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NCT06900985
Therapeutic Contact Intensity in a Psychological Smoking Cessation Intervention With an App
Conditions: Smoking Behaviors
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 429
Sponsor: University of Santiago de Compostela
Location: Smoking Cessation and Addictive Disorders Unit Santiago de Compostela A Coruña
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 Criteria
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.
Source: ClinicalTrials.gov (NCT06900985). StuddyBuddy aggregates publicly available trial information.