Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24015, United States
NCT Number: NCT07158749
Cigarette smoking remains common, particularly in rural areas, despite ample evidence that smoking causes cancer and respiratory disease. Successful smoking cessation yields the majority of its health benefits (e.g., avoidance of lung cancer) after years of sustained behavioral change; however, people who smoke cigarettes tend to show elevated rates of delay discounting (i.e., devaluation of delayed outcomes) and a bias for immediate gratification. The overall goal of this project is to develop different versions of an episodic future thinking intervention (i.e., visualization of the future) and test their feasibility and efficacy for smoking cessation in rural and urban populations.
Trial opening soon.
Get Notified21 year and older
All sexes
Interventional
Not applicable
Roanoke, Virginia, 24015, United States
Cigarette smoking causes more than a dozen cancers, including cancers of the head and neck, colon, bladder, and lung. Although quitting smoking drastically reduces the risk of cancer mortality, rates of cessation are low, particularly in rural areas and other communities. Current evidence-based treatments for smoking cessation have made progress, but substantial room for innovation remains and novel strategies are needed. Successful smoking cessation may be considered, in part, an intertemporal choice between continuing to smoke and achieving the delayed health benefits associated with quitting (e.g., avoidance of lung cancer). Thus, quitting requires one's behavior to be sufficiently motivated by future outcomes. Unfortunately, robust cross-sectional and longitudinal evidence indicates that people who smoke cigarettes show elevated delay discounting, or a bias for immediate gratification. Prior research shows that delay discounting predicts treatment failure and relapse in smoking cessation. These findings suggest that delay discounting often prevents successful quitting because the health benefits of cessation (e.g., avoiding cancer) are too delayed to motivate sustained behavioral change. Thus, delay discounting is a therapeutic target in smoking cessation, where interventions that increase valuation of future outcomes may facilitate quitting. Episodic future thinking (EFT) is one such scalable intervention that is designed to shift time perspective and reduce bias for immediate gratification by promoting vivid and frequent visualization of a broad range of personally significant future events (e.g., weddings, birthdays, spending time with loved ones). In laboratory studies, research has shown that this form of generalized EFT in cigarette smokers reduces delay discounting and motivation to smoke (i.e., cigarette consumption, craving, and valuation). Moreover, strong preliminary evidence suggests that cancer-related EFT, a novel form of the intervention that involves visualizing the future experience of smoking-related lung cancer, may be more efficacious for reducing urges to smoke than the generalized form. The proposed trial will adapt both forms of EFT (generalized and cancer-related) for clinical use in smoking cessation. Remote intervention delivery and outcomes assessment (breath carbon monoxide and number of cigarettes smoked per day) will be used to minimize clinical burden and increase intervention reach and access, including in rural populations who often lack access to evidence-based treatments for smoking cessation. In an eight-week proof-of-concept trial, participants will be prompted to engage in EFT or control episodic thinking multiple times per day and during acute craving episodes. Specific Aims 1 and 2 will examine the feasibility and efficacy, respectively, of generalized and cancer-related EFT to reduce smoking. An Exploratory Aim will investigate the potential moderating role of income, education, sex, and other characteristics (e.g., baseline delay discounting, cigarettes/day) in the effects of EFT on smoking outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will engage in EFT for 8 weeks, three times a day. Participants will receive three daily text messages. Each prompt will link to a custom web interface that guides participants to read and vividly imagine one of their cues, chosen randomly. Visit times and durations will be recorded.
Participants will engage in ERT for 8 weeks, three times a day. Participants will receive three daily text messages. Each prompt will link to a custom web interface that guides participants to read and vividly imagine one of their cues, chosen randomly. Visit times and durations will be recorded.
Content of the episodic thinking intervention will experiencing the symptoms of lung cancer during a broad range of personally meaningful, otherwise positive, events (e.g., social events, celebrations, spending times with friends and family).
Content of the episodic thinking intervention will include a broad range of personally meaningful, positive, events (e.g., social events, celebrations, spending times with friends and family).
Time frame: From Week 0 to the end of treatment at 8 weeks
A timeline followback questionnaire will be used to assess the number of cigarettes smoked per day. Lower values reflect better outcomes.
Time frame: From Week 0 to the end of treatment at 8 weeks
A timeline followback questionnaire will be used to assess the number of times participants use other tobacco/nicotine products per day (excluding cigarettes and nicotine patch). Lower values reflect better outcomes.
Time frame: Week 8
A timeline followback questionnaire will be used to assess cigarette abstinence status (binary) over the final seven days of the intervention.
Time frame: From Week 1 to the end of treatment at 8 weeks
A timeline followback questionnaire will be used to assess frequency of use of the study-provided nicotine patches. Higher values reflect better adherence to nicotine replacement therapy.
Time frame: From Week 0 to the end of treatment at 8 weeks
Depression symptoms over the last 2 weeks will be assessed using the Patient Health Questionnaire-8 (PHQ-8). Total scores on this scale range from 0 (no depressive symptoms) to 24 (severe depressive symptoms).
Time frame: From Week 0 to the end of treatment at 8 weeks
Anxiety symptoms over the last 2 weeks will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Total scores on this scale range from 0 (no anxiety symptoms) to 21 (severe anxiety symptoms).
Time frame: From Week 1 to the end of treatment at 8 weeks
Adherence to the episodic thinking interventions will be measured as the percentage of daily cue prompts that participants access.
Time frame: From Week 1 to the end of treatment at 8 weeks
Participants will evaluate perceived convenience of the intervention, both overall and its individual components, using visual analog scales with ratings ranging from 0 to 100. Higher ratings reflect greater convenience
Time frame: From Week 1 to the end of treatment at 8 weeks
Participants will evaluate perceived helpfulness of the intervention, both overall and its individual components, using visual analog scales with ratings ranging from 0 to 100. Higher ratings reflect greater helpfulness.
Contact information is provided by the study sponsor or research team.
Virginia Polytechnic Institute and State University
Other
Generalized and Domain-Specific Episodic Thinking for Smoking Cessation: An 8-Week Pilot and Feasibility Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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