Clinical trial NCT06945770: Web-based Smoking Intervention as an add-on to Routine Smoking Cessation Clinical Treatment
Official title: Web-based Smoking Intervention as an add-on to Routine Smoking Cessation Clinical Treatment: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: tobacco use disorder
smoking cessation
web-based psycho-education
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* using internet
* being a volunteer

Exclusion Criteria:

* not using internet
* not being a volunteer

Primary outcomes:
measure: the Fagerström Test for Nicotine Dependence (FTND) scores
timeFrame: from enrollment to the end of the treatment at 4 weeks
measure: number of cigarettes smoked
timeFrame: from enrollment to the end of the treatment at 4 weeks
measure: smoking cessation
timeFrame: from enrollment to the end of the treatment at 4 weeks
Secondary outcomes:
measure: mental well being score
timeFrame: from enrollment to the end of the treatment at 4 weeks
measure: HAPA stage
timeFrame: from enrollment to the end of the treatment at 4 weeks
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University
Study officials:
affiliation: Ege University
name: duygu altin, phd
role: PRINCIPAL_INVESTIGATOR
References: