NCT02522156

Brief Summary

Almost one-fifth of US adults are current cigarette smokers. To make further progress in lowering prevalence, it would help to increase the proportion of smokers attempting to quit. This application tests a novel approach to motivating smokers to quit, based on an empirically supported theory of anxiety. The approach uses guided imagery to increase smokers' sense of urgency about preventing the negative health consequences of smoking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
279

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

3.4 years

First QC Date

August 10, 2015

Last Update Submit

January 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quit attempt

    yes/no, whether or not the participant made a 24-hour (or longer) quit attempt between the date of the main experiment and the date of the 4-week follow-up assessment.

    4-week follow-up

Secondary Outcomes (5)

  • Abstinence

    4-week follow-up

  • Smoking rate

    4-week follow-up

  • Contemplation of quitting

    4-week follow-up

  • self-efficacy (Smoking Self-Efficacy Questionnaire; SSEQ)

    4-week follow-up

  • outcome expectancies (Smoking Consequences Questionnaire-Adult; SCQ-A)

    4-week follow-up

Study Arms (2)

Looming Vulnerability Induction

EXPERIMENTAL

Four audiotape-guided imagery exercises, each lasting about 3 minutes: * Conveyor Belt: Places the participants in a dimly-lit factory, in which they are being carried along faster and faster on a conveyor belt as they smoke. This conveyor belt is described as ultimately leading to the diagnosis of lung cancer. * Office Building: Places participants in an office all alone, watching calendar pages fly off the wall. As participants smoke and time progresses, participants are meant to feel their lungs withering away and their heart beat becoming weaker and weaker. * Train Tracks: Set in the open plains on top of a set of railroad tracks. As participants smoke, a train heading directly towards them gains speed. * Clock Ticking: In this timing exercise, participants are instructed to imagine terrible health consequences related to smoking coming closer and closer to them as they smoke. Participants are asked to keep track of time for a period of three minutes.

Behavioral: Looming Vulnerability Induction

Control

PLACEBO COMPARATOR

Four audiotape-guided imagery exercises, as follows: * Escalator (parallel to "conveyor belt" above): Takes place in an empty mall in the morning. The participants imagine they are slowly and steadily being carried by the escalator until they reach the top. * Metro (parallel to "office building"): Involves riding public transportation while reading a magazine, steadily flipping the pages. * Driving (parallel to "Train Tracks"): Involves driving a car. The car in this case moves steadily with no traffic hindrances that would cause a reduction of speed. * Human Clock (parallel to "Clock Ticking"): Another timing exercise. In this case, the participants receive instruction to pretend they are a human clock.

Behavioral: Control

Interventions

guided imagery aimed at inducing smoking cessation attempts. See description of the looming vulnerability arm.

Looming Vulnerability Induction
ControlBEHAVIORAL

Neutral guided imagery scenarios making no reference to smoking.

Control

Eligibility Criteria

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

You may qualify if:

  • Adults (age 18 or older).
  • Daily cigarette smokers (at least 10 cigarettes per day).
  • Fluent in English. -

You may not qualify if:

  • planning to leave the Washington, DC area in the next month.
  • Total score \> 5 on the Modified Mini Screen measure of risk for anxiety or mood disorders
  • Score \> 0 on the suicidality item (#4) of Modified Mini Screen -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University

Washington D.C., District of Columbia, 20016-8062, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 13, 2015

Study Start

February 1, 2016

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

January 29, 2020

Record last verified: 2020-01

Locations