Social Anxiety Disorder, Tobacco Use Disorder
Conditions
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.
Interventions
BEHAVIORALPhase 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
BEHAVIORALPhase 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
BEHAVIORALPhase 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
BEHAVIORALPhase 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
Sponsors
National Institute on Drug Abuse (NIDA)
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Website Utilization | 3 months | Total website logins |
| Acceptability of intervention and Phase 2 engagement components | 3 months | Treatment satisfaction ratings of the Phase 2 treatment conditions |
| Utilization of interactive messages | 3 months | Proportion of interactive text message prompts participants respond to |
| Utilization of Phase 1 text messages | 3 months | Proportion of participants who unsubscribe from the Phase 1 text messages |
| Recruitment | Recruitment | Number of individuals screened, eligible, consented; reasons for ineligibility |
| Data retention | 3 months | Percentage of participants who complete outcome assessment at 3-months |
| Acceptability of intervention and Phase 1 engagement components | 3 months | Treatment satisfaction ratings of the Phase 1 treatment conditions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported 30-day point prevalence abstinence | 3 months | Preliminary efficacy for smoking cessation |
| Biochemically confirmed smoking abstinence | 3 months | Preliminary efficacy for smoking cessation |
| Self-reported 7-day point prevalence abstinence | 3 months | Preliminary efficacy for smoking cessation |
Countries
United States
Outcome results
None listed