This phase I trial will use a pilot sequential multiple assignment randomized trial (SMART) to examine protocol feasibility and acceptability of new components of a web-based intervention for socially anxious smokers. This study will be used to help build an adaptive treatment strategy to improve engagement with and effectiveness of the web-based intervention. Adaptive treatment strategies provide individualized sequences of intervention components to accommodate the changing needs of individuals based on their characteristics, treatment response, or engagement.
This study proposes to use a pilot SMART to help build an adaptive treatment strategy to improve engagement with and effectiveness of a web-based intervention for socially anxious smokers. At the outset of the study (Phase 1), participants will receive access to a new web-based smoking intervention (MyWebQuit) and will randomized to receive one of two text message services: 1) 1-way text messages, or 2) interactive, 2-way text messages. Those who disengage with the website in the first 5 weeks will be re-randomized to one of three re-engagement strategies: 1) re-engagement emails, 2) re-engagement interactive text messages, or 3) no re-engagement strategy. Outcomes include protocol feasibility, treatment acceptability, treatment utilization, and smoking cessation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Participants will receive MyWebQuit (web-based smoking intervention) along with a corresponding 1-way text messages
Participants will receive MyWebQuit (web-based smoking intervention) along with corresponding interactive, 2-way text messages
In addition to Phase 1 intervention components, 1/3 of participants who disengage with the website will receive interactive text messages designed to promote re-engagement
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Recruitment
Number of individuals screened, eligible, consented; reasons for ineligibility
Time frame: Recruitment
Data retention
Percentage of participants who complete outcome assessment at 3-months
Time frame: 3 months
Acceptability of intervention and Phase 1 engagement components
Treatment satisfaction ratings of the Phase 1 treatment conditions.
Time frame: 3 months
Acceptability of intervention and Phase 2 engagement components
Treatment satisfaction ratings of the Phase 2 treatment conditions
Time frame: 3 months
Utilization of interactive messages
Proportion of interactive text message prompts participants respond to
Time frame: 3 months
Utilization of Phase 1 text messages
Proportion of participants who unsubscribe from the Phase 1 text messages
Time frame: 3 months
Website Utilization
Total website logins
Time frame: 3 months
Website Utilization
Number of times disengagement criteria are met
Time frame: 3 months
Website Utilization
Percent of participants who login after rerandomization
Time frame: 3 months
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In addition to Phase 1 intervention components, 1/3 of participants who disengage with the website will receive a personalized email designed to promote re-engagement
Self-reported 7-day point prevalence abstinence
Preliminary efficacy for smoking cessation
Time frame: 3 months
Self-reported 30-day point prevalence abstinence
Preliminary efficacy for smoking cessation
Time frame: 3 months
Biochemically confirmed smoking abstinence
Preliminary efficacy for smoking cessation
Time frame: 3 months