AzTrials
AzTrials

Social Anxiety DisorderPhase 1NCT04260776

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

A Phase 1 study testing Phase 1: Web-based intervention (MyWebQuit) with 1-way text messages, Phase 1: Web-based intervention (MyWebQuit) with interactive, 2-way text messages and Phase 2: re-engagement text messages in people with Social Anxiety Disorder and Tobacco Use Disorder, run by Fred Hutchinson Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Social Anxiety Disorder, Tobacco Use Disorder
What is being tested?
Phase 1: Web-based intervention (MyWebQuit) with 1-way text messages, Phase 1: Web-based intervention (MyWebQuit) with interactive, 2-way text messages and Phase 2: re-engagement text messages
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
15 Apr 2022to 31 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
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
Medical subject headings
Phobia, Social, Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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 messagesBehavioural

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

  • Phase 2: re-engagement text messagesBehavioural

    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 emailsBehavioural

    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

Study groups in NCT04260776
Study groupRoleWhat they receive
Phase 1ExperimentalParticipants 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
Receives: 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 2ExperimentalFor 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
Receives: Behavioral: Phase 2: re-engagement text messages; Behavioral: Phase 2: re-engagement emails

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment

    Number of individuals screened, eligible, consented; reasons for ineligibility

    Measured: Recruitment

  2. Data retention

    Percentage of participants who complete outcome assessment at 3-months

    Measured: 3 months

  3. Acceptability of intervention and Phase 1 engagement components

    Treatment satisfaction ratings of the Phase 1 treatment conditions.

    Measured: 3 months

  4. Acceptability of intervention and Phase 2 engagement components

    Treatment satisfaction ratings of the Phase 2 treatment conditions

    Measured: 3 months

  5. Utilization of interactive messages

    Proportion of interactive text message prompts participants respond to

    Measured: 3 months

  6. Utilization of Phase 1 text messages

    Proportion of participants who unsubscribe from the Phase 1 text messages

    Measured: 3 months

  7. Website Utilization

    Total website logins

    Measured: 3 months

  8. Website Utilization

    Number of times disengagement criteria are met

    Measured: 3 months

  9. Website Utilization

    Percent of participants who login after rerandomization

    Measured: 3 months

Secondary outcomes (3)

  1. Self-reported 7-day point prevalence abstinence

    Preliminary efficacy for smoking cessation

    Measured: 3 months

  2. Self-reported 30-day point prevalence abstinence

    Preliminary efficacy for smoking cessation

    Measured: 3 months

  3. Biochemically confirmed smoking abstinence

    Preliminary efficacy for smoking cessation

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2020
  2. Study start15 Apr 2022 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Why it stopped: PI departure

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04260776
Sponsor's protocol ID
RG1006869
Other IDs
NCI-2020-00302, K23DA048181, 10384
Status last verified
Jun 2021
First submitted
5 Feb 2020
Last updated
8 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Phase 1: Web-based intervention (MyWebQuit) with 1-way text messages, Phase 1: Web-based intervention (MyWebQuit) with interactive, 2-way text messages and Phase 2: re-engagement text messages in people with Social Anxiety Disorder and Tobacco Use Disorder, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment (time frame: Recruitment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04260776.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in