Therapeutic Contact Intensity in a Psychological Smoking Cessation Intervention With an App
NCT ID: NCT06900985
Last Updated: 2025-04-03
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
429 participants
INTERVENTIONAL
2025-10-31
2028-04-30
Brief Summary
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Detailed Description
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The main objective of this proposal is to assess the efficacy of a cognitive-behavioral treatment for smoking cessation with new components (anhedonia and mood management, physical activity, and positive social support) according to the intensity of the therapeutic contact, through a randomized controlled trial. The treatment will be conducted through video call format to make it more accessible. The study will compare three groups that will receive treatments of varying intensity of therapeutic contact: 1) 8 intervention sessions + App (Experimental Group 1, EG1), 2) 4 intervention sessions + App (Experimental Group 2, G2), and 3) no therapeutic contact, App only (control group/CG). Our initial hypothesis is that the higher intensity intervention (EG1) will be more effective than EG2 and CG groups in abstinence outcomes at the end of the intervention and in reducing relapse rates for one year follow-up. The EG2 will be more effective than the CG in abstinence outcomes at the end of the intervention and in reducing relapse rates during one-year follow-up.
Digital treatment delivery formats will be used to increase treatment accessibility: 1) treatment sessions will be conducted through video calls which will remove geographical and time-related barriers. This format will be particularly useful for smokers experiencing barriers to access to treatment due to work/family schedules; 2) a smoking cessation App will be used to improve adherence and access to treatment components anytime, anywhere. Moreover, integrating technology into the treatment can facilitate participants intersessions tasks and support the work of professionals. Our previous experience with an App as a complement to the smoking cessation intervention showed excellent abstinence outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1. High-intensity therapeutic contact cognitive-behavioral treatment for smoking cessation with App
It will consist of an App and 8 one-hour sessions applied in group format once a week (8 weeks total duration). The sessions will be conducted by trained clinical psychology/general health psychology professionals and will be carried out using video calls.
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.
2. Medium-intensity therapeutic contact CBT for smoking cessation with App
It will consist of an App and 4 one-hour sessions applied in group format every two-weeks (8 weeks total duration). The sessions will be conducted by trained clinical psychology/general health psychology professionals and will be carried out using video calls.
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
3. App only (no therapeutic-contact group).
It will consist of the same App than participants assigned to Conditions 1 and 2, but without contact with professionals
Smoking cessation App
It will consist in the same App than the other two conditions. No therapeutic contact will be avaliable.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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University of Santiago de Compostela
OTHER
Responsible Party
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Ana López Durán
Phd in Clinical Psychology and Psychobiology/Associated Professor
Principal Investigators
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Ana López-Durán, Phd.
Role: PRINCIPAL_INVESTIGATOR
University of Santiago de Compostela
Elisardo Becoña Iglesias, Phd.
Role: PRINCIPAL_INVESTIGATOR
University of Santiago de Compostela
Locations
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Smoking Cessation and Addictive Disorders Unit
Santiago de Compostela, A Coruña, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Lopez-Duran A, Martinez-Vispo C, Barroso-Hurtado M, Suarez-Castro D, Becona E. Incorporating technology in smoking cessation interventions: In-person vs. Video-call formats. Int J Med Inform. 2025 Mar;195:105774. doi: 10.1016/j.ijmedinf.2024.105774. Epub 2024 Dec 24.
Martinez-Vispo C, Rodriguez-Cano R, Lopez-Duran A, Senra C, Fernandez Del Rio E, Becona E. Cognitive-behavioral treatment with behavioral activation for smoking cessation: Randomized controlled trial. PLoS One. 2019 Apr 8;14(4):e0214252. doi: 10.1371/journal.pone.0214252. eCollection 2019.
Lopez-Duran A, Martinez-Vispo C, Suarez-Castro D, Barroso-Hurtado M, Becona E. The Efficacy of the SinHumo App Combined With a Psychological Treatment to Quit Smoking: A Randomized Clinical Trial. Nicotine Tob Res. 2025 Feb 24;27(3):429-437. doi: 10.1093/ntr/ntae053.
Patnode CD, Henderson JT, Coppola EL, Melnikow J, Durbin S, Thomas RG. Interventions for Tobacco Cessation in Adults, Including Pregnant Persons: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2021 Jan 19;325(3):280-298. doi: 10.1001/jama.2020.23541.
Other Identifiers
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PID2023-146663OB-I00
Identifier Type: -
Identifier Source: org_study_id
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