VR Smoking Cessation During a Dental Hygiene Visit

Smoking Cessation Clinical Trial

Official title: Delivery of a Smoking Cessation Induction Intervention Via Virtual Reality (VR) Headset During a Dental Cleaning: Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Smoking Cessation

• NCT number: NCT04524533
• Study type: Interventional
• Source: Boston University
• Contact: Belinda Borrelli, PhD
• Phone: 617-358-3358
• Email: belindab@bu.edu
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2021
• Completion date: March 2025