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

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: POLSIS; Drug: routine service delivery(Nicotine Replacement Theraphy, Cytisine)

• Registration Number: NCT06945770
• Lead Sponsor: Ege University

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.

Study Timeline

• Study Start: 2024-05-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-20
• Last Update Submitted: 2025-04-20
• Study First Posted: 2025-04-25
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

• using internet
• being a volunteer

Exclusion Criteria

• not using internet
• not being a volunteer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POLSIS	POLSIS	web based smoking cessation psycho-education
POLSIS	routine service delivery(Nicotine Replacement Theraphy, Cytisine)	web based smoking cessation psycho-education
control	routine service delivery(Nicotine Replacement Theraphy, Cytisine)	routine service delivery

Primary Outcome Measures

Name	Time	Method
the Fagerström Test for Nicotine Dependence (FTND) scores	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	from enrollment to the end of the treatment at 4 weeks	number of cigarettes smoked on each day
smoking cessation	from enrollment to the end of the treatment at 4 weeks	smoking less than 5 cigarettes

Secondary Outcome Measures

Name	Time	Method
mental well being score	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.
HAPA stage	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.)

Trial Locations

Locations (1)

Ege University; 🇹🇷 Izmir, Turkey