Generalized and Domain-Specific Episodic Thinking for Smoking Cessation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorVirginia Polytechnic Institute and State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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.

  • 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).

Treatment groups

134 Participants
are divided into 4 treatment groups
Group A: Generalized episodic future thinking (EFT)Experimental treatment 2 interventions
Group B: Domain-specific episodic future thinking (EFT)Experimental treatment 2 interventions
Group C: Generalized episodic recent thinking (ERT)Placebo comparator 2 interventions
Group D: Domain-specific episodic recent thinking (ERT)Active comparator 2 interventions

Trial outcomes

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.

Time frame
From Week 0 to the end of treatment at 8 weeks

Secondary outcomes

1

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.

Time frame
From Week 0 to the end of treatment at 8 weeks
2

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.

Time frame
Week 8

Other outcomes

1

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.

Time frame
From Week 1 to the end of treatment at 8 weeks
2

Depressive symptoms (feasibility outcome)

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
3

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).

Time frame
From Week 0 to the end of treatment at 8 weeks
4

Episodic thinking adherence (feasibility outcome)

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

Sponsors and contacts

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Virginia Polytechnic Institute and State University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Roswell Park Comprehensive Cancer Center

Collaborator