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

NCT04260776 | Withdrawn Phase 1

• 4 other identifiers: RG1006869NCI-2020-00302K23DA04818110384
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder; Tobacco Use Disorder

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (3)

• Self-reported 7-day point prevalence abstinence

  3 months

• Self-reported 30-day point prevalence abstinence

  3 months

• Biochemically confirmed smoking abstinence

  3 months

Study Arms (2)

Phase 1

EXPERIMENTAL

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

Phase 2

EXPERIMENTAL

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; Behavioral: Phase 2: re-engagement emails

Interventions

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

Participants will receive MyWebQuit (web-based smoking intervention) along with a corresponding 1-way text messages

Phase 1

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

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

Phase 1

Phase 2: re-engagement text messages 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

Phase 2: re-engagement emails 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

Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Phobia, Social; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Noreen Watson

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 7, 2020
• Study Start: April 15, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)