- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03431324
Mating-EFT Smoking Cessation Intervention
Employing Episodic Future Thinking About Mating Opportunities to Induce Lower Cigarette Consumption
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tobacco use is one of the leading causes of preventable illness and premature death worldwide. Individuals who smoke tobacco tend to develop a physical addiction to nicotine. Behavioral interventions have been shown to be an effective means of assisting with smoking cessation. Smoking cessation interventions, especially those of a brief and intensive nature, have been shown to be a cost-effective means of preventing negative health outcomes and extending life expectancy.
The PRIME theory of motivation regards cigarette addiction as a disorder of motivation. Accordingly, this theory seeks to help practitioners to identify effective means of overcoming addition through an analysis of the plans, responses, motives, impulses, and evaluations of smokers. Behavioral interventions often employ motivation interviewing with the goal of enhancing the motivation of smokers to quit by increasing their enthusiasm for positive life outcomes associated with quitting as well as giving a sense of purpose to this behavioral change.
Evolutionary perspectives on human behavior suggest that the desire to find a mate is a fundamental social motive that drives much of human behavior. Accordingly, encouraging smokers to think about how quitting could be beneficial to their mating goals could be an effective means of enhancing motivation to quit. A brief intervention that requires smokers to employ episodic future thinking (EFT) has been shown to effectively reduce smoking behavior. The current proposal aims to (1) develop and test the effectiveness of a behavioral intervention that employs EFT about how immediate quitting of smoking could enhance prospects for mating success and (2) refine this intervention by identifying key individual differences that impact its effectiveness, in order to maximize successful cessation outcomes by targeting populations that would be more strongly motivated by mating-related goals.
Aim 1: To develop and test the effectiveness of a behavioral smoking cessation intervention that employs EFT about future mating opportunities. EFT involves thinking about oneself experiencing a specific future event. Research indicates that this type of thinking reduces the tendency for people to discount the future costs associated with current behaviors and to reduce cigarette consumption. Since mating goals are of fundamental importance to human social life, an intervention that involves EFT about how quitting smoking could lead to increased likelihood of success in a specific future mating situation may be an especially effective means of motivating smokers to quit. Specifically, smokers will be instructed to imagine how quitting today could improve their chances of attracting a mate in a specific future mating situation.
Aim 2: To determine whether individual differences in mating motives moderate the effectiveness of the proposed intervention. People who are involved in a committed romantic relationship are often less motivated to seek a new mate than people who are single. Furthermore, some people are generally more motivated to seek new mates than others, regardless of relationship status. Self-report measures are commonly used to measure individual differences in preference for sexual variety and motivation to seek new mates. The investigators aim to determine whether relationship status and mating motivation moderate the effectiveness of the proposed mating-EFT smoking cessation intervention. The investigators predict that this intervention would be most effective among individuals who are not currently involved in a committed romantic relationship and are highly motivated to seek new mates.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age 18 or older
- Fluent in English
Current smoker
- Motivated to quit or reduce their cigarette consumption
Exclusion Criteria:
- Under 18 years of age
- Not fluent in English
Not currently a smoker
- Not motivated to quit or reduce cigarette consumption
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Mating-EFT Intervention Effectiveness
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. |
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". |
|
Experimental: Message Tailoring for Smoking Cessation
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cigarette Consumption
Periodo de tiempo: 7 days
|
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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Motivation to Quit or Reduce Smoking
Periodo de tiempo: 7 days
|
Participants will also report their level of motivation to quit smoking or reduce their cigarette consumption as well as how motivated they are by different positive life outcomes that could result from quitting.
This measurement will serve as both a manipulation check (with participants in the mating-EFT condition expected to report that they are more motivated by mating-related benefits of smoking cessation compared to the other conditions) as well as a secondary dependent variable that will also allow us to determine whether motivation is a mechanism influencing smoking cessation efforts.
|
7 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michael D Baker, Ph.D., East Carolina University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 18-0509
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .