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

Primary Purpose

Social Anxiety Disorder, Tobacco Use Disorder

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Phase 1: Web-based intervention (MyWebQuit) with 1-way text messages
Phase 1: Web-based intervention (MyWebQuit) with interactive, 2-way text messages
Phase 2: re-engagement text messages
Phase 2: re-engagement emails
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Social Anxiety Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phase 1

Phase 2

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Self-reported 7-day point prevalence abstinence
Preliminary efficacy for smoking cessation
Self-reported 30-day point prevalence abstinence
Preliminary efficacy for smoking cessation
Biochemically confirmed smoking abstinence
Preliminary efficacy for smoking cessation

Full Information

First Posted
February 5, 2020
Last Updated
November 24, 2021
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04260776
Brief Title
Adaptive Treatment Strategies for Improving Engagement With a Web-Based Smoking Intervention in Socially Anxious Smokers
Official Title
A SMART Pilot of Adaptive Treatment Strategies to Improve Engagement With a Web-Based Intervention for Socially Anxious Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
PI departure
Study Start Date
April 15, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder, Tobacco Use Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1
Arm Type
Experimental
Arm 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
Arm Title
Phase 2
Arm Type
Experimental
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
Phase 1: Web-based intervention (MyWebQuit) with 1-way text messages
Intervention Description
Participants will receive MyWebQuit (web-based smoking intervention) along with a corresponding 1-way text messages
Intervention Type
Behavioral
Intervention Name(s)
Phase 1: Web-based intervention (MyWebQuit) with interactive, 2-way text messages
Intervention Description
Participants will receive MyWebQuit (web-based smoking intervention) along with corresponding interactive, 2-way text messages
Intervention Type
Behavioral
Intervention Name(s)
Phase 2: re-engagement text messages
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Phase 2: re-engagement emails
Intervention Description
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
Primary Outcome Measure Information:
Title
Recruitment
Description
Number of individuals screened, eligible, consented; reasons for ineligibility
Time Frame
Recruitment
Title
Data retention
Description
Percentage of participants who complete outcome assessment at 3-months
Time Frame
3 months
Title
Acceptability of intervention and Phase 1 engagement components
Description
Treatment satisfaction ratings of the Phase 1 treatment conditions.
Time Frame
3 months
Title
Acceptability of intervention and Phase 2 engagement components
Description
Treatment satisfaction ratings of the Phase 2 treatment conditions
Time Frame
3 months
Title
Utilization of interactive messages
Description
Proportion of interactive text message prompts participants respond to
Time Frame
3 months
Title
Utilization of Phase 1 text messages
Description
Proportion of participants who unsubscribe from the Phase 1 text messages
Time Frame
3 months
Title
Website Utilization
Description
Total website logins
Time Frame
3 months
Title
Website Utilization
Description
Number of times disengagement criteria are met
Time Frame
3 months
Title
Website Utilization
Description
Percent of participants who login after rerandomization
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Self-reported 7-day point prevalence abstinence
Description
Preliminary efficacy for smoking cessation
Time Frame
3 months
Title
Self-reported 30-day point prevalence abstinence
Description
Preliminary efficacy for smoking cessation
Time Frame
3 months
Title
Biochemically confirmed smoking abstinence
Description
Preliminary efficacy for smoking cessation
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noreen Watson
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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