- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06443294
Development of a Smoking Cessation Video Series
May 29, 2024 updated by: Michael Schmidt, Wayne State University
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Recruiting
- Wayne State University
-
Contact:
- Michael BR Schmidt, MA
- Phone Number: 734-780-4110
- Email: schmidtmbr@wayne.edu
-
Contact:
- Emily Grekin, PhD
- Phone Number: 313-577-2820
- Email: grekine@wayne.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Daily smoker
- Interested in reducing smoking
- Not currently enrolled in any smoking cessation program.
Exclusion Criteria:
- Not interested in reducing smoking
- Currently enrolled in a smoking cessation program.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Video Group
Participants randomly assigned to this group will be provided access to the video intervention 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.
|
No Intervention: No-Video Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking Quantity/Frequency
Time Frame: Measured at baseline and 30 days following completion of video series.
|
Cigarettes smoked in past 30 days.
|
Measured at baseline and 30 days following completion of video series.
|
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.).
|
Measured upon completion of video series, within 2 weeks of beginning study.
|
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)
|
Measured upon completion of video series (within 2 weeks of beginning study) and at 30-day follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Working Alliance Inventory for Guided Internet Interventions
Time Frame: Measured upon completion of video series, within 2 weeks of beginning study.
|
Participants' sense of alliance with therapist leading video intervention.
(WAI-I: Penedo et al., 2020).
|
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.
|
Participants' level of motivation to change smoking behavior measured using a stages of change ladder based in Motivational Interviewing principles.
|
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.
|
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 at 30-day follow-up.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Magill 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.
- Lee 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.
- 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.
- Burman 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.
- Grant 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.
- Guo 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.
- Richardson 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 25, 2024
Primary Completion (Estimated)
October 1, 2024
Study Completion (Estimated)
October 1, 2024
Study Registration Dates
First Submitted
April 25, 2024
First Submitted That Met QC Criteria
May 29, 2024
First Posted (Actual)
June 5, 2024
Study Record Updates
Last Update Posted (Actual)
June 5, 2024
Last Update Submitted That Met QC Criteria
May 29, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- IRB-23-10-6207
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data is not planned to be shared with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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