NCT03431324

Brief Summary

The current proposal aims to develop and establish the effectiveness of a novel behavioral smoking cessation intervention. Previous research has shown that having smokers engage in episodic future thinking (EFT) about specific positive life outcomes that they could experience if they quit smoking immediately can be an effective means of reducing cigarette consumption. This intervention allowed participants to generate their own general positive life outcomes. While the existing intervention approaches motivation from a generalist perspective, the current proposal seeks to modify this intervention to fit within a Fundamental Social Motives (FSM) framework. The FSM framework posits that there exist individual differences in fundamental social motives such as self-protection, disease avoidance, affiliation, kin care, and mating motives such that some individuals are more motivated to work toward some of these goals than others. Specifically, the current proposal seeks to develop an EFT intervention that appeals to fundamental mating motives by asking participants to imagine positive mating outcomes that they might experience in one year's time if they were to quit smoking immediately. This will be accomplished via two empirical studies. Study 1 will compare the effectiveness of the mating-EFT intervention to the general-EFT intervention and a yoked control condition while examining the possibility that individual differences in relationship status, mating motives, self-efficacy, and nicotine dependence moderate these effects. Study 2 will employ a quasi-experimental design to test the effectiveness of this intervention using a tailored messaging approach, assigning smokers who are either single and motivated to seek new mates or involved in a committed relationship and not motivated to seek new mates to complete the general or mating-EFT or a control task. The investigators predict that the mating-EFT will be more effective than the general EFT in reducing cigarette consumption, particularly if it is administered to participants who have more active mating goals.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Status
unknown

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

February 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

February 7, 2018

Last Update Submit

February 12, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cigarette Consumption

    During the initial session, participants will be asked to report how many cigarettes they smoke during a typical week. This will serve as a baseline to which the number of cigarettes smoked following exposure to the interventions will be compared. This within-subjects comparison will complement the between-subjects comparison that will be used in order to test the effectiveness of the manipulation within each group.

    7 days

Secondary Outcomes (1)

  • Motivation to Quit or Reduce Smoking

    7 days

Study Arms (2)

Mating-EFT Intervention Effectiveness

EXPERIMENTAL

Study 1: 90 participants will attend an initial session, at which point they will provide demographic information as well as their relationship status. They will then be randomly assigned to complete either the Episodic Future Thinking about Mating Opportunities intervention, a general-EFT intervention, or an unrelated questionnaire (yoked control condition). All participants will submit daily reports of the number of cigarettes smoked for a period of one week. Participants will then complete a series of questionnaires measuring individual differences in fundamental social motives (including mate-seeking motives), self-efficacy, and nicotine dependence.

Behavioral: Episodic Future Thinking about Mating Opportunities

Message Tailoring for Smoking Cessation

EXPERIMENTAL

Study 2: A quasi-experimental design will be employed in order to determine whether targeting individuals who are single and highly motivated to seek a mate with a Targeted Mating-EFT Intervention is a more effective means of reducing cigarette consumption than presenting all individuals with a general-EFT intervention. A total of 180 smokers who intend to quit or reduce smoking will be recruited as participants. These individuals will be selected from a larger pool of participants based upon responses to screening questions. The screening questions will measure relationship status and mate seeking motivation.

Behavioral: Targeted Mating-EFT Intervention

Interventions

Participants who complete the mating-EFT intervention will be instructed to write about three positive mating-related events that would occur within the course of one year "if you successfully quit smoking now." Participants will then be asked to close their eyes and imagine the events that they listed as specifically and vividly as possible (e.g., to imagine the setting and the sequence of the events, as well as the persons and objects that would be present. A period of one minute will be allotted for participants to mentally pre-experience each event. The general-EFT intervention will be structured similarly to, with the key exception of being instructed to write about and imagine three "positive life events".

Mating-EFT Intervention Effectiveness

This intervention is identical to the "Episodic Future Thinking about Mating Opportunities" intervention with the exception that in Arm 2 the aim will be to determine whether the Mating-EFT intervention is especially effective when administered to individuals who are single or highly motivated to seek a mate.

Message Tailoring for Smoking Cessation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Fluent in English
  • Current smoker
  • Motivated to quit or reduce their cigarette consumption

You may not qualify if:

  • Under 18 years of age
  • Not fluent in English
  • Not currently a smoker
  • Not motivated to quit or reduce cigarette consumption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chiou WB, Wu WH. Episodic Future Thinking Involving the Nonsmoking Self Can Induce Lower Discounting and Cigarette Consumption. J Stud Alcohol Drugs. 2017 Jan;78(1):106-112. doi: 10.15288/jsad.2017.78.106.

    PMID: 27936370BACKGROUND

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Michael D Baker, Ph.D.

    East Carolina University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael D Baker, Ph.D.

CONTACT

Erik Everhart, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blind to the hypothesis of the study and to the condition to which they are assigned. They will be informed of both of these details during a debriefing provided by the researcher upon the conclusion of data collection.
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Model Details: Stage 1 will employ a between-subjects experimental design to establish the effectiveness of the mating-EFT intervention and compare its effectiveness to that of the established general-EFT intervention (Chiou \& Wu, 2017) and a yoked control condition. This study will determine whether the effectiveness of these interventions is moderated by individual differences in relationship status, fundamental social motives (including mate-seeking motivation), self-efficacy, and nicotine dependence. Stage 2 will employ a quasi-experimental design in which participants who are either currently involved in a committed romantic relationship or single will be randomly assigned to complete either a mating-centric EFT intervention, a general-EFT intervention, or a control activity that involves no intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 13, 2018

Study Start

January 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 14, 2018

Record last verified: 2018-02