Clinical trial NCT04260776: Adaptive Treatment Strategies for Improving Engagement With a Web-Based Smoking Intervention in Socially Anxious Smokers
Official title: A SMART Pilot of Adaptive Treatment Strategies to Improve Engagement With a Web-Based Intervention for Socially Anxious Smokers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Social Anxiety Disorder
Tobacco Use Disorder
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-02-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.

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
* no prior participation in one of the investigator's prior smoking cessation studies,
* comfortable reading, writing, and speaking English
* agree to the conditions of compensation
* not currently incarcerated in a prison
* willing to use the MyWebQuit program, complete study assessments, and sign an online consent form
* no other member of their same household participating in the study

Primary outcomes:
measure: Recruitment
timeFrame: Recruitment
measure: Data retention
timeFrame: 3 months
measure: Acceptability of intervention and Phase 1 engagement components
timeFrame: 3 months
measure: Acceptability of intervention and Phase 2 engagement components
timeFrame: 3 months
measure: Utilization of interactive messages
timeFrame: 3 months
measure: Utilization of Phase 1 text messages
timeFrame: 3 months
measure: Website Utilization
timeFrame: 3 months
measure: Website Utilization
timeFrame: 3 months
measure: Website Utilization
timeFrame: 3 months
Secondary outcomes:
measure: Self-reported 7-day point prevalence abstinence
timeFrame: 3 months
measure: Self-reported 30-day point prevalence abstinence
timeFrame: 3 months
measure: Biochemically confirmed smoking abstinence
timeFrame: 3 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Noreen Watson
role: PRINCIPAL_INVESTIGATOR
References: