Adaptive Treatment Strategies for Improving Engagement With a Web-Based Smoking Intervention in Socially Anxious Smokers
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Phase 1 Participants will be randomly assigned to one of the two text message programs that correspond with the web-based intervention (MyWebQuit): 1) standard, 1-way text messages, or 2) interactive, 2-way text messages |
Behavioral: Phase 1: Web-based intervention (MyWebQuit) with 1-way text messages
Participants will receive MyWebQuit (web-based smoking intervention) along with a corresponding 1-way text messages
Behavioral: Phase 1: Web-based intervention (MyWebQuit) with interactive, 2-way text messages
Participants will receive MyWebQuit (web-based smoking intervention) along with corresponding interactive, 2-way text messages
|
| Experimental: Phase 2 For the first 5 weeks after randomization, engagement with the website will be monitored. Participants who continue to engage with the website will continue with the same Phase 1 treatment components until the 3-month follow-up. Participants who disengage with the website will be randomly assigned to receive one of three re-engagement strategies: 1) interactive, re-engagement text messages, 2) re-engagement email, or 3) no re-engagement strategy |
Behavioral: Phase 2: re-engagement 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
Behavioral: Phase 2: re-engagement emails
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
|
Outcome Measures
Primary Outcome Measures
- 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 1 engagement components [3 months]
Treatment satisfaction ratings of the Phase 1 treatment conditions.
- 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
- Utilization of Phase 1 text messages [3 months]
Proportion of participants who unsubscribe from the Phase 1 text messages
- Website Utilization [3 months]
Total website logins
- Website Utilization [3 months]
Number of times disengagement criteria are met
- Website Utilization [3 months]
Percent of participants who login after rerandomization
Secondary Outcome Measures
- 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
- Biochemically confirmed smoking abstinence [3 months]
Preliminary efficacy for smoking cessation
Eligibility Criteria
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
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screen positive for social anxiety (LSAS-SR ≥ 60)
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interested in participating in the study for themselves (versus [vs] someone else)
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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
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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
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no other member of their same household participating in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | United States | 98109 |
Sponsors and Collaborators
- Fred Hutchinson Cancer Center
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Noreen Watson, Fred Hutch/University of Washington Cancer Consortium
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RG1006869
- NCI-2020-00302
- K23DA048181
- 10384