A SMART Pilot of Adaptive Treatment Strategies to Improve Engagement With a Web-Based Intervention for Socially Anxious Smokers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Social Anxiety Disorder
- Sponsor
- Fred Hutchinson Cancer Center
- Locations
- 1
- Primary Endpoint
- Utilization of Phase 1 text messages
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •resides in the US and anticipates remaining in the US for the duration of the study
- •smokes at least 5 cigarettes per day for at least 12 months prior to screening
- •desire to quit smoking within 30 days
- •has at least weekly internet access
- •current use of a personal email account
- •current use of text messaging
- •willing to receive text messages as part of this study
- •screen positive for social anxiety (LSAS-SR ≥ 60)
- •interested in participating in the study for themselves (versus \[vs\] someone else)
- •not currently taking part in any other smoking cessation treatment such as the nicotine patch, nicotine gum, Zyban, in-person counseling, telephone counseling, using a web-based or app-based cessation program
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Utilization of Phase 1 text messages
Time Frame: 3 months
Proportion of participants who unsubscribe from the Phase 1 text messages
Website Utilization
Time Frame: 3 months
Percent of participants who login after rerandomization
Recruitment
Time Frame: Recruitment
Number of individuals screened, eligible, consented; reasons for ineligibility
Data retention
Time Frame: 3 months
Percentage of participants who complete outcome assessment at 3-months
Acceptability of intervention and Phase 2 engagement components
Time Frame: 3 months
Treatment satisfaction ratings of the Phase 2 treatment conditions
Utilization of interactive messages
Time Frame: 3 months
Proportion of interactive text message prompts participants respond to
Acceptability of intervention and Phase 1 engagement components
Time Frame: 3 months
Treatment satisfaction ratings of the Phase 1 treatment conditions.
Secondary Outcomes
- Biochemically confirmed smoking abstinence(3 months)
- Self-reported 7-day point prevalence abstinence(3 months)
- Self-reported 30-day point prevalence abstinence(3 months)