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

NCT ID: NCT04260776

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-15

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Social Anxiety Disorder Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Participants will receive MyWebQuit (web-based smoking intervention) along with corresponding interactive, 2-way text messages

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

Group Type EXPERIMENTAL

Phase 2: re-engagement text messages

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Noreen Watson

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2020-00302

Identifier Type: REGISTRY

Identifier Source: secondary_id

K23DA048181

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10384

Identifier Type: OTHER

Identifier Source: secondary_id

RG1006869

Identifier Type: -

Identifier Source: org_study_id