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

NCT ID: NCT06945770

Last Updated: 2025-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-01-01

Brief Summary

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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

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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

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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POLSIS

web based smoking cessation psycho-education

Group Type EXPERIMENTAL

POLSIS

Intervention Type BEHAVIORAL

web based smoking cessation psycho-education

routine service delivery(Nicotine Replacement Theraphy, Cytisine)

Intervention Type DRUG

routine smoking cessation service delivery

control

routine service delivery

Group Type ACTIVE_COMPARATOR

routine service delivery(Nicotine Replacement Theraphy, Cytisine)

Intervention Type DRUG

routine smoking cessation service delivery

Interventions

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POLSIS

web based smoking cessation psycho-education

Intervention Type BEHAVIORAL

routine service delivery(Nicotine Replacement Theraphy, Cytisine)

routine smoking cessation service delivery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* using internet
* being a volunteer

Exclusion Criteria

* not using internet
* not being a volunteer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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duygu altin

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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duygu altin, phd

Role: PRINCIPAL_INVESTIGATOR

Ege University

Locations

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Ege University

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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29724

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

23-4.1T/26

Identifier Type: -

Identifier Source: org_study_id

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