Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04838236
Status:
RECRUITING
Last Update Posted:
2023-01-20
First Post:
2021-03-25
Brief Title:
Smoking Stress and Mobile Technology
Sponsor:
University of Houston
Organization:
University of Houston
Study Overview
Official Title:
Improving Access to Cigarette Cessation Treatment Among African American Smokers Development and Evaluation of an Integrated mHealth Application
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We seek to refine and evaluate the novel mobile intervention Mobile Anxiety Sensitivity Program for Smoking MASP which was initially developed and previously tested by our team targeting sensitivity to interoceptive stress and to apply it among African American smokers Our culturally adapted intervention is framed within a sociocultural context of interoceptive stress which is supported by theory empirical evidence and characteristics of African American smokers The MASP app contains educational content on the history of tobacco and the African American community
Detailed Description:
The objective of the current trial is to refine and conduct a comprehensive cultural adaptation of an initially tested novel mobile intervention that targets anxiety sensitivity AS among African American smokers MASP The MASP app checks in with users throughout the day to assess their mood whether or not theyre experiencing any cravings or withdrawal symptoms and their overall mental health When users indicate they are struggling with staying abstinent or if they are experiencing heighted levels of stress or anxiety the app selects and delivers a tailored message from its library of hundreds of messages and videos For instance if a user indicates they are struggling with nicotine cravings and feel as though they are about to smoke they will receive an individually tailored suggestion on how to cope with the feeling and strategies to act and overcome it The app also contains videos that are designed to teach relaxation techniques as well as training exercises that teach participants how to cope with uncomfortable feelings of stress and nicotine withdrawal they are likely to experience while quitting nicotine The MASP app has the potential to deliver highly effective and accessible treatment to individuals who are looking to take that major step in their life and quit smoking for good
Individuals interested in participating in the study will complete informed consent and a study screener via RedCap and phone call with study staff signatures will be obtained digitally via RedCap Those found eligible during the phone screener will download the Insight app onto their personal phone to confirm compatibility and complete the baseline assessment Those who do not possess a phone that is compatible with the Insight platform will be mailed a compatible phone so they can complete the baseline assessment Upon completion of the baseline survey participants will be mailed a Bedfont Carbon Monoxide monitor iCO that can be used to remotely verify smoking status a Greenphire Mastercard and 4 weeks of NRT Upon receipt of the iCO participants will complete a brief phone call to walk them through the use of the iCO and study app Participants N25 in phase II will be in the study for a total of 6 weeks Upon completion of Phase II we will analyze data and utilize feedback collected from phase II participants to create MASP 30 We will then begin phase III of the study Participants N220 in the study will receive either the MASP 30 or QuitGuide plus EMA app following the completion of the baseline assessment Specifically following completion on the baseline assessment they will receive a unique code that they will type into the app to place them in the group that they were randomized to All participants will complete app-based follow-up assessments 1 2 quit day 3 4 5 6 28 and 54 weeks after the baseline visit We expect phase III of the study will be completed within a period of 30-36 months
Individuals interested in participating in the study will complete informed consent and a study screener via RedCap and phone call with study staff signatures will be obtained digitally via RedCap Those found eligible during the phone screener will download the Insight app onto their personal phone to confirm compatibility and complete the baseline assessment Those who do not possess a phone that is compatible with the Insight platform will be mailed a compatible phone so they can complete the baseline assessment Upon completion of the baseline survey participants will be mailed a Bedfont Carbon Monoxide monitor iCO that can be used to remotely verify smoking status a Greenphire Mastercard and 4 weeks of NRT Upon receipt of the iCO participants will complete a brief phone call to walk them through the use of the iCO and study app Participants N25 in phase II will be in the study for a total of 6 weeks Upon completion of Phase II we will analyze data and utilize feedback collected from phase II participants to create MASP 30 We will then begin phase III of the study Participants N220 in the study will receive either the MASP 30 or QuitGuide plus EMA app following the completion of the baseline assessment Specifically following completion on the baseline assessment they will receive a unique code that they will type into the app to place them in the group that they were randomized to All participants will complete app-based follow-up assessments 1 2 quit day 3 4 5 6 28 and 54 weeks after the baseline visit We expect phase III of the study will be completed within a period of 30-36 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None