Smoking CessationPOLSISNCT06945770
Web-based Smoking Intervention as an add-on to Routine Smoking Cessation Clinical Treatment
A study testing POLSIS and routine service delivery(Nicotine Replacement Theraphy, Cytisine) in people with Smoking Cessation, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated the effectiveness of an online psycho-education program offered in addition to routine care for individuals attending a smoking cessation clinic. Conducted as a randomized controlled trial, the study assigned 103 participants to the intervention group and 105 to the control group. 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?
- POLSIS and routine service delivery(Nicotine Replacement Theraphy, Cytisine)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 1 Jan 2025
- 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
- using internet
- being a volunteer
Who cannot join
- not using internet
- not being a volunteer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Web-based Smoking Intervention as an add-on to Routine Smoking Cessation Clinical Treatment: a Randomized Controlled Trial
This study evaluated the effectiveness of an online psycho-education program offered in addition to routine care for individuals attending a smoking cessation clinic. Conducted as a randomized controlled trial, the study assigned 103 participants to the intervention group and 105 to the control group. Based on follow-up data, analyses were carried out with 37 participants from the intervention group and 24 from the control group. Primary Hypotheses
Among individuals who applied to the Smoking Cessation Outpatient Clinic at the Institute on Drug Abuse, Toxicology, and Pharmaceutical Science, Ege University, those who receive additional online psychoeducational support integrated into the outpatient service are expected to:
Read more
H1: Be more successful in quitting smoking compared to those who do not receive this support.
H2: Be more successful in reducing the number of cigarettes smoked per day. H3: Show a significant change in their level of nicotine dependence.
Secondary Hypotheses H4: Show significant progress in the stages of change regarding smoking behavior.
H5: Show significant improvement in their mental well-being.
Read the detailed description
Abstract Determination of Effectiveness of Online Psycho-education Embedded in Routine Service Delivery for Smoking Cessation: a Randomized Controlled Trial Objective: This study aims to evaluate the effectiveness of online psychoeducation provided in addition to routine treatment in a smoking cessation clinic compared to routine treatment alone.
Method: The study is a single-center, single-blind, randomized controlled experimental trial conducted between May 2024 and January 2025 at the Smoking Cessation Clinic of the Ege University Institute on Substance Abuse, Toxicology, and Pharmaceutical Sciences. Participants were randomly assigned to the intervention (n=103) and control (n=105) groups in a 1:1 ratio. During the study, the Warwick-Edinburgh Mental Well-being Scale Short Form (WEMWBS-SF), the Fagerström Nicotine Dependence Test (FNBT), and a case information form including HAPA stages of change were administered. The primary outcomes of this study are cigarette consumption, FNBT score, and smoking cessation success. The secondary outcomes include the HAPA stage of change and mental well-being score. Confounding variables considered in the study include education level, age, gender, employment status, mental health issues, marital status, and smoking cessation attempt. Based on follow-up data, analyses were conducted using data from 37 participants in the intervention group and 24 in the control group. Data analysis included paired and independent samples t-tests, chi-square analysis, one-way ANOVA, and linear and logistic regression analysis.
- Conditions
- Smoking Cessation
- Being tested
- POLSIS, routine service delivery(Nicotine Replacement Theraphy, Cytisine)
- Keywords
- tobacco use disorder, smoking cessation, web-based psycho-education
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POLSISBehavioural
web based smoking cessation psycho-education
routine service delivery(Nicotine Replacement Theraphy, Cytisine)Drug
routine smoking cessation service delivery
| Study group | Role | What they receive |
|---|---|---|
| POLSIS | Experimental | web based smoking cessation psycho-education Receives: Behavioral: POLSIS; Drug: routine service delivery(Nicotine Replacement Theraphy, Cytisine) |
| control | Active comparator | routine service delivery Receives: Drug: routine service delivery(Nicotine Replacement Theraphy, Cytisine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Fagerström Test for Nicotine Dependence (FTND) scores
Nicotine dependence was assessed using the Fagerström Test for Nicotine Dependence (FTND), a standardized scale ranging from 0 to 10, with higher scores indicating a greater level of nicotine dependence.
Measured: from enrollment to the end of the treatment at 4 weeks
number of cigarettes smoked
number of cigarettes smoked on each day
Measured: from enrollment to the end of the treatment at 4 weeks
smoking cessation
smoking less than 5 cigarettes
Measured: from enrollment to the end of the treatment at 4 weeks
Secondary outcomes (2)
mental well being score
The Short Form of the Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) consists of 7 items, each assessing positive feelings and thoughts experienced over the past two weeks. Participants rate how often they have experienced each statement during this period on a scale from 1 to 5 (1 = None of the time, 5 = All of the time). Higher scores indicate better mental well-being.
Measured: from enrollment to the end of the treatment at 4 weeks
HAPA stage
HAPA stage of change (from 1 to 4)
(1: I am not thinking about quitting smoking. 2:I am considering quitting smoking. 3:I am seriously thinking about quitting smoking. 4:I have already quit smoking.)
Measured: from enrollment to the end of the treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 May 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
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.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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, Investigator
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, duygu altin, Ege University
- Investigators
- duygu altin, phd, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945770
- Sponsor's protocol ID
- 23-4.1T/26
- Other IDs
- 29724
- Acronym
- POLSIS
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 25 Apr 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 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Smoking Intervention as an add-on to Routine Smoking Cessation Clinical Treatment: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06945770
- Acronym / sponsor ID
- POLSIS / 23-4.1T/26
- Conditions
- Smoking Cessation
- Keywords
- tobacco use disorder, smoking cessation, web-based psycho-education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 25 Apr 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.
This study evaluated the effectiveness of an online psycho-education program offered in addition to routine care for individuals attending a smoking cessation clinic. Conducted as a randomized controlled trial, the study assigned 103 participants to the intervention group and 105 to the control group. Based on follow-up data, analyses were carried out with 37 participants from the intervention group and 24 from the control group. Primary Hypotheses
Among individuals who applied to the Smoking Cessation Outpatient Clinic at the Institute on Drug Abuse, Toxicology, and Pharmaceutical Science, Ege University, those who receive additional online psychoeducational support integrated into the outpatient service are expected to:
H1: Be more successful in quitting smoking compared to those who do not receive this support.
H2: Be more successful in reducing the number of cigarettes smoked per day. H3: Show a significant change in their level of nicotine dependence.
Secondary Hypotheses H4: Show significant progress in the stages of change regarding smoking behavior.
H5: Show significant improvement in their mental well-being.
Detailed description
Abstract Determination of Effectiveness of Online Psycho-education Embedded in Routine Service Delivery for Smoking Cessation: a Randomized Controlled Trial Objective: This study aims to evaluate the effectiveness of online psychoeducation provided in addition to routine treatment in a smoking cessation clinic compared to routine treatment alone.
Method: The study is a single-center, single-blind, randomized controlled experimental trial conducted between May 2024 and January 2025 at the Smoking Cessation Clinic of the Ege University Institute on Substance Abuse, Toxicology, and Pharmaceutical Sciences. Participants were randomly assigned to the intervention (n=103) and control (n=105) groups in a 1:1 ratio. During the study, the Warwick-Edinburgh Mental Well-being Scale Short Form (WEMWBS-SF), the Fagerström Nicotine Dependence Test (FNBT), and a case information form including HAPA stages of change were administered. The primary outcomes of this study are cigarette consumption, FNBT score, and smoking cessation success. The secondary outcomes include the HAPA stage of change and mental well-being score. Confounding variables considered in the study include education level, age, gender, employment status, mental health issues, marital status, and smoking cessation attempt. Based on follow-up data, analyses were conducted using data from 37 participants in the intervention group and 24 in the control group. Data analysis included paired and independent samples t-tests, chi-square analysis, one-way ANOVA, and linear and logistic regression analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POLSIS | Experimental | Behavioral: POLSIS, Drug: routine service delivery(Nicotine Replacement Theraphy, Cytisine)web based smoking cessation psycho-education |
| control | Active comparator | Drug: routine service delivery(Nicotine Replacement Theraphy, Cytisine)routine service delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- using internet
- being a volunteer
Key exclusion criteria (2 listed)
- not using internet
- not being a volunteer
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 |
|---|---|---|
| POLSISweb based smoking cessation psycho-education | Behavioural | POLSIS |
| routine service delivery(Nicotine Replacement Theraphy, Cytisine)routine smoking cessation service delivery | Drug | POLSIS, control |
Primary outcome
the Fagerström Test for Nicotine Dependence (FTND) scores
Time frame: from enrollment to the end of the treatment at 4 weeks
Nicotine dependence was assessed using the Fagerström Test for Nicotine Dependence (FTND), a standardized scale ranging from 0 to 10, with higher scores indicating a greater level of nicotine dependence.
number of cigarettes smoked
Time frame: from enrollment to the end of the treatment at 4 weeks
number of cigarettes smoked on each day
smoking cessation
Time frame: from enrollment to the end of the treatment at 4 weeks
smoking less than 5 cigarettes
2 secondary outcomes
mental well being score
Time frame: from enrollment to the end of the treatment at 4 weeks
HAPA stage
Time frame: from enrollment to the end of the treatment at 4 weeks
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 25 Apr 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.
duygu altin, phd principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POLSIS and routine service delivery(Nicotine Replacement Theraphy, Cytisine) in people with Smoking Cessation, run by Ege University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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 25 Apr 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 Turkey (Türkiye). 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?
the Fagerström Test for Nicotine Dependence (FTND) scores (time frame: from enrollment to the end of the treatment at 4 weeks). The study lists 3 primary outcomes in all. 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 25 Apr 2025.