Codependency, PsychologicalNCT05324644
The Effect of Motivational Interview Attempt on Self-Efficacy Level and Decision to Quit Smoking of University Students
A study testing Motivational interview in people with Codependency, Psychological, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effect of motivational interview initiatives on the smoking cessation decisions of university students. In this study, which will be conducted as a randomized, case-control study; Student introduction form, Fagerström Nicotine Addiction Test, Decision-Making Balance Scale… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Codependency, Psychological
- What is being tested?
- Motivational interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Students in Year 1
- Smoker,
- 18 years and older,
- Those who have not received a psychiatric diagnosis made by the physician,
- Those who want to quit smoking,
- Volunteer students who accept the motivational interview.
Who cannot join
- Non-smokers,
- 18 years old and under,
- Taking the course of the researcher teacher due to vulnerability,
- Students who do not want to participate voluntarily will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to determine the effect of motivational interview initiatives on the smoking cessation decisions of university students. In this study, which will be conducted as a randomized, case-control study; Student introduction form, Fagerström Nicotine Addiction Test, Decision-Making Balance Scale, Self-efficacy adequacy scale, Behavior Change Stage Diagnosis Short Questionnaire, Beck Depression Scale, Smoking Desire Scale will be used, CO will be measured. Motivational interview initiative will be applied to first-year students who are enrolled in the university, who smoke and are considering quitting. The estimated duration of the study is 8-10 months. Maximum number of volunteers will be 60.
Read the detailed description
More than 7 million people in the world and more than 100,000 people in Turkey die from diseases related to tobacco use annually. Young people are one of the most important target groups of the tobacco industry. For these reasons, one of the goals in the international and national (Tobacco Control Strategy Document and Action Plan 2018-2023 for Turkey) tobacco control programs is to include protective, preventive and therapeutic studies, especially for children and youth. Currently, there are two treatment approaches recommended for smoking cessation. They are pharmacological treatment and behavioural treatment/motivation. The aim of this study is to evaluate the effect of the motivational interview initiative on the self-efficacy level of university students and their decision to quit smoking.
The research will be conducted in a randomized, intervention-control group experimental research design. The study will be carried out on first-year students of a university. The universe of the research; 1st-year students (N: 4543) registered in the 2020-2021 academic year. The number of students to be reached after the announcement was determined as 358 by using the 72% value, which is the result of the smoking status determination survey conducted at the same university in the 2019-2020 academic year in the previous year, using the sample calculation method with the known universe.
The study will be announced on the website of the university where the research will be conducted for first-year students who smoke and want to quit. Students who want to participate, who have not been diagnosed with depression and whose Beck depression score is mild and minimally depressed will constitute the sample group.
The sample size was calculated using power analysis. Self-efficacy and efficacy score effect size between intervention and control was calculated as 0.49 and n=23 students from each group were calculated, with a 0.05 margin of error and Power of 83.83%. As a result of the sample number calculation, 23 intervention and 23 control group students should be included. Considering that there may be losses in the later stages of the study, 40 students will be included in the study for each group. In line with the feasibility of education and training during the pandemic process, face-to-face and online interviews will be held with the hybrid interview method. Students willing to quit smoking will be divided into control and intervention groups using the simple random sampling technique according to the random numbers assignment list created in the Excel program by the biostatistics expert. In order to avoid bias, students will not be informed about which group they are in by using the single-blind study technique.
Motivational interviews and related scales will be applied to the students in the initiative group and CO measurement will be made. In cases where it is not appropriate to measure CO due to pandemic conditions, students will not be able to measure it. Such cases will be recorded in the data collection form.
After the research, motivational interviews will be made to the students in the control group who want to support their decision to quit smoking.
The researcher who will conduct the interviews has received motivational interview technique training. For the individual motivational interview to be held with the students in the intervention group, the researcher will make the first interview by determining the appropriate times with the students. Afterwards, motivational interviews will be held at the 1st, 3rd and 6th months, in which relapses and behavioural changes are evaluated (Behavioral Change Stage Diagnosis Short Questionnaire). Interviews are planned to be conducted using a hybrid method (face-to-face or online).
In the first of the individual interviews with the students; It is planned to provide information about acquaintance and research, fill in the scales in 10-15 minutes, make and evaluate CO measurements, and also conduct an average of 20-40 minutes of motivational interviews in the intervention group. In the second interview in the 1st month, it is planned to summarize the first interview, fill in the scales in 3-5 minutes, make the CO measurements in 10-15 minutes or get the measurement results and apply a motivational interview in the average of 20-40 minutes. In the third interview in the 3rd month, it is planned to summarize the second interview in 3-5 min, fill in the scales in 10-15 minutes, make CO measurements or take the measurement results made by the students in the smoking cessation polyclinics and to apply motivational interviews for an average of 20-40 minutes. In the last interview in the 6th month, it is planned to summarize the 3rd-month interview, to apply the scales to both groups for approximately 10-15 minutes, to make CO measurements or to get the measurement results.
- Conditions
- Codependency, Psychological
- Being tested
- Motivational interview
- Keywords
- motivational interview, quit smoking, behavior change
- Medical subject headings
- Codependency, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewBehavioural
In the first interviews with the students; It is planned to provide information about acquaintance and research, fill in the scales in 10-15 minutes, make CO measurements, and also conduct an average of 20-40 minutes of motivational interviews in the intervention group. In the second interview in the 1st month, it is planned to summarize the first interview, fill in the scales in 3-5 minutes, make the CO measurements in 10-15 minutes or get the measurement results and apply motivational interview in the average of 20-40 minutes. In the third interview in the 3rd month, it is planned to summarize the second interview in 3-5 min, fill in the scales in 10-15 minutes, make CO measurements or get the measurement results and to apply motivational interviews for an average of 20-40 minutes. In the last interview in the 6th month, it is planned to summarize the 3rd-month interview, to apply the scales for approximately 10-15 minutes, to make CO measurements or to get the measurement results.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | 32 randomly selected first-year students in the university, who voluntarily agreed to be recruited into the study and smoke and are considering quitting. Receives: Behavioral: Motivational interview |
| Control group | No intervention | 32 randomly selected first-year students in the university, who voluntarily agreed to be recruited into the study and smoke and are considering quitting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of people who quit smoking
The number of people who quit smoking in the groups at the end of the study.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Apr 2021
- Primary completion30 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Codependency, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study is a randomized and case-control study.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Green Crescent (Yeşilay)
- Responsible party
- Principal investigator, Feyza Dereli, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324644
- Sponsor's protocol ID
- 1071
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akdur, R. Gençlerde Sigara Salgını (2010). Ankara Üniversitesi Tıp Fakültesi Halk Sağlığı Yayınları. Ankara
Apodaca TR, Abrantes AM, Strong DR, Ramsey SE, Brown RA. Readiness to change smoking behavior in adolescents with psychiatric disorders. Addict Behav. 2007 Jun;32(6):1119-30. doi: 10.1016/j.addbeh.2006.07.016. Epub 2006 Sep 1.
PubMed 16950572Demirezen M, Kurcer MA. Questionnaire of smoking urges Turkish validity and reliability. TAF Prev Med Bull 2016;15:1-4.
DiClemente CC, Prochaska JO, Fairhurst SK, Velicer WF, Velasquez MM, Rossi JS. The process of smoking cessation: an analysis of precontemplation, contemplation, and preparation stages of change. J Consult Clin Psychol. 1991 Apr;59(2):295-304. doi: 10.1037//0022-006x.59.2.295.
PubMed 2030191Doğan, DG,. Ulukol, B. (2010). Ergenlerin sigara içmesini etkileyen faktörler ve sigara karşıtı iki eğitim modelinin etkinliği. İnönü Üniversitesi Tıp Fakültesi Dergisi.79-85.
Edwards, L.K. (1993). Applied Analysis of Variance in the Behavior Sciences. Marcel Dekker. New York.
2008 PHS Guideline Update Panel, Liaisons, and Staff. Treating tobacco use and dependence: 2008 update U.S. Public Health Service Clinical Practice Guideline executive summary. Respir Care. 2008 Sep;53(9):1217-22. No abstract available.
PubMed 18807274Folkman S, Lazarus RS. An analysis of coping in a middle-aged community sample. J Health Soc Behav. 1980 Sep;21(3):219-39. No abstract available.
PubMed 7410799Gözüm S, Aksayan S. (1999). Öz-etkililik-yeterlik ölçeği'nin türkçe formunun güvenilirlik ve geçerliliği. Journal of Anatolia Nursing and Health Sciences;2(1):21-34.
Health New Zeland. (2009). Testing for Carbon Monoxide in exhaled breath. (2020). Erişim adresi: http://www.healthnz.co.nz/CObreath.htm.
Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
PubMed 1932883Hisli, N. (1989). Beck depresyon envanterinin üniversite öğrencileri için geçerliği, güvenirliği. Psikoloji Dergisi, 7(23), 3-13.
Kamışlı Özcan, S. (2007). Psikoeğitimsel Bir Programla Hemşirelerin Sigara Bırakma Durumları. Hacettepe Üniversitesi Sağlık Bilimleri Enstitüsü, Doktora Tezi. Ankara.
Karadağlı, F., Nahcivan, N. (2012). Sigara içen bireylerde sigara bırakmaya hazıroluşluk durumu ile ilişkili faktörler. DEUHYO Dergisi, 5(1), (s. 8- 15).
Karagöz Y. SPSS 21.1 (2014). Uygulamalı Biyoistatistik. İstanbul: Nobel Tıp Kitabevi; .s.1-740.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interview Attempt on Self-Efficacy Level and Decision to Quit Smoking of University Students
- ClinicalTrials.gov ID
- NCT05324644
- Acronym / sponsor ID
- 1071
- Conditions
- Codependency, Psychological
- Keywords
- motivational interview, quit smoking, behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Green Crescent (Yeşilay)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to determine the effect of motivational interview initiatives on the smoking cessation decisions of university students. In this study, which will be conducted as a randomized, case-control study; Student introduction form, Fagerström Nicotine Addiction Test, Decision-Making Balance Scale, Self-efficacy adequacy scale, Behavior Change Stage Diagnosis Short Questionnaire, Beck Depression Scale, Smoking Desire Scale will be used, CO will be measured. Motivational interview initiative will be applied to first-year students who are enrolled in the university, who smoke and are considering quitting. The estimated duration of the study is 8-10 months. Maximum number of volunteers will be 60.
Detailed description
More than 7 million people in the world and more than 100,000 people in Turkey die from diseases related to tobacco use annually. Young people are one of the most important target groups of the tobacco industry. For these reasons, one of the goals in the international and national (Tobacco Control Strategy Document and Action Plan 2018-2023 for Turkey) tobacco control programs is to include protective, preventive and therapeutic studies, especially for children and youth. Currently, there are two treatment approaches recommended for smoking cessation. They are pharmacological treatment and behavioural treatment/motivation. The aim of this study is to evaluate the effect of the motivational interview initiative on the self-efficacy level of university students and their decision to quit smoking.
The research will be conducted in a randomized, intervention-control group experimental research design. The study will be carried out on first-year students of a university. The universe of the research; 1st-year students (N: 4543) registered in the 2020-2021 academic year. The number of students to be reached after the announcement was determined as 358 by using the 72% value, which is the result of the smoking status determination survey conducted at the same university in the 2019-2020 academic year in the previous year, using the sample calculation method with the known universe.
The study will be announced on the website of the university where the research will be conducted for first-year students who smoke and want to quit. Students who want to participate, who have not been diagnosed with depression and whose Beck depression score is mild and minimally depressed will constitute the sample group.
The sample size was calculated using power analysis. Self-efficacy and efficacy score effect size between intervention and control was calculated as 0.49 and n=23 students from each group were calculated, with a 0.05 margin of error and Power of 83.83%. As a result of the sample number calculation, 23 intervention and 23 control group students should be included. Considering that there may be losses in the later stages of the study, 40 students will be included in the study for each group. In line with the feasibility of education and training during the pandemic process, face-to-face and online interviews will be held with the hybrid interview method. Students willing to quit smoking will be divided into control and intervention groups using the simple random sampling technique according to the random numbers assignment list created in the Excel program by the biostatistics expert. In order to avoid bias, students will not be informed about which group they are in by using the single-blind study technique.
Motivational interviews and related scales will be applied to the students in the initiative group and CO measurement will be made. In cases where it is not appropriate to measure CO due to pandemic conditions, students will not be able to measure it. Such cases will be recorded in the data collection form.
After the research, motivational interviews will be made to the students in the control group who want to support their decision to quit smoking.
The researcher who will conduct the interviews has received motivational interview technique training. For the individual motivational interview to be held with the students in the intervention group, the researcher will make the first interview by determining the appropriate times with the students. Afterwards, motivational interviews will be held at the 1st, 3rd and 6th months, in which relapses and behavioural changes are evaluated (Behavioral Change Stage Diagnosis Short Questionnaire). Interviews are planned to be conducted using a hybrid method (face-to-face or online).
In the first of the individual interviews with the students; It is planned to provide information about acquaintance and research, fill in the scales in 10-15 minutes, make and evaluate CO measurements, and also conduct an average of 20-40 minutes of motivational interviews in the intervention group. In the second interview in the 1st month, it is planned to summarize the first interview, fill in the scales in 3-5 minutes, make the CO measurements in 10-15 minutes or get the measurement results and apply a motivational interview in the average of 20-40 minutes. In the third interview in the 3rd month, it is planned to summarize the second interview in 3-5 min, fill in the scales in 10-15 minutes, make CO measurements or take the measurement results made by the students in the smoking cessation polyclinics and to apply motivational interviews for an average of 20-40 minutes. In the last interview in the 6th month, it is planned to summarize the 3rd-month interview, to apply the scales to both groups for approximately 10-15 minutes, to make CO measurements or to get the measurement results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a randomized and case-control study.
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Behavioral: Motivational interview32 randomly selected first-year students in the university, who voluntarily agreed to be recruited into the study and smoke and are considering quitting. |
| Control group | No intervention | –32 randomly selected first-year students in the university, who voluntarily agreed to be recruited into the study and smoke and are considering quitting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Students in Year 1
- Smoker,
- 18 years and older,
- Those who have not received a psychiatric diagnosis made by the physician,
- Those who want to quit smoking,
Key exclusion criteria (4 listed)
- Non-smokers,
- 18 years old and under,
- Taking the course of the researcher teacher due to vulnerability,
- Students who do not want to participate voluntarily will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewIn the first interviews with the students; It is planned to provide information about acquaintance and research, fill in the scales in 10-15 minutes, make CO measurements, and also conduct an average of 20-40 minutes of motivational interviews in the intervention group. In the second interview in the 1st month, it is planned to summarize the first interview, fill in the scales in 3-5 minutes, make the CO measurements in 10-15 minutes or get the measurement results and apply motivational interview in the average of 20-40 minutes. In the third interview in the 3rd month, it is planned to summarize the second interview in 3-5 min, fill in the scales in 10-15 minutes, make CO measurements or get the measurement results and to apply motivational interviews for an average of 20-40 minutes. In the last interview in the 6th month, it is planned to summarize the 3rd-month interview, to apply the scales for approximately 10-15 minutes, to make CO measurements or to get the measurement results. | Behavioural | Interventional group |
Primary outcome
Number of people who quit smoking
Time frame: Six months
The number of people who quit smoking in the groups at the end of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- BackgroundAkdur, R. Gençlerde Sigara Salgını (2010). Ankara Üniversitesi Tıp Fakültesi Halk Sağlığı Yayınları. Ankara
- Background: PubMed 16950572Apodaca TR, Abrantes AM, Strong DR, Ramsey SE, Brown RA. Readiness to change smoking behavior in adolescents with psychiatric disorders. Addict Behav. 2007 Jun;32(6):1119-30. doi: 10.1016/j.addbeh.2006.07.016. Epub 2006 Sep 1.
- BackgroundDemirezen M, Kurcer MA. Questionnaire of smoking urges Turkish validity and reliability. TAF Prev Med Bull 2016;15:1-4.
- Background: PubMed 2030191DiClemente CC, Prochaska JO, Fairhurst SK, Velicer WF, Velasquez MM, Rossi JS. The process of smoking cessation: an analysis of precontemplation, contemplation, and preparation stages of change. J Consult Clin Psychol. 1991 Apr;59(2):295-304. doi: 10.1037//0022-006x.59.2.295.
- BackgroundDoğan, DG,. Ulukol, B. (2010). Ergenlerin sigara içmesini etkileyen faktörler ve sigara karşıtı iki eğitim modelinin etkinliği. İnönü Üniversitesi Tıp Fakültesi Dergisi.79-85.
- BackgroundEdwards, L.K. (1993). Applied Analysis of Variance in the Behavior Sciences. Marcel Dekker. New York.
- Background: PubMed 188072742008 PHS Guideline Update Panel, Liaisons, and Staff. Treating tobacco use and dependence: 2008 update U.S. Public Health Service Clinical Practice Guideline executive summary. Respir Care. 2008 Sep;53(9):1217-22. No abstract available.
- Background: PubMed 7410799Folkman S, Lazarus RS. An analysis of coping in a middle-aged community sample. J Health Soc Behav. 1980 Sep;21(3):219-39. No abstract available.
- BackgroundGözüm S, Aksayan S. (1999). Öz-etkililik-yeterlik ölçeği'nin türkçe formunun güvenilirlik ve geçerliliği. Journal of Anatolia Nursing and Health Sciences;2(1):21-34.
- BackgroundHealth New Zeland. (2009). Testing for Carbon Monoxide in exhaled breath. (2020). Erişim adresi: http://www.healthnz.co.nz/CObreath.htm.
- Background: PubMed 1932883Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
- BackgroundHisli, N. (1989). Beck depresyon envanterinin üniversite öğrencileri için geçerliği, güvenirliği. Psikoloji Dergisi, 7(23), 3-13.
- Green crescentLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interview in people with Codependency, Psychological, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of people who quit smoking (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05324644, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.