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

A SMART Pilot of Adaptive Treatment Strategies to Improve Engagement With a Web-Based Intervention for Socially Anxious Smokers

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.

Study Overview

• Status: Withdrawn
• Conditions: Tobacco Use Disorder; Social Anxiety Disorder
• Intervention / Treatment: Behavioral: Phase 1: Web-based intervention (MyWebQuit) with 1-way text messages; Behavioral: Phase 1: Web-based intervention (MyWebQuit) with interactive, 2-way text messages; Behavioral: Phase 2: re-engagement text messages; Behavioral: Phase 2: re-engagement emails

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 Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported 7-day point prevalence abstinence	Preliminary efficacy for smoking cessation	3 months
Self-reported 30-day point prevalence abstinence	Preliminary efficacy for smoking cessation	3 months
Biochemically confirmed smoking abstinence	Preliminary efficacy for smoking cessation	3 months

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Noreen Watson, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Phobic Disorders; Disease; Anxiety Disorders; Tobacco Use Disorder; Phobia, Social
• Other Study ID Numbers: RG1006869; 10384 (Other Identifier: CTEP); NCI-2020-00302 (Registry Identifier: NCI / CTRP); K23DA048181 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No