Effectiveness of Smoking Cessation Education

NCT06930547 | Recruiting

• 1 other identifier: 151605122024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Smoking is an important psychosocial problem that concerns society. It is reported that 1.3 billion people use tobacco products in the world and approximately 6 million people lose their lives due to smoking every year. Despite the high mortality rate, smoking addiction is shown as one of the biggest preventable diseases and causes of death. Individuals with mental health problems have a much higher smoking rate than the general population. Studies show that people with severe mental disorders such as schizophrenia, bipolar disorder and major depression have a smoking rate three to four times higher than the general population. It has been reported that this high smoking rate is associated with more morbidity, mortality and increased healthcare costs in individuals with severe mental disorders. It is reported that nurses, who spend the most time with patients and constitute the largest group of healthcare personnel, have an effective role in smoking cessation initiatives. The importance of nurses in tobacco control is emphasized in the publication titled "Nurses for a Tobacco-Free Life" by the International Council of Nursing (ICN). Although both national and international literature demonstrates that smoking is a serious problem in individuals with severe mental illness through descriptive research results, it is seen that smoking cessation intervention studies are quite limited. Randomized controlled intervention studies examining the effectiveness of smoking cessation interventions applied by nurses to individuals with severe mental illnesses could not be found in the literature. This study will be conducted to examine the effectiveness of smoking cessation education in patients registered in a community mental health center. In light of this information, this study was planned as a randomized controlled study to examine the effectiveness of smoking cessation education in patients registered in a community mental health center. The data obtained from this study will reveal the effectiveness of smoking cessation education in individuals with severe mental illnesses and contribute to filling the gap in the literature in this area. In addition, a method for using smoking cessation education in individuals with severe mental illnesses will be presented with a high level of evidence study.

Conditions

Tobacco Use Disorder; Mental Disorders; Smoking Cessation

Keywords

Tobacco Use Disorder; Mental Disorders; Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• Fagerström Test for Nicotine Dependence (FTND):

  Developed in 1991 by Heatherton and colleagues (Heatherton et al., 1991), the FTND is a self-assessment scale used to evaluate individuals' risk of physical nicotine dependence, measure the level and intensity of addiction. It includes binary and four-point Likert-type questions, ranging between 0-1 and 0-3. The test consists of six questions, and the total score can range from 0 to 10 points. Based on the score, individuals are categorized as follows: 0-2 points: "Very low dependence" 3-4 points: "Low dependence" 5 points: "Moderate dependence" 6-7 points: "High dependence" 8-10 points: "Very high dependence" (Uysal et al., 2004; Güneş Ersoy, 2019).

  Pre-test before the training, Post-test immediately after the training, 1st follow-up 1 month after the training, 2nd follow-up 3 months after the 1st follow-up

• Self-Efficacy Scale

  According to Karancı, the Self-Efficacy Scale (SES) was developed in 1984 by Nicki and colleagues. Based on social learning theories, the concept relates to an individual's belief in their ability to perform a desired behavior. Strengthening this belief is frequently used in smoking cessation efforts. The validity and reliability studies of the Self-Efficacy Scale were conducted by Karancı (1992). The scale consists of 25 items, and each item is rated on a 1-5 scale, with the options ranging from "Not sure at all: 1" to "Absolutely sure: 5". The total score ranges from 25 to 125. A higher score reflects a stronger belief in the ability to quit smoking. As the score increases, so does the belief in one's ability to quit smoking (Karancı, 1992).

  Pre-test before the training, Post-test immediately after the training, 1st follow-up 1 month after the training, 2nd follow-up 3 months after the 1st follow-up

Study Arms (2)

control group

NO INTERVENTION

This group will not receive the smoking cessation training.

İntervention

EXPERIMENTAL

Smoking cessation training will be applied to this group

Other: Experimental

Interventions

Experimental OTHER

In this study, the experimental group will undergo a smoking cessation training program consisting of eight sessions over four weeks, conducted twice a week. Each session is planned to last approximately 40-45 minutes. During the program, before each session, the previous session will be reviewed to reinforce learning and establish continuity between sessions. Feedback will be collected to ensure engagement and comprehension. At the end of each session, a summary of the session's agenda will be provided. Before each session, both the experimental and control groups will be evaluated using a smoking cessation status form to assess their progress. Additionally, follow-up assessments will be conducted one month and three months after the program to test the retention of the training's effectiveness.

İntervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being registered with TRSM (Community Mental Health Center)
• Being in the remission phase (the period after the patient's treatment is completed, with no observed active symptoms and improved insight)
• Smoking at least one cigarette per day regularly
• Being open to communication and collaboration
• Being over the age of 18
• Volunteering to participate in the study.

You may not qualify if:

• Not being registered with TRSM (Community Mental Health Center)
• Not being in the remission phase (presence of active symptoms or lack of improved insight)
• Smoking less than one cigarette per day
• Being unwilling or unable to communicate and collaborate effectively
• Being under the age of 18
• Not volunteering or unwilling to participate in the study.

Sponsors & Collaborators

• Erzurum Technical University: lead

Study Sites (1)

Erzurum Community Mental Health Center

Erzurum, Erzurum, 25050, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder; Mental Disorders; Smoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Health Behavior; Behavior

Study Officials

• Zeynep ÖZTÜRK, PHD

  Erzurum Technical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeynep ÖZTÜRK, PHD

CONTACT

90539-796-88-99; zeynepolcun6@gmail.com

Ayşe METİN, PHD

CONTACT

0506-681-23-98

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental group Control group

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: December 5, 2024
• Primary Completion: May 5, 2025
• Study Completion: August 15, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)