Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04754867
Status:
WITHDRAWN
Last Update Posted:
2021-02-15
First Post:
2017-09-20
Brief Title:
Pre-Test of For the Future Self and Smoking Cessation
Sponsor:
Carnegie Mellon University
Organization:
Carnegie Mellon University
Study Overview
Official Title:
Pre-Test of For the Future Self A Behavioral Intervention to Increase Success in a Smoking Cessation Program
Status:
WITHDRAWN
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Never initiated PI has left the institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this experimental research is to increase adherence to a smoking cessation patch among Pittsburgh residents who are trying to quit smoking The literature on smoking cessation shows that there is a significant problem with adherence when using a transdermal patch as a nicotine replacement treatment Less than half of patients use the patch as prescribed and adherence suffers a rapid decline during the first six weeks of treatment Waldroup Gifford Kalra 2006 Recent work in psychology demonstrates that being more connected to our future selves enables better long-term decision making in part by making future rewards more salient and making present rewards less so To test whether a future selves intervention might facilitate patch adherence in a smoking cessation program investigators will recruit participants planning to begin using nicotine patches in local smoking cessation programs and randomly assign them to one of three conditions 1 discontinued-smoker age-progressed future self virtual reality images vs 2 discontinued-smoker continued smoking age-progressed future self virtual reality images vs 3 control - current self virtual reality images
Detailed Description:
Several factors are thought to be relevant to the level of adherence such as the initial level of nicotine addiction Orleans et al 1994 gender Gritz Nielsen Brooks 1996 concerns over weight gain due to smoking cessation Fagerström 2002 and side effects Burns Levinson 2008 On the other hand combining nicotine replacement treatment with behavioral therapy has been shown to improve adherence and overall abstinence Cooper et al 2004 and motivation is found to be an important factor related to patch use Alterman Gariti Cook Cnaan 1999
Can a more vivid connection to an individuals future self facilitate smoking cessation While behavioral interventions that enhance connection to the future self have been proven effective at mitigating present bias they have so far been done in domains that require self-restraint eg delinquency Smoking cessation does in part require restraint but a cessation program utilizing the nicotine patch also requires proactive daily commitment and action Little research has been done to establish the effectiveness of a future selves intervention on behaviors that require proactive action
Recent work in psychology demonstrates that being more connected to our future selves enables better long-term decision making in part by making future rewards more salient and making present rewards less so To test whether a future selves intervention might facilitate patch adherence in a smoking cessation program investigators will recruit participants planning to begin using nicotine patches in local smoking cessation programs and randomly assign them to one of three conditions 1 discontinued-smoker age-progressed future self virtual reality images vs 2 discontinued-smoker continued smoking age-progressed future self virtual reality images vs 3 control - current self virtual reality images Participants in the discontinued smoker age-progressed virtual reality condition will see two rendering of themselves in optimal health twenty years into the future a frontal and profile view participants in the discontinued smoker continued smoking age-progressed virtual reality condition will see two frontal renderings of themselves twenty years in the future one in optimal health and one incorporating appearance-related medical consequences of moderate-heavy smoking over twenty years eg skin that is dry and discolored increased wrinkles etc participants in the current self virtual reality condition will see their present age self in a virtual reality rendering Participants in all conditions will write a 200-300 word letter to themselves in the treatment condition the letter is written to their self in 20 years in control the letter is written to themselves in 3 months The investigators will measure the impact of the behavioral intervention on participants expected efficacy with smoking cessation self-reported patch adherence and smoking cessation success 2 and 8 weeks later
The investigators will collect self-reported and non-invasive physiological adherence data over the course of 8 weeks on participants adherence to the nicotine patch self-report and success with smoking cessation self-report and CO analysis For those participants self-reporting zero cigarettes smoked in the 7 day period before lab visits investigators will administer a breath CO assessment a simple procedure where the participant breathes into a tube and the device analyzes how many carbon dioxide parts per million are in the breath The investigators will also asks participants if they would be willing to receive an email invitation to an online 3-question 6-month follow-up survey to occur four months after their last in-person visit to the laboratory
The data collected will not be tied to identifiers it will be used in statistical analyses assessing the effects of the intervention
Can a more vivid connection to an individuals future self facilitate smoking cessation While behavioral interventions that enhance connection to the future self have been proven effective at mitigating present bias they have so far been done in domains that require self-restraint eg delinquency Smoking cessation does in part require restraint but a cessation program utilizing the nicotine patch also requires proactive daily commitment and action Little research has been done to establish the effectiveness of a future selves intervention on behaviors that require proactive action
Recent work in psychology demonstrates that being more connected to our future selves enables better long-term decision making in part by making future rewards more salient and making present rewards less so To test whether a future selves intervention might facilitate patch adherence in a smoking cessation program investigators will recruit participants planning to begin using nicotine patches in local smoking cessation programs and randomly assign them to one of three conditions 1 discontinued-smoker age-progressed future self virtual reality images vs 2 discontinued-smoker continued smoking age-progressed future self virtual reality images vs 3 control - current self virtual reality images Participants in the discontinued smoker age-progressed virtual reality condition will see two rendering of themselves in optimal health twenty years into the future a frontal and profile view participants in the discontinued smoker continued smoking age-progressed virtual reality condition will see two frontal renderings of themselves twenty years in the future one in optimal health and one incorporating appearance-related medical consequences of moderate-heavy smoking over twenty years eg skin that is dry and discolored increased wrinkles etc participants in the current self virtual reality condition will see their present age self in a virtual reality rendering Participants in all conditions will write a 200-300 word letter to themselves in the treatment condition the letter is written to their self in 20 years in control the letter is written to themselves in 3 months The investigators will measure the impact of the behavioral intervention on participants expected efficacy with smoking cessation self-reported patch adherence and smoking cessation success 2 and 8 weeks later
The investigators will collect self-reported and non-invasive physiological adherence data over the course of 8 weeks on participants adherence to the nicotine patch self-report and success with smoking cessation self-report and CO analysis For those participants self-reporting zero cigarettes smoked in the 7 day period before lab visits investigators will administer a breath CO assessment a simple procedure where the participant breathes into a tube and the device analyzes how many carbon dioxide parts per million are in the breath The investigators will also asks participants if they would be willing to receive an email invitation to an online 3-question 6-month follow-up survey to occur four months after their last in-person visit to the laboratory
The data collected will not be tied to identifiers it will be used in statistical analyses assessing the effects of the intervention
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