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

Fred Hutchinson Cancer Center (FHCC)

Status and phase: Withdrawn; Phase 1

Conditions: Tobacco Use Disorder; Social Anxiety Disorder

Treatments: Behavioral: Phase 1: Web-based intervention (MyWebQuit) with 1-way text messages; Behavioral: Phase 2: re-engagement emails; Behavioral: Phase 1: Web-based intervention (MyWebQuit) with interactive, 2-way text messages; Behavioral: Phase 2: re-engagement text messages

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04260776

K23DA048181 (U.S. NIH Grant/Contract)

10384

NCI-2020-00302 (Registry Identifier)

RG1006869

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Phase 1

Experimental group

Description:

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

Treatment:

Behavioral: Phase 1: Web-based intervention (MyWebQuit) with interactive, 2-way text messages

Behavioral: Phase 1: Web-based intervention (MyWebQuit) with 1-way text messages

Phase 2

Experimental group

Description:

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

Treatment:

Behavioral: Phase 2: re-engagement emails

Behavioral: Phase 2: re-engagement text messages