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Clinical Trials in Spain / NCT06900985
Starting soon Not applicable

Therapeutic Contact Intensity in a Psychological Smoking Cessation Intervention With an App

NCT06900985 · tracked via the Priya Life Science Spain tracker
Sponsor
University of Santiago de Compostela
Phase
Not applicable
Started
2026-09
Last updated
2026-04-28

Condition(s) studied

Smoking Behaviors

Investigational drug(s) / intervention(s)

8-sessions CBT + App4-sessions CBT+AppSmoking cessation App

8-sessions CBT + App: It 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: It 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: It will consist in the same App than the other two conditions. No therapeutic contact will be avaliable.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * aged 18 or over * wishing to participate in the treatment * providing written informed consent * smoking at least 5 cigarettes per day * completion of all pre-treatment assessment questionnaires * having a valid email address * having an Android or iOS smartphone and being willing to use it throughout the treatment Exclusion Criteria: * 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 * having completed a pharmacological treatment to quit smoking in the last year (any smoking cessation medication approved by the Agencia Española del Medicamento) * having a physical pathology involving high vital risk that requires immediate intervention (e.g., recent myocardial infarction) * having visual difficulties that prevent the use of the App.

Primary outcome measure(s)

  • 7-days point prevalence abstinence — At 12-months post-intervention
    The abstinent status will be defined as not having smoked in the last 7 days (not even a puff)

Trial sites (1)

FacilityCityRegionStatus
Smoking Cessation and Addictive Disorders Unit Santiago de Compostela A Coruña

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06900985 on ClinicalTrials.gov ↗ ← All trials in Spain