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

April 20, 2025 updated by: duygu altin, Ege University

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:

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Izmir, Turkey
        • Ege University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • using internet
  • being a volunteer

Exclusion Criteria:

  • not using internet
  • not being a volunteer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: POLSIS
web based smoking cessation psycho-education
Behavioral: POLSIS
web based smoking cessation psycho-education
Drug: routine service delivery(Nicotine Replacement Theraphy, Cytisine)
routine smoking cessation service delivery
Active Comparator: control
routine service delivery
Drug: routine service delivery(Nicotine Replacement Theraphy, Cytisine)
routine smoking cessation service delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from enrollment to the end of the treatment at 4 weeks
number of cigarettes smoked
Time Frame: from enrollment to the end of the treatment at 4 weeks
number of cigarettes smoked on each day
from enrollment to the end of the treatment at 4 weeks
smoking cessation
Time Frame: from enrollment to the end of the treatment at 4 weeks
smoking less than 5 cigarettes
from enrollment to the end of the treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mental well being score
Time Frame: from enrollment to the end of the treatment at 4 weeks
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.
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

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.)
from enrollment to the end of the treatment at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Principal Investigator: duygu altin, phd, Ege University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

April 11, 2025

First Submitted That Met QC Criteria

April 20, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 20, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-4.1T/26
  • 29724 (Other Grant/Funding Number: EGE UNIVERSITY Office of Scientific Research Projects)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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