Tobacco Use CessationNCT06443294
Development of a Smoking Cessation Video Series
A study testing Smoking cessation video series. in people with Tobacco Use Cessation and Tobacco Smoking, run by Wayne State University at 1 site in United States.
Trial summary
This study seeks to develop and test an internet video series aimed at helping individuals reduce cigarette smoking. Participants (daily smokers) will be asked to watch a series of six videos (approximately 6.5 minutes each) which cover various empirically-supported smoking cessation strategies and tools. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Cessation, Tobacco Smoking
- What is being tested?
- Smoking cessation video series.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2024to 1 Oct 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Daily smoker
- Interested in reducing smoking
- Not currently enrolled in any smoking cessation program.
Who cannot join
- Not interested in reducing smoking
- Currently enrolled in a smoking cessation program.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Wayne State University
Detroit, Michigan, 48202
Michael BR Schmidt, MA, 734-780-4110, schmidtmbr@wayne.edu
Emily Grekin, PhD, 313-577-2820, grekine@wayne.edu
About this study
This study seeks to develop and test an internet video series aimed at helping individuals reduce cigarette smoking. Participants (daily smokers) will be asked to watch a series of six videos (approximately 6.5 minutes each) which cover various empirically-supported smoking cessation strategies and tools. Examples of strategies included in the videos include noticing smoking cues and consequences and relaxation training. Participants' demographic information, motivation to change, reactions to the video series alliance with video therapist, and confidence in avoiding smoking will all be measured. Additionally, participants will be asked to report their smoking behavior at study baseline and follow-up.
- Conditions
- Tobacco Use Cessation, Tobacco Smoking
- Being tested
- Smoking cessation video series.
- Medical subject headings
- Tobacco Use Cessation, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation video series.Behavioural
The intervention in this study is a series of six videos totally approximately 40 minutes. These videos are led by a doctoral psychology student with experience in working with tobacco smokers. Videos utilize empirically-supported strategies for smoking cessation.
| Study group | Role | What they receive |
|---|---|---|
| Video Group | Experimental | Participants randomly assigned to this group will be provided access to the video intervention series. Receives: Behavioral: Smoking cessation video series. |
| No-Video Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Quantity/Frequency
Cigarettes smoked in past 30 days.
Measured: Measured at baseline and 30 days following completion of video series.
Subjective Reactions to Video Series
Scale based on measure previously developed and used by PI of this study (Schmidt et al., 2023). Outcome explores participants' experience with and opinions of video intervention (e.g., video helpfulness, clarity, etc.).
Measured: Measured upon completion of video series, within 2 weeks of beginning study.
Self-Efficacy Questionnaire
Participants' belief in their ability to avoid smoking. SEQ-12: Etter et al., 2000)
Measured: Measured upon completion of video series (within 2 weeks of beginning study) and at 30-day follow-up.
Secondary outcomes (3)
The Working Alliance Inventory for Guided Internet Interventions
Participants' sense of alliance with therapist leading video intervention. (WAI-I: Penedo et al., 2020).
Measured: Measured upon completion of video series, within 2 weeks of beginning study.
Motivation to Quit Smoking (Change Ladder)
Participants' level of motivation to change smoking behavior measured using a stages of change ladder based in Motivational Interviewing principles.
Measured: Measured upon completion of video series (within 2 weeks of beginning study) and one-month follow-up.
Smoking Quit Attempt
Whether participants made a quit attempt during the course of the study. Measured using a single, "yes or no" item asking whether participants attempted to quit smoking in the past month.
Measured: Measured at 30-day follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start25 Apr 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Schmidt, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443294
- Sponsor's protocol ID
- IRB-23-10-6207
- Status last verified
- May 2024
- First submitted
- 25 Apr 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data is not planned to be shared with other researchers.
Publications
Abroms LC, Lee Westmaas J, Bontemps-Jones J, Ramani R, Mellerson J. A content analysis of popular smartphone apps for smoking cessation. Am J Prev Med. 2013 Dec;45(6):732-6. doi: 10.1016/j.amepre.2013.07.008.
PubMed 24237915Burman A, Haeder SF, Xu WY. Provider directory inaccuracy and timely access for mental health care. Am J Manag Care. 2023 Feb;29(2):96-102. doi: 10.37765/ajmc.2023.89318.
PubMed 36811984Grant S, Colaiaco B, Motala A, Shanman R, Booth M, Sorbero M, Hempel S. Mindfulness-based Relapse Prevention for Substance Use Disorders: A Systematic Review and Meta-analysis. J Addict Med. 2017 Sep/Oct;11(5):386-396. doi: 10.1097/ADM.0000000000000338.
PubMed 28727663Guo YQ, Chen Y, Dabbs AD, Wu Y. The Effectiveness of Smartphone App-Based Interventions for Assisting Smoking Cessation: Systematic Review and Meta-analysis. J Med Internet Res. 2023 Apr 20;25:e43242. doi: 10.2196/43242.
PubMed 37079352Lee EB, An W, Levin ME, Twohig MP. An initial meta-analysis of Acceptance and Commitment Therapy for treating substance use disorders. Drug Alcohol Depend. 2015 Oct 1;155:1-7. doi: 10.1016/j.drugalcdep.2015.08.004. Epub 2015 Aug 13.
PubMed 26298552Magill M, Ray L, Kiluk B, Hoadley A, Bernstein M, Tonigan JS, Carroll K. A meta-analysis of cognitive-behavioral therapy for alcohol or other drug use disorders: Treatment efficacy by contrast condition. J Consult Clin Psychol. 2019 Dec;87(12):1093-1105. doi: 10.1037/ccp0000447. Epub 2019 Oct 10.
PubMed 31599606Richardson CG, Vettese L, Sussman S, Small SP, Selby P. An investigation of smoking cessation video content on YouTube. Subst Use Misuse. 2011;46(7):893-7. doi: 10.3109/10826084.2011.570628.
PubMed 21599505
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Smoking Cessation Video Series
- ClinicalTrials.gov ID
- NCT06443294
- Acronym / sponsor ID
- IRB-23-10-6207
- Conditions
- Tobacco Use Cessation, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 5 Jun 2024 (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 seeks to develop and test an internet video series aimed at helping individuals reduce cigarette smoking. Participants (daily smokers) will be asked to watch a series of six videos (approximately 6.5 minutes each) which cover various empirically-supported smoking cessation strategies and tools. Examples of strategies included in the videos include noticing smoking cues and consequences and relaxation training. Participants' demographic information, motivation to change, reactions to the video series alliance with video therapist, and confidence in avoiding smoking will all be measured. Additionally, participants will be asked to report their smoking behavior at study baseline and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Group | Experimental | Behavioral: Smoking cessation video series.Participants randomly assigned to this group will be provided access to the video intervention series. |
| No-Video Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Daily smoker
- Interested in reducing smoking
- Not currently enrolled in any smoking cessation program.
Key exclusion criteria (2 listed)
- Not interested in reducing smoking
- Currently enrolled in a smoking cessation program.
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 |
|---|---|---|
| Smoking cessation video series.The intervention in this study is a series of six videos totally approximately 40 minutes. These videos are led by a doctoral psychology student with experience in working with tobacco smokers. Videos utilize empirically-supported strategies for smoking cessation. | Behavioural | Video Group |
Primary outcome
Smoking Quantity/Frequency
Time frame: Measured at baseline and 30 days following completion of video series.
Cigarettes smoked in past 30 days.
Subjective Reactions to Video Series
Time frame: Measured upon completion of video series, within 2 weeks of beginning study.
Scale based on measure previously developed and used by PI of this study (Schmidt et al., 2023). Outcome explores participants' experience with and opinions of video intervention (e.g., video helpfulness, clarity, etc.).
Self-Efficacy Questionnaire
Time frame: Measured upon completion of video series (within 2 weeks of beginning study) and at 30-day follow-up.
Participants' belief in their ability to avoid smoking. SEQ-12: Etter et al., 2000)
3 secondary outcomes
The Working Alliance Inventory for Guided Internet Interventions
Time frame: Measured upon completion of video series, within 2 weeks of beginning study.
Motivation to Quit Smoking (Change Ladder)
Time frame: Measured upon completion of video series (within 2 weeks of beginning study) and one-month follow-up.
Smoking Quit Attempt
Time frame: Measured at 30-day follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Background: PubMed 24237915Abroms LC, Lee Westmaas J, Bontemps-Jones J, Ramani R, Mellerson J. A content analysis of popular smartphone apps for smoking cessation. Am J Prev Med. 2013 Dec;45(6):732-6. doi: 10.1016/j.amepre.2013.07.008.
- Background: PubMed 36811984Burman A, Haeder SF, Xu WY. Provider directory inaccuracy and timely access for mental health care. Am J Manag Care. 2023 Feb;29(2):96-102. doi: 10.37765/ajmc.2023.89318.
- Background: PubMed 28727663Grant S, Colaiaco B, Motala A, Shanman R, Booth M, Sorbero M, Hempel S. Mindfulness-based Relapse Prevention for Substance Use Disorders: A Systematic Review and Meta-analysis. J Addict Med. 2017 Sep/Oct;11(5):386-396. doi: 10.1097/ADM.0000000000000338.
- Background: PubMed 37079352Guo YQ, Chen Y, Dabbs AD, Wu Y. The Effectiveness of Smartphone App-Based Interventions for Assisting Smoking Cessation: Systematic Review and Meta-analysis. J Med Internet Res. 2023 Apr 20;25:e43242. doi: 10.2196/43242.
- Background: PubMed 26298552Lee EB, An W, Levin ME, Twohig MP. An initial meta-analysis of Acceptance and Commitment Therapy for treating substance use disorders. Drug Alcohol Depend. 2015 Oct 1;155:1-7. doi: 10.1016/j.drugalcdep.2015.08.004. Epub 2015 Aug 13.
- Background: PubMed 31599606Magill M, Ray L, Kiluk B, Hoadley A, Bernstein M, Tonigan JS, Carroll K. A meta-analysis of cognitive-behavioral therapy for alcohol or other drug use disorders: Treatment efficacy by contrast condition. J Consult Clin Psychol. 2019 Dec;87(12):1093-1105. doi: 10.1037/ccp0000447. Epub 2019 Oct 10.
- Background: PubMed 21599505Richardson CG, Vettese L, Sussman S, Small SP, Selby P. An investigation of smoking cessation video content on YouTube. Subst Use Misuse. 2011;46(7):893-7. doi: 10.3109/10826084.2011.570628.
- Individual participant dataSharing planned: No. Individual participant data is not planned to be shared with other researchers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation video series. in people with Tobacco Use Cessation and Tobacco Smoking, run by Wayne State University at 1 site in United States.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Jun 2024. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Quantity/Frequency (time frame: Measured at baseline and 30 days following completion of video series.). The study lists 3 primary outcomes in all. 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 NCT06443294, which also lists 7 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 5 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.