Adaptive Treatment Strategies for Improving Engagement With a Web-Based Smoking Intervention in Socially Anxious Smokers

Phase 1

Withdrawn

• Conditions: Social Anxiety Disorder; Tobacco Use Disorder

• Registration Number: NCT04260776
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

Study Timeline

• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-07
• Status Verified: 2021-06
• Last Update Submitted: 2021-11-24
• Last Update Posted: 2021-12-08
• Study Start: 2022-04-15
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Utilization of Phase 1 text messages	3 months	Proportion of participants who unsubscribe from the Phase 1 text messages
Website Utilization	3 months	Percent of participants who login after rerandomization
Recruitment	Recruitment	Number of individuals screened, eligible, consented; reasons for ineligibility
Data retention	3 months	Percentage of participants who complete outcome assessment at 3-months
Acceptability of intervention and Phase 2 engagement components	3 months	Treatment satisfaction ratings of the Phase 2 treatment conditions
Utilization of interactive messages	3 months	Proportion of interactive text message prompts participants respond to
Acceptability of intervention and Phase 1 engagement components	3 months	Treatment satisfaction ratings of the Phase 1 treatment conditions.

Secondary Outcome Measures

Name	Time	Method
Biochemically confirmed smoking abstinence	3 months	Preliminary efficacy for smoking cessation
Self-reported 7-day point prevalence abstinence	3 months	Preliminary efficacy for smoking cessation
Self-reported 30-day point prevalence abstinence	3 months	Preliminary efficacy for smoking cessation

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States