SmokingNCT04765813
Use of a Smartphone Application (App) to Assist a Cognitive-Behavioral Smoking Cessation Treatment
A study testing Cognitive-behavioral treatment to quit smoking along with an App with active therapeutic components in people with Smoking, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
This randomized controlled clinical trial examines the effectiveness of a face-to-face* cognitive-behavioral behavioral treatment to quit smoking enriched with an App. This project aims to innovate in the psychological smoking cessation treatment and increase abstinence rates in the short and long term. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- Cognitive-behavioral treatment to quit smoking along with an App with active therapeutic components
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2021to 10 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older who smoke at least 8 cigarettes per day
- Desire to participate voluntarily in the treatment offered to quit smoking
- Correctly fill out all the pretreatment assessment questionnaires
- Be able to provide written informed consent
- Currently own a valid email and a smartphone Android or iOS and willing to use it during treatment
Who cannot join
- To have a diagnosis of a severe mental disorder (bipolar disorder and/or psychotic disorder)
- To have a substance use disorder (alcohol, cannabis, cocaine, heroin), different from a tobacco use disorder
- To smoke rolling snuff, cigars, little cigars, or other tobacco products
- To have participated in an effective psychological treatment to quit smoking during the previous 12 months
- To have received other effective pharmacological treatment to quit smoking in the previous 12 months (nicotine gum or patches, bupropion, varenicline)
- To have a physical pathology involving life-threatening risks for the person who would require immediate intervention in individual format (e.g., recent myocardial infarction, pneumothorax)
- To have a visual impairment that impedes the use of the App
Trial locations and contacts
1 site in 1 country.
Spain1 site
Smoking Cessation and Addictive Disorders Unit, Faculty of Psychology, University of Santiago de Compostela
Santiago de Compostela, A Coruña, 15782
About this study
Official title: A Randomized Clinical Trial to Assess the Efficacy of a Psychological Treatment to Quit Smoking Assisted With an App
This randomized controlled clinical trial examines the effectiveness of a face-to-face* cognitive-behavioral behavioral treatment to quit smoking enriched with an App. This project aims to innovate in the psychological smoking cessation treatment and increase abstinence rates in the short and long term.
- Due to the COVID-19 the face-to-face treatment will be conducted in an online format.
Read the detailed description
Psychological treatment (cognitive-behavioral) is a first-line smoking cessation treatment that has proven its efficacy. However, it is necessary to continue investigating to improve smoking outcomes as abstinence and reduce relapse rates. The use of information technologies (ICTs) in the field of health has grown and developed significantly in recent years. Specifically, mobile applications (Apps), aimed at different health-related aspects (mHealth Apps), are a valuable resource. Its use, as a complement to the face-to-face treatment, could help to increase motivation to quit smoking, treatment adherence, and therapeutic activities compliance.
mHealth Apps are becoming highly relevant due to their cost-effectiveness and the added attractiveness for many users. Considering this context, the main aim of the present project is to design and assess the efficacy of a cognitive-behavioral treatment (CBT) for smoking cessation enriched with a Smartphone App.
A randomized clinical trial will be carried out with a sample of 270 treatment-seeking smokers at the Smoking Cessation and Addictive Disorders Unit of the University of Santiago de Compostela. Participants will be randomly assigned to one of the following groups:
- The experimental group (CBT + App), in which participants will receive a cognitive-behavioral treatment* to quit smoking along with an App with active therapeutic components during the treatment and 12 months follow-ups period (n = 135)
- The control group (CBT), in which participants will receive the same cognitive-behavioral treatment* along with the use of a Control App (without active components) during the treatment (n = 135).
The main hypothesis is that the combination of a cognitive-behavioral psychological treatment to quit smoking and an App with active therapeutic components will obtain higher abstinence rates at the end of treatment and the 12-month follow-up period, compared to the control group
- Due to the COVID-19, the face-to-face cognitive-behavioral treatment will be conducted in an online format
- Conditions
- Smoking
- Being tested
- Cognitive-behavioral treatment to quit smoking along with an App with active therapeutic components, Cognitive-behavioral treatment to quit smoking along with a control App
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral treatment to quit smoking along with an App with active therapeutic componentsBehavioural
Cognitive-behavioral smoking cessation treatment components will be: treatment contract, self-report and graphic representation of cigarette consumption, information about tobacco, stimulus control, activities for the avoidance of withdrawal syndrome, physiological feedback (CO in expired air) on cigarette consumption, nicotine fading (change of cigarette brands each week progressively decreasing the intake of nicotine and tar), and relapse-prevention strategies (assertion training, problem-solving training, change tobacco-related misconceptions, management of anxiety and anger, exercise, weight control, self-reinforcing, and changing irrational beliefs).
Participants will use a smartphone App with therapeutic components during the intervention (8 weeks) and follow-up period (time frame: one year).
Cognitive-behavioral treatment to quit smoking along with a control AppBehavioural
Cognitive-behavioral smoking cessation treatment components will be: treatment contract, self-report and graphic representation of cigarette consumption, information about tobacco, stimulus control, activities for the avoidance of withdrawal syndrome, physiological feedback (CO in expired air) on cigarette consumption, nicotine fading (change of cigarette brands each week progressively decreasing the intake of nicotine and tar), and relapse-prevention strategies (assertion training, problem-solving training, change tobacco-related misconceptions, management of anxiety and anger, exercise, weight control, self-reinforcing, and changing irrational beliefs).
Participants will use a control smartphone App (only to access session materials) during the intervention period (8 weeks).
| Study group | Role | What they receive |
|---|---|---|
| CBT and active smartphone mobile application | Experimental | Participants receive a cognitive-behavioral treatment to quit smoking along with an App with active therapeutic components Receives: Behavioral: Cognitive-behavioral treatment to quit smoking along with an App with active therapeutic components |
| CBT and control smartphone mobile application | Active comparator | Participants receive a cognitive-behavioral treatment to quit smoking along with a control App Receives: Behavioral: Cognitive-behavioral treatment to quit smoking along with a control App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point-prevalence abstinence
Participants will be considered abstinent if they report abstinence, not even a puff of a cigarette, for ≥7 days at the end of treatment (week 8 since beginning treatment), and prior to follow-up day at 3-, 6-, and 12-months follow-up.
Measured: 1 year
Secondary outcomes (2)
Continuous abstinence
Self-reported 30-day point prevalence abstinence at 3-, 6-, and 12-month follow-up
Measured: 1 year
Reduction of cigarette consumption (cigarettes per day)
Reduction of cigarette consumption between baseline and each follow-up will be calculated from the number of cigarettes smoked in the past 7 days at the end of treatment (week 8 since beginning treatment) and at 3-, 6-, and 12-months follow-up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start15 Sep 2021
- Primary completion10 Nov 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies 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
- Participant
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Principal investigator, Elisardo Becoña Iglesias, University of Santiago de Compostela
- Investigators
- Elisardo Becoña, PhD, Principal investigator, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765813
- Sponsor's protocol ID
- PID2019-109400RB-I00
- Status last verified
- Nov 2023
- First submitted
- 16 Feb 2021
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopez-Duran A, Becona E, Senra C, Suarez-Castro D, Barroso-Hurtado M, Martinez-Vispo C. A Randomized Clinical Trial to Assess the Efficacy of a Psychological Treatment to Quit Smoking Assisted with an App: Study Protocol. Int J Environ Res Public Health. 2022 Aug 8;19(15):9770. doi: 10.3390/ijerph19159770.
PubMed 35955123Lopez-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.
PubMed 39742855
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Assess the Efficacy of a Psychological Treatment to Quit Smoking Assisted With an App
- ClinicalTrials.gov ID
- NCT04765813
- Acronym / sponsor ID
- PID2019-109400RB-I00
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled clinical trial examines the effectiveness of a face-to-face* cognitive-behavioral behavioral treatment to quit smoking enriched with an App. This project aims to innovate in the psychological smoking cessation treatment and increase abstinence rates in the short and long term.
- Due to the COVID-19 the face-to-face treatment will be conducted in an online format.
Detailed description
Psychological treatment (cognitive-behavioral) is a first-line smoking cessation treatment that has proven its efficacy. However, it is necessary to continue investigating to improve smoking outcomes as abstinence and reduce relapse rates. The use of information technologies (ICTs) in the field of health has grown and developed significantly in recent years. Specifically, mobile applications (Apps), aimed at different health-related aspects (mHealth Apps), are a valuable resource. Its use, as a complement to the face-to-face treatment, could help to increase motivation to quit smoking, treatment adherence, and therapeutic activities compliance.
mHealth Apps are becoming highly relevant due to their cost-effectiveness and the added attractiveness for many users. Considering this context, the main aim of the present project is to design and assess the efficacy of a cognitive-behavioral treatment (CBT) for smoking cessation enriched with a Smartphone App.
A randomized clinical trial will be carried out with a sample of 270 treatment-seeking smokers at the Smoking Cessation and Addictive Disorders Unit of the University of Santiago de Compostela. Participants will be randomly assigned to one of the following groups:
- The experimental group (CBT + App), in which participants will receive a cognitive-behavioral treatment* to quit smoking along with an App with active therapeutic components during the treatment and 12 months follow-ups period (n = 135)
- The control group (CBT), in which participants will receive the same cognitive-behavioral treatment* along with the use of a Control App (without active components) during the treatment (n = 135).
The main hypothesis is that the combination of a cognitive-behavioral psychological treatment to quit smoking and an App with active therapeutic components will obtain higher abstinence rates at the end of treatment and the 12-month follow-up period, compared to the control group
- Due to the COVID-19, the face-to-face cognitive-behavioral treatment will be conducted in an online format
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT and active smartphone mobile application | Experimental | Behavioral: Cognitive-behavioral treatment to quit smoking along with an App with active therapeutic componentsParticipants receive a cognitive-behavioral treatment to quit smoking along with an App with active therapeutic components |
| CBT and control smartphone mobile application | Active comparator | Behavioral: Cognitive-behavioral treatment to quit smoking along with a control AppParticipants receive a cognitive-behavioral treatment to quit smoking along with a control App |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older who smoke at least 8 cigarettes per day
- Desire to participate voluntarily in the treatment offered to quit smoking
- Correctly fill out all the pretreatment assessment questionnaires
- Be able to provide written informed consent
- Currently own a valid email and a smartphone Android or iOS and willing to use it during treatment
Key exclusion criteria (7 listed)
- To have a diagnosis of a severe mental disorder (bipolar disorder and/or psychotic disorder)
- To have a substance use disorder (alcohol, cannabis, cocaine, heroin), different from a tobacco use disorder
- To smoke rolling snuff, cigars, little cigars, or other tobacco products
- To have participated in an effective psychological treatment to quit smoking during the previous 12 months
- To have received other effective pharmacological treatment to quit smoking in the previous 12 months (nicotine gum or patches, bupropion, varenicline)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral treatment to quit smoking along with an App with active therapeutic componentsCognitive-behavioral smoking cessation treatment components will be: treatment contract, self-report and graphic representation of cigarette consumption, information about tobacco, stimulus control, activities for the avoidance of withdrawal syndrome, physiological feedback (CO in expired air) on cigarette consumption, nicotine fading (change of cigarette brands each week progressively decreasing the intake of nicotine and tar), and relapse-prevention strategies (assertion training, problem-solving training, change tobacco-related misconceptions, management of anxiety and anger, exercise, weight control, self-reinforcing, and changing irrational beliefs). Participants will use a smartphone App with therapeutic components during the intervention (8 weeks) and follow-up period (time frame: one year). | Behavioural | CBT and active smartphone mobile application |
| Cognitive-behavioral treatment to quit smoking along with a control AppCognitive-behavioral smoking cessation treatment components will be: treatment contract, self-report and graphic representation of cigarette consumption, information about tobacco, stimulus control, activities for the avoidance of withdrawal syndrome, physiological feedback (CO in expired air) on cigarette consumption, nicotine fading (change of cigarette brands each week progressively decreasing the intake of nicotine and tar), and relapse-prevention strategies (assertion training, problem-solving training, change tobacco-related misconceptions, management of anxiety and anger, exercise, weight control, self-reinforcing, and changing irrational beliefs). Participants will use a control smartphone App (only to access session materials) during the intervention period (8 weeks). | Behavioural | CBT and control smartphone mobile application |
Primary outcome
Point-prevalence abstinence
Time frame: 1 year
Participants will be considered abstinent if they report abstinence, not even a puff of a cigarette, for ≥7 days at the end of treatment (week 8 since beginning treatment), and prior to follow-up day at 3-, 6-, and 12-months follow-up.
2 secondary outcomes
Continuous abstinence
Time frame: 1 year
Reduction of cigarette consumption (cigarettes per day)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 35955123Lopez-Duran A, Becona E, Senra C, Suarez-Castro D, Barroso-Hurtado M, Martinez-Vispo C. A Randomized Clinical Trial to Assess the Efficacy of a Psychological Treatment to Quit Smoking Assisted with an App: Study Protocol. Int J Environ Res Public Health. 2022 Aug 8;19(15):9770. doi: 10.3390/ijerph19159770.
- Derived from this study: PubMed 39742855Lopez-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.
- Individual participant dataSharing planned: No
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisardo Becoña, PhD principal investigator
University of Santiago de Compostela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral treatment to quit smoking along with an App with active therapeutic components in people with Smoking, run by University of Santiago de Compostela at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point-prevalence abstinence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04765813, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.