 18 or over
wishing to participate in the treatment
providing written informed consent
smoking at least 5 cigarettes per day
Disqualifiers
a diagnosis of severe mental disorder (bipolar disorder and/or psychotic disorder)
concurrent substance use disorder (alcohol, cannabis, stimulant, hallucinogen and/or opioid)
using other tobacco products (electronic cigarette with nicotine, cigars or cigarillos)
having completed an effective psychological treatment to quit smoking during the previous year
Trial design
Parallel
Treatments tested in this trial
8-sessions CBT + App
BehavioralIt will consist of 8 one-hour sessions applied in group format once a week and participants will be followed at 3, 6, and 12 months. The sessions will be conducted by clinical psychology/general health psychology professionals and will be carried out using video calls. The smoking cessation treatment follows a cognitive-behavioral approach with components for anhedonia reduction, increased physical activity and positive social support, being a modified, multidisciplinary, and extended version of the original smoking cessation program (Becoña, 2007; Becoña et al., 2017). The treatment will be complemented with an App with active therapeutic components that participants will use during treatment and the one-year follow-up period.
4-sessions CBT+App
BehavioralIt will consist of 4 one-hour sessions applied in group format every two-weeks (8 weeks total duration) and participants will be followed at 3, 6, and 12 months. The sessions will be conducted by clinical psychology/general health psychology professionals and will be carried out using video calls. The 4 sessions will have the following content: 1) explanation of treatment rationale and components available in the App; 2) participants' progress monitoring, reinforcement of achieved goals, and analysis of difficulties; 3) cessation planning support; and 4) relapse prevention support. The treatment sessions will be protocolized in a treatment manual. The treatment will be complemented with the same App that the other conditions
Smoking cessation App
BehavioralIt will consist in the same App than the other two conditions. No therapeutic contact will be avaliable.
Treatment groups
Trial outcomes
Primary outcomes
7-days point prevalence abstinence
The abstinent status will be defined as not having smoked in the last 7 days (not even a puff)
Secondary outcomes
7-days point prevalence
The abstinent status will be defined as not having smoked in the last 7 days (not even a puff)
7-days point prevalence abstinence
The abstinent status will be defined as not having smoked in the last 7 days (not even a puff)
Satisfaction with the intervention
Scores obtained in Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 19979; Spanish version of Vázquez et al., 2017)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: