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CompletedNCT07021417Updated Jun 15, 2025

Effectiveness of Primary Care Nurse-supervised Educational Group Interventions for Giving up Smoking

An interventional study of Workshop and Course in Smoking Cessation, sponsored by Universidad de Murcia. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-15.

Sponsored by Universidad de Murcia · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 7 years after the study started (first participant enrolled May 2018, registered May 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Smoking Cessation

Keywords

  • Nurses
  • Nursing Evaluation Research
  • Primary Health Care
  • Smoking Cessation
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In context

Lead sponsor

Universidad de Murcia is the lead sponsor of 77 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria:

  • Consumption of other drugs (excluding cannabis).
  • Participation in smoking cessation programmes within the past year.
  • Diagnosis of an acute psychotic disorder.
  • Adolescents.
  • Pregnant women.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
83 participants (actual)

Study arms

  • Experimental
    Workshop

    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.

    Behavioral: Workshop

  • Experimental
    Course

    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.

    Behavioral: Course

Interventions

  • BehavioralWorkshop

    includes a single 4-hour session

  • BehavioralCourse

    Includes four weekly sessions totaling 8 hours (2 hours each)

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What researchers measure

Primary outcomes

  1. 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.

    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).

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Study locations

1 site
  • Faculty of Nursing
    Cartagena, Murcia 30203, Spain
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References and documents

Study documents

  • Study protocol · May 4, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07021417
Lead sponsor
Universidad de Murcia
Responsible party
Sponsor
First posted
Jun 15, 2025
Start date
May 1, 2018
Primary completion
Dec 1, 2019
Completion
Feb 1, 2021
Last update
Jun 15, 2025

Study contacts

Adelaida Lozano-Polo, Phd
principal investigator · Universidad de Murcia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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