Smoking CessationNCT07021417
Effectiveness of Primary Care Nurse-supervised Educational Group Interventions for Giving up Smoking
A study testing Workshop and Course in people with Smoking Cessation, run by Universidad de Murcia at 1 site in Spain.
Trial summary
Background: To analyze the effectiveness of two group interventions for smoking cessa-tion (with support from the app) conducted by primary care nurses. Methods: A multi-center randomized controlled clinical trial occurred across eight Health Centres in the Murcia Region from 2018 to 2019. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Workshop and Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2018to 1 Feb 2021
- 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
- Daily smokers aged over 18 years.
- Smoking history of at least one year.
- Intention to quit smoking within one month.
- Ability to communicate in Spanish.
- Ownership of a mobile device with internet access.
Who cannot join
- Consumption of other drugs (excluding cannabis).
- Participation in smoking cessation programmes within the past year.
- Diagnosis of an acute psychotic disorder.
- Adolescents.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Primary Care Nurse-supervised Educational Group Interventions for Giving up Smoking: A Randomized Con-trolled Trial
Background: To analyze the effectiveness of two group interventions for smoking cessa-tion (with support from the app) conducted by primary care nurses. Methods: A multi-center randomized controlled clinical trial occurred across eight Health Centres in the Murcia Region from 2018 to 2019. It involved daily smokers aged 18 and older who wanted to quit, had internet access, and spoke Spanish. Pregnant women, polydrug users, and individuals with psychiatric disorders were excluded from participation. Participants were randomly divided into two groups: one attending a single 4-hour Workshop, and the other attending a Course consisting of four 2-hour sessions. The analysis of smoking abstinence was performed using SPSS V22, with intragroup differences assessed through the chi-square test.
Read the detailed description
The project was conceived as a randomised, multicentre clinical trial aimed at comparing the efficacy of two group-based intervention modalities for smoking cessation, both led by primary care nurses and supplemented by using the S'Acabó mobile application. The study was conducted in health centres across the Region of Murcia between 2018 and 2019, with participants being followed up for one year. The target population comprised adult smokers who expressed a desire to quit smoking, had internet access, and did not present with severe psychiatric disorders or concurrent substance use.
Allocation to the intervention groups was performed randomly: one group participated in a single four-hour workshop, whilst the other attended a course consisting of four weekly sessions, each lasting two hours. Both modalities incorporated cognitive-behavioural techniques and participatory methodologies to enhance individual motivation and group learning through the exchange of experiences and peer support.
The nurses responsible for delivering the interventions received specific training in smoking cessation, group education, and the management of group dynamics, thereby ensuring the standardisation and quality of the process. The study protocol included the systematic collection of sociodemographic, clinical, and tobacco consumption data, the assessment of psychological variables and the utilisation of complementary resources, including the mobile application. Follow-up of participants was conducted through face-to-face visits and telephone contacts at various points throughout the year, enabling the monitoring of the smoking cessation process and adherence to the proposed strategies. Statistical analysis of the data was carried out by international methodological standards, employing validated tools and ensuring the robustness and reliability of the results obtained.
- Conditions
- Smoking Cessation
- Being tested
- Workshop, Course
- Keywords
- Nurses, Nursing Evaluation Research, Primary Health Care, Smoking Cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WorkshopBehavioural
includes a single 4-hour session
CourseBehavioural
Includes four weekly sessions totaling 8 hours (2 hours each)
| Study group | Role | What they receive |
|---|---|---|
| Workshop | Experimental | Format:
A single group session of four hours' duration.
Structure:
All content and activities were concentrated into a single meeting.
Methodology:
Cognitive-behavioural techniques and participatory dynamics were employed, fostering motivation and vicarious learning among group members.
Focus:
The initial parts of the session were oriented towards preparing participants for smoking cessation, whilst the final segment focused on maintaining abstinence and preventing relapse.
Materials:
A standardised presentation and a procedural guide were utilised to ensure the homogeneity of the intervention.
Digital Support:
All participants received instructions on how to use the S'Acabó mobile application as a complement to the workshop. Receives: Behavioral: Workshop |
| Course | Experimental | Format:
A group programme comprising four weekly sessions of two hours each (eight hours in total).
Structure:
Sessions were distributed over the course of one month, allowing for a more gradual and sustained accompaniment.
Methodology:
Cognitive-behavioural techniques and participatory strategies were applied, facilitating the exchange of experiences and mutual support among participants.
Focus:
The first two sessions focused on preparation for smoking cessation, while the third and fourth sessions were dedicated to maintaining abstinence and preventing relapse.
Materials:
The same standardised materials and procedural guides as those used in the single workshop were employed.
Digital Support:
Use of the S'Acabó mobile application was also recommended as reinforcement for the content addressed in the face-to-face sessions. Receives: Behavioral: Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who are abstinent (self-reported abstinence corroborated by an exhaled carbon-monoxide reading, expressed in parts per million).
Assessment of effectiveness: Abstinence rates for the Course and the Workshop groups will be compared by means of the χ² test at 3-, 6-, 9- and 12-month follow-ups. Data will be analysed with SPSS v22; statistical significance will be set at p < 0.05.
Measured: Up to 12 months post-intervention (telephone contacts at months 3 and 9; face-to-face visits with carbon-monoxide testing at months 6 and 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start1 May 2018
- Primary completion1 Dec 2019
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adelaida Lozano-Polo, Phd, Principal investigator, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021417
- Sponsor's protocol ID
- 06052025
- Other IDs
- FFIS17/CE/01/26
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Primary Care Nurse-supervised Educational Group Interventions for Giving up Smoking: A Randomized Con-trolled Trial
- ClinicalTrials.gov ID
- NCT07021417
- Acronym / sponsor ID
- 06052025
- Conditions
- Smoking Cessation
- Keywords
- Nurses, Nursing Evaluation Research, Primary Health Care, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 15 Jun 2025 (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.
Background: To analyze the effectiveness of two group interventions for smoking cessa-tion (with support from the app) conducted by primary care nurses. Methods: A multi-center randomized controlled clinical trial occurred across eight Health Centres in the Murcia Region from 2018 to 2019. It involved daily smokers aged 18 and older who wanted to quit, had internet access, and spoke Spanish. Pregnant women, polydrug users, and individuals with psychiatric disorders were excluded from participation. Participants were randomly divided into two groups: one attending a single 4-hour Workshop, and the other attending a Course consisting of four 2-hour sessions. The analysis of smoking abstinence was performed using SPSS V22, with intragroup differences assessed through the chi-square test.
Detailed description
The project was conceived as a randomised, multicentre clinical trial aimed at comparing the efficacy of two group-based intervention modalities for smoking cessation, both led by primary care nurses and supplemented by using the S'Acabó mobile application. The study was conducted in health centres across the Region of Murcia between 2018 and 2019, with participants being followed up for one year. The target population comprised adult smokers who expressed a desire to quit smoking, had internet access, and did not present with severe psychiatric disorders or concurrent substance use.
Allocation to the intervention groups was performed randomly: one group participated in a single four-hour workshop, whilst the other attended a course consisting of four weekly sessions, each lasting two hours. Both modalities incorporated cognitive-behavioural techniques and participatory methodologies to enhance individual motivation and group learning through the exchange of experiences and peer support.
The nurses responsible for delivering the interventions received specific training in smoking cessation, group education, and the management of group dynamics, thereby ensuring the standardisation and quality of the process. The study protocol included the systematic collection of sociodemographic, clinical, and tobacco consumption data, the assessment of psychological variables and the utilisation of complementary resources, including the mobile application. Follow-up of participants was conducted through face-to-face visits and telephone contacts at various points throughout the year, enabling the monitoring of the smoking cessation process and adherence to the proposed strategies. Statistical analysis of the data was carried out by international methodological standards, employing validated tools and ensuring the robustness and reliability of the results obtained.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Workshop | Experimental | Behavioral: WorkshopFormat: A single group session of four hours' duration. Structure: All content and activities were concentrated into a single meeting. Methodology: Cognitive-behavioural techniques and participatory dynamics were employed, fostering motivation and vicarious learning among group members. Focus: The initial parts of the session were oriented towards preparing participants for smoking cessation, whilst the final segment focused on maintaining abstinence and preventing relapse. Materials: A standardised presentation and a procedural guide were utilised to ensure the homogeneity of the intervention. Digital Support: All participants received instructions on how to use the S'Acabó mobile application as a complement to the workshop. |
| Course | Experimental | Behavioral: CourseFormat: A group programme comprising four weekly sessions of two hours each (eight hours in total). Structure: Sessions were distributed over the course of one month, allowing for a more gradual and sustained accompaniment. Methodology: Cognitive-behavioural techniques and participatory strategies were applied, facilitating the exchange of experiences and mutual support among participants. Focus: The first two sessions focused on preparation for smoking cessation, while the third and fourth sessions were dedicated to maintaining abstinence and preventing relapse. Materials: The same standardised materials and procedural guides as those used in the single workshop were employed. Digital Support: Use of the S'Acabó mobile application was also recommended as reinforcement for the content addressed in the face-to-face sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Daily smokers aged over 18 years.
- Smoking history of at least one year.
- Intention to quit smoking within one month.
- Ability to communicate in Spanish.
- Ownership of a mobile device with internet access.
Key exclusion criteria (5 listed)
- Consumption of other drugs (excluding cannabis).
- Participation in smoking cessation programmes within the past year.
- Diagnosis of an acute psychotic disorder.
- Adolescents.
- Pregnant women.
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 |
|---|---|---|
| Workshopincludes a single 4-hour session | Behavioural | Workshop |
| CourseIncludes four weekly sessions totaling 8 hours (2 hours each) | Behavioural | Course |
Primary outcome
Proportion of participants who are abstinent (self-reported abstinence corroborated by an exhaled carbon-monoxide reading, expressed in parts per million).
Time frame: Up to 12 months post-intervention (telephone contacts at months 3 and 9; face-to-face visits with carbon-monoxide testing at months 6 and 12).
Assessment of effectiveness: Abstinence rates for the Course and the Workshop groups will be compared by means of the χ² test at 3-, 6-, 9- and 12-month follow-ups. Data will be analysed with SPSS v22; statistical significance will be set at p < 0.05.
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 15 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Adelaida Lozano-Polo, Phd principal investigator
Universidad de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Workshop and Course in people with Smoking Cessation, run by Universidad de Murcia 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 5 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 15 Jun 2025. 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?
Proportion of participants who are abstinent (self-reported abstinence corroborated by an exhaled carbon-monoxide reading, expressed in parts per million). (time frame: Up to 12 months post-intervention (telephone contacts at months 3 and 9; face-to-face visits with carbon-monoxide testing at months 6 and 12).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2025.