Generalized and Domain-Specific Episodic Thinking for Smoking Cessation
2 other identifiers
interventional
134
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2025
CompletedFirst Posted
Study publicly available on registry
September 8, 2025
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
March 31, 2026
March 1, 2026
1 year
August 20, 2025
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cigarettes smoked per day
A timeline followback questionnaire will be used to assess the number of cigarettes smoked per day. Lower values reflect better outcomes.
From Week 0 to the end of treatment at 8 weeks
Secondary Outcomes (2)
Other tobacco/nicotine product use per day
From Week 0 to the end of treatment at 8 weeks
7-day point prevalence cigarette abstinence
Week 8
Other Outcomes (6)
Nicotine patch adherence (feasibility outcome)
From Week 1 to the end of treatment at 8 weeks
Depressive symptoms (feasibility outcome)
From Week 0 to the end of treatment at 8 weeks
Anxiety symptoms (feasibility outcome)
From Week 0 to the end of treatment at 8 weeks
- +3 more other outcomes
Study Arms (4)
Generalized episodic future thinking (EFT)
EXPERIMENTALThe Generalized EFT group will identify positive events that may occur at 6 future time points (1 month to 5 years). These may include a broad range of personally significant milestones (e.g., weddings, birthdays) or other events that participants are looking forward to (e.g., spending time with loved ones). Participants will also generate vivid text descriptions, or cues (transcribed in their own words), to prompt EFT in the natural environment. These cues, including emotional impacts, will be elicited using standardized questions: Who are you with? What are you doing? Where are you? How are you feeling? Participants will be prompted to engage in Generalized EFT in the natural environment.
Domain-specific episodic future thinking (EFT)
EXPERIMENTALThe Domain-Specific EFT group will complete an identical interview as the Generalized EFT group to identify positive future events, with one exception. Following initial cue generation, participants will be provided with descriptions of lung cancer symptoms (e.g., painful breathing; extreme fatigue; coughing up blood, phlegm, or mucus) and will be asked to visualize and include details related to this experience and their emotional impact in their revised cues. Thus, cancer-related symptoms occur in the context of otherwise positive, personally significant events to further highlight the impact of the diagnosis and to be consistent with Generalized EFT. Participants will be prompted to engage in Domain-Specific EFT in the natural environment.
Generalized episodic recent thinking (ERT)
PLACEBO COMPARATORThe Generalized ERT interview will be identical to the one described for Generalized EFT, except participants will describe positive events they experienced in the last week. Participants will be prompted to engage in Generalized ERT in the natural environment.
Domain-specific episodic recent thinking (ERT)
ACTIVE COMPARATORThe Domain-Specific ERT interview will be identical to the one described for Domain-Specific EFT, except participants will describe positive events they experienced in the last week and will subsequently add detail as though they were experiencing symptoms of lung cancer. Participants will be prompted to engage in Domain-Specific ERT in the natural environment.
Interventions
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).
Eligibility Criteria
You may qualify if:
- smoked cigarettes daily for the last 30 days;
- salivary cotinine \> 30 ng/mL, consistent with tobacco use;
- plan to quit smoking in the next 30 days
You may not qualify if:
- prior diagnosis with a smoking-related illness (e.g., respiratory disease);
- past 30-day use any smoking cessation treatment;
- anxiety or mood disorders; and
- medical contraindications for use of nicotine replacement therapy (e.g. pregnancy).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24015, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Stein, PhD
Virginia Polytechnic Institute and State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 20, 2025
First Posted
September 8, 2025
Study Start
May 1, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
March 31, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ICF, ANALYTIC CODE
- Time Frame
- Study data and supporting information will be available beginning 3 months and ending 5 years after the publication of results.
- Access Criteria
- All shared deidentified study data and supporting information will be available without restriction via a project-specific url.
All de-identified study data that are included in publication results will be shared using a project-specific url.