Smoking BehaviorsTREATINTSMOKENCT06900985
Therapeutic Contact Intensity in a Psychological Smoking Cessation Intervention With an App
A study testing 8-sessions CBT + App, 4-sessions CBT+App and Smoking cessation App in people with Smoking Behaviors, run by University of Santiago de Compostela at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Behaviors
- What is being tested?
- 8-sessions CBT + App, 4-sessions CBT+App and Smoking cessation App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 429 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2026to Apr 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Smoking Cessation and Addictive Disorders Unit
Santiago de Compostela, A Coruña, 15885
Ana Lopez Duran, Phd, +34 881813939, unidad.tabaquismo@usc.gal
About this study
Official title: Assessment of a Psychological Treatment for Smoking Cessation Combined With an App According to the Intensity of Therapeutic Contact: Randomized Controlled 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.
Read the detailed description
Smoking remains the leading preventable cause of morbidity and mortality worldwide. It is crucial to implement preventive measures to reduce the likelihood of people starting to smoke but also to make effective smoking cessation treatments available to those who smoke. Psychological interventions have proven to be effective to quit smoking and are considered first-choice interventions, especially for specific populations such as adolescents or pregnant women . The motivation behind this proposal is to improve the effectiveness of smoking cessation treatments based on our clinical and research experience in smoking cessation psychological interventions. Although we have very effective psychological treatments, producing abstinence rates of approximately 70% at the end of the treatment, and 35% at one year of follow-up to continue improving its effectiveness and reduce relapse rates is warranted. Furthermore, technological advances can help increase accessibility to available treatments and motivation to participate in smoking cessation interventions.
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
- Smoking Behaviors
- Being tested
- 8-sessions CBT + App, 4-sessions CBT+App, Smoking cessation App
- Keywords
- smoking, treatment, cognitive-behavioral, therapeutic-contact intensity, digital intervention, eHealth, randomized controlled trial
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-sessions CBT + AppBehavioural
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+AppBehavioural
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 AppBehavioural
It will consist in the same App than the other two conditions. No therapeutic contact will be avaliable.
| Study group | Role | What they receive |
|---|---|---|
| 1. High-intensity therapeutic contact cognitive-behavioral treatment for smoking cessation with App | Active comparator | 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. Receives: Behavioral: 8-sessions CBT + App |
| 2. Medium-intensity therapeutic contact CBT for smoking cessation with App | Active comparator | 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. Receives: Behavioral: 4-sessions CBT+App |
| 3. App only (no therapeutic-contact group). | Active comparator | It will consist of the same App than participants assigned to Conditions 1 and 2, but without contact with professionals Receives: Behavioral: Smoking cessation App |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-days point prevalence abstinence
The abstinent status will be defined as not having smoked in the last 7 days (not even a puff)
Measured: At 12-months post-intervention
Secondary outcomes (3)
7-days point prevalence
The abstinent status will be defined as not having smoked in the last 7 days (not even a puff)
Measured: At 3 and 6-months post-intervention
7-days point prevalence abstinence
The abstinent status will be defined as not having smoked in the last 7 days (not even a puff)
Measured: At 7-days post-quit day
Satisfaction with the intervention
Scores obtained in Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 19979; Spanish version of Vázquez et al., 2017)
Measured: At 8-weeks after beginning the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Sep 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 429 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana López Durán, University of Santiago de Compostela
- Investigators
- Ana López-Durán, Phd., Principal investigator, University of Santiago de CompostelaElisardo Becoña Iglesias, Phd., Principal investigator, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900985
- Sponsor's protocol ID
- PID2023-146663OB-I00
- Acronym
- TREATINTSMOKE
- Status last verified
- Oct 2026
- First submitted
- 21 Mar 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lopez-Duran A, Martinez-Vispo C, Martinez U, Rodriguez-Cano R, Cortes-Garcia L, Miguez MC, Barroso-Hurtado M, Ramos-Carro M, Moss-Alonso E, Vacas J, Millara L, Tubio A, Becona E. Therapeutic contact intensity as an adjunct to a cognitive behavioral smoking cessation app: protocol for a randomized controlled trial. Addict Sci Clin Pract. 2026 Jun 11. doi: 10.1186/s13722-026-00684-0. Online ahead of print.
PubMed 42271518