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Web-based Smoking Intervention as an add-on to Routine Smoking Cessation Clinical Treatment

Web-based Smoking Intervention as an add-on to Routine Smoking Cessation Clinical Treatment: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06945770
Acronym
POLSIS
Enrollment
208
Registered
2025-04-25
Start date
2024-05-01
Completion date
2025-01-01
Last updated
2025-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

tobacco use disorder, smoking cessation, web-based psycho-education

Brief 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. 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.

Interventions

BEHAVIORALPOLSIS

web based smoking cessation psycho-education

DRUGroutine service delivery(Nicotine Replacement Theraphy, Cytisine)

routine smoking cessation service delivery

Sponsors

Ege University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* using internet * being a volunteer

Exclusion criteria

* not using internet * not being a volunteer

Design outcomes

Primary

MeasureTime frameDescription
the Fagerström Test for Nicotine Dependence (FTND) scoresfrom enrollment to the end of the treatment at 4 weeksNicotine 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 smokedfrom enrollment to the end of the treatment at 4 weeksnumber of cigarettes smoked on each day
smoking cessationfrom enrollment to the end of the treatment at 4 weekssmoking less than 5 cigarettes

Secondary

MeasureTime frameDescription
mental well being scorefrom enrollment to the end of the treatment at 4 weeksThe 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.
HAPA stagefrom enrollment to the end of the treatment at 4 weeksHAPA 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.)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026