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

Tobacco Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04260776
• Other study ID #: RG1006869
• Secondary ID: NCI-2020-00302K2
• Status: Withdrawn
• Phase: Phase 1
• Start date: April 15, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2021
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Phobia, Social
• Social Anxiety Disorder
• Tobacco Use Disorder

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Number of individuals screened, eligible, consented; reasons for ineligibility	Recruitment
Primary	Data retention	Percentage of participants who complete outcome assessment at 3-months	3 months
Primary	Acceptability of intervention and Phase 1 engagement components	Treatment satisfaction ratings of the Phase 1 treatment conditions.	3 months
Primary	Acceptability of intervention and Phase 2 engagement components	Treatment satisfaction ratings of the Phase 2 treatment conditions	3 months
Primary	Utilization of interactive messages	Proportion of interactive text message prompts participants respond to	3 months
Primary	Utilization of Phase 1 text messages	Proportion of participants who unsubscribe from the Phase 1 text messages	3 months
Primary	Website Utilization	Total website logins	3 months
Primary	Website Utilization	Number of times disengagement criteria are met	3 months
Primary	Website Utilization	Percent of participants who login after rerandomization	3 months
Secondary	Self-reported 7-day point prevalence abstinence	Preliminary efficacy for smoking cessation	3 months
Secondary	Self-reported 30-day point prevalence abstinence	Preliminary efficacy for smoking cessation	3 months
Secondary	Biochemically confirmed smoking abstinence	Preliminary efficacy for smoking cessation	3 months