Henry M Goldman School of Dental Medicine
Boston, Massachusetts, 02118, United States
NCT Number: NCT04524533
The goal of this randomized controlled trial (RCT) is to test whether a smoking cessation induction intervention delivered during a dental cleaning appointment increases the utilization of evidence-based treatments (EBTs) for smoking cessation within 7 months post-dental cleaning appointment.
Approximately 400 cigarette smokers who are scheduled for a dental cleaning appointment at the Boston University Goldman School of Dental Medicine (BUGSDM) patient treatment center will be recruited and enrolled. Participants will be randomized to either the intervention or control group
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02118, United States
Approximately 400 patients who have a scheduled prophylaxis, root planing and scaling dental appointment at the BUGSDM patient treatment center will be recruited and enrolled in the randomized controlled trial. Participants who complete the baseline survey will be randomized to either the intervention or control group. The intervention group will watch one of two smoking cessation videos during the appointment (depending on readiness to quit), receive a brochure about EBTs for smoking cessation, and participate in a 4-week tailored text message program designed to motivate EBT utilization. After the 4-week text message program, the intervention group will receive monthly assessment text messages for six months. The control group will watch a control video during the appointment, receive the same brochure about EBTs as the intervention group, and participate in an assessment-only 4-week text message program. All videos are approximately 10 minutes long.
After the dental clinic appointment, all participants will complete an online questionnaire and begin the 4-week text message program.
At the end of the 4-week text message program, and 3 and 6 months later, all participants will complete online questionnaires.
Primary Aim 1: To test the efficacy of the intervention vs. control in increasing utilization of EBTs over the course of follow-up (7-months). Hypothesis 1.1: Smokers randomized to the intervention will be more likely to engage with (contact) EBTs. Hypothesis 1.2: Smokers randomized to the intervention will have greater treatment utilization (e.g., more days in the text message program, more days using smoking cessation medication, and more quitline counseling sessions, greater number of EBTs).
Secondary Aims:
Aim 2: To test the effect of the intervention vs. controls on quit attempts and on motivation to quit. Hypothesis 2: Smokers randomized to the intervention will have more quit attempts and higher motivation to quit.
Aim 3: To test the efficacy of the intervention vs controls on biochemically verified abstinence. Hypothesis 3: Smokers randomized to the intervention will have higher quit rates at follow-up.
Aim 4: To assess the mechanisms through which the intervention effects occur (social cognitive mediators) and to identify subpopulations for whom intervention effects differ (moderators, e.g., readiness to quit, gender, race/ethnicity). Hypothesis 4: The intervention will directly affect the putative mediators, which will in turn affect EBT utilization. The role of moderators will be exploratory.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants who are randomized to the intervention group will watch an educational video that includes tips on quitting smoking during a dental cleaning. The video is approximately 10 minutes long and tailored to readiness to quit at the time of the dental visit.
Participants randomized to the control group will watch a 10 minute video.
All participants will receive identical print materials on EBTs consistent with smoking cessation standard clinical care.
Participants randomized to the intervention group will be enrolled in a 4-week tailored text message program which includes assessment questions in addition to text messages geared towards motivating and facilitating EBT utilization for individuals ready to quit smoking and individuals who are not ready to quit smoking.
Participants randomized to the control group will be enrolled in a different 4-week text message program that includes only assessment questions.
Time frame: 7 months
Self-reported use of any Evidence-Based Treatment (EBT) for smoking cessation. Participants indicated whether they used any EBT during the study. EBT is defined according to clinical practice guidelines and include: counseling (individual or group counseling at a clinic or community center and telehealth), a telephone quit line (Massachusetts quitline), quit smoking text-message programs (National Cancer Institute's "SmokefreeTXT" or Massachusetts quitline text program), Nicotine Replacement Therapy (patch, gum, lozenge, inhaler), and non-nicotine quit smoking medications (bupropion or varenicline).
Time frame: 7 months
Objectively verified use of the following EBT: the text message program SmokefreeTXT and/or the Massachusetts state quitline. Verification of use will occur through review of usage databases from the vendors.
Time frame: 7 months
Self-reported use of combination EBT defined according to clinical guidelines as use of a pharmacologic product (NRT or non-nicotine medications) combined with behavioral support (counseling, quitline, or text-message program).
Time frame: 7 months
Self-reported use of the total number of EBT computed by counting the different type of EBTs used for smoking cessation in any combination (range 0 - 4).
Time frame: 7 months
TM and questionnaire assessment of self-reported use of any Evidence-Based Treatment (EBT) for smoking cessation. Participants indicated whether they used any EBT during the study (for the intervention group, responses were also obtained through text message assessments during the course of the study). EBT is defined according to clinical practice guidelines and include: counseling (individual or group counseling at a clinic or community center and telehealth), a telephone quit line (Massachusetts quitline), quit smoking text-message programs (National Cancer Institute's "SmokefreeTXT" or Massachusetts quitline text program), Nicotine Replacement Therapy (patch, gum, lozenge, inhaler), and non-nicotine quit smoking medications (bupropion or varenicline).
Time frame: 7 months
Participants self-report of no smoking, not even a puff, in the preceding 7 days.
Time frame: 7 months
Participants self-report of no smoking, not even a puff, in the preceding 7 days will be biochemically confirmed through salivary cotinine analysis using the clinically recommended cut off level (<15 ng/mL = verified abstinent).
Time frame: 7 months
Self-reported motivation to quit smoking within 30 days. Participants who did not quit smoking (non-abstinent) during the study indicated whether they are ready to quit smoking within 30 days.
Time frame: 7 months
Self-reported attempts to quit smoking for at least 24 hours. Participants indicated whether they made any attempt to quit smoking for at least 24 hours because they were trying to quit (not due to illness or hospitalization)
Time frame: within 10 days after the dental clinic visit.
A 10-item questionnaire measuring satisfaction with the video experience (6 items) and satisfaction with the virtual reality (VR) headset experience (4 items). Each item is rated on a 1 ("not satisfied at all") to 7 ("very satisfied") scale and average scores are computed for each scale. Higher scores mean a better outcome.
Time frame: up to 7 months
The utilization index score (UIS) is computed as the sum of the utilization dose of each evidence-based treatment (EBT) for smoking cessation used by participants (range 0 - 100). Higher scores mean a better outcome.
Boston University
Other
Delivery of a Smoking Cessation Induction Intervention Via Virtual Reality (VR) Headset During a Dental Cleaning: Randomized Controlled Trial
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