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

Study Overview
=================
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.

Official Title
-----------------
A SMART Pilot of Adaptive Treatment Strategies to Improve Engagement With a Web-Based Intervention for Socially Anxious Smokers

Conditions
-----------------
Social Anxiety Disorder, Tobacco Use Disorder

Intervention / Treatment
-----------------
* 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
* Behavioral: Phase 2: re-engagement text messages
* Behavioral: Phase 2: re-engagement emails


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1<br>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<br>* Participants will receive MyWebQuit (web-based smoking intervention) along with a corresponding 1-way text messages<br>Behavioral: Phase 1: Web-based intervention (MyWebQuit) with interactive, 2-way text messages<br>* Participants will receive MyWebQuit (web-based smoking intervention) along with corresponding interactive, 2-way text messages<br>|
| Experimental: Phase 2<br>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<br>* 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<br>Behavioral: Phase 2: re-engagement emails<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported 7-day point prevalence abstinence | Preliminary efficacy for smoking cessation | 3 months | 
| Self-reported 30-day point prevalence abstinence | Preliminary efficacy for smoking cessation | 3 months | 
| Biochemically confirmed smoking abstinence | Preliminary efficacy for smoking cessation | 3 months |