Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA294049 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Roswell Park Comprehensive Cancer Center | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Generalized episodic future thinking (EFT) | Experimental | The 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) | Experimental | The 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 Comparator | The 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Episodic Future Thinking (EFT) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Other tobacco/nicotine product use per day | 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. | From Week 0 to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine patch adherence (feasibility outcome) | 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. | From Week 1 to the end of treatment at 8 weeks |
| Depressive symptoms (feasibility outcome) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Stein, PhD | Contact | 15405262124 | jstein1@vtc.vt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Stein, PhD | Virginia Polytechnic Institute and State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fralin Biomedical Research Institute at VTC | Roanoke | Virginia | 24015 | United States |
All de-identified study data that are included in publication results will be shared using a project-specific url.
Study data and supporting information will be available beginning 3 months and ending 5 years after the publication of results.
All shared deidentified study data and supporting information will be available without restriction via a project-specific url.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Domain-specific episodic recent thinking (ERT) | Active Comparator | The 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. |
|
|
| Episodic Recent Thinking (ERT) | Behavioral | 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. |
|
| Domain-specific episodic thinking | Behavioral | 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). |
|
| Generalized episodic thinking | Behavioral | 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). |
|
| 7-day point prevalence cigarette abstinence |
A timeline followback questionnaire will be used to assess cigarette abstinence status (binary) over the final seven days of the intervention. |
| Week 8 |
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). |
| From Week 0 to the end of treatment at 8 weeks |
| Anxiety symptoms (feasibility outcome) | 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). | From Week 0 to the end of treatment at 8 weeks |
| Episodic thinking adherence (feasibility outcome) | Adherence to the episodic thinking interventions will be measured as the percentage of daily cue prompts that participants access. | From Week 1 to the end of treatment at 8 weeks |
| Perceived convenience (feasibility outcome) | 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 | From Week 1 to the end of treatment at 8 weeks |
| Perceived helpfulness (feasibility outcome) | 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. | From Week 1 to the end of treatment at 8 weeks |
| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
Not provided
Not provided