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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-00302 | Registry Identifier | NCI / CTRP | |
| K23DA048181 | U.S. NIH Grant/Contract | View source | |
| 10384 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noreen Watson | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| 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 |
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| 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 |
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| 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 |
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| Website Utilization | Percent of participants who login after rerandomization | 3 months |
| 3 months |
| Biochemically confirmed smoking abstinence | Preliminary efficacy for smoking cessation | 3 months |
| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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