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Trial Outcomes & Findings for A Guided Imagery Tobacco Cessation Intervention Delivered by a Quit Line and Website (NCT NCT02968381)

NCT ID: NCT02968381

Last Updated: 2022-06-22

Results Overview

Tobacco use over the past seven days is assessed by project staff at 6-months post-enrollment. Tobacco use includes cigarettes, smokeless tobacco, and other types of tobacco. The question is asked "Have you smoked, even a puff, in the last 7 days?" "Have you used any other form of tobacco in the last 7 days?" If yes to either question, the participant is asked to indicate what type of tobacco was used and how much was used (e.g., "how many cigarettes did you smoke on a typical day?").

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

121 participants

Primary outcome timeframe

6 months

Results posted on

2022-06-22

Participant Flow

Participant milestones

Participant milestones
Measure
Imagery Intervention
Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website. Imagery Intervention: Telephone coaching sessions, use of guided imagery and website.
Control Condition
Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website. Control Condition: Telephone coaching using standard cognitive behavioral methods
Overall Study
STARTED
61
60
Overall Study
COMPLETED
56
50
Overall Study
NOT COMPLETED
5
10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Guided Imagery Tobacco Cessation Intervention Delivered by a Quit Line and Website

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Imagery Intervention
n=56 Participants
Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website. Imagery Intervention: Telephone coaching sessions, use of guided imagery and website.
Control Condition
n=49 Participants
Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website. Control Condition: Telephone coaching using standard cognitive behavioral methods
Total
n=105 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
56 Participants
n=5 Participants
48 Participants
n=7 Participants
104 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Age, Continuous
48.5 years
STANDARD_DEVIATION 15.8 • n=5 Participants
51.6 years
STANDARD_DEVIATION 14.5 • n=7 Participants
50.5 years
STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male
Female
36 Participants
n=5 Participants
33 Participants
n=7 Participants
69 Participants
n=5 Participants
Sex: Female, Male
Male
20 Participants
n=5 Participants
16 Participants
n=7 Participants
36 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants
n=5 Participants
9 Participants
n=7 Participants
17 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
48 Participants
n=5 Participants
40 Participants
n=7 Participants
88 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
White
45 Participants
n=5 Participants
39 Participants
n=7 Participants
84 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
3 Participants
n=5 Participants
3 Participants
n=7 Participants
6 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Region of Enrollment
United States
56 participants
n=5 Participants
49 participants
n=7 Participants
105 participants
n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Tobacco use over the past seven days is assessed by project staff at 6-months post-enrollment. Tobacco use includes cigarettes, smokeless tobacco, and other types of tobacco. The question is asked "Have you smoked, even a puff, in the last 7 days?" "Have you used any other form of tobacco in the last 7 days?" If yes to either question, the participant is asked to indicate what type of tobacco was used and how much was used (e.g., "how many cigarettes did you smoke on a typical day?").

Outcome measures

Outcome measures
Measure
Imagery Intervention
n=56 Participants
Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website. Imagery Intervention: Telephone coaching sessions, use of guided imagery and website.
Control Condition
n=49 Participants
Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website. Control Condition: Telephone coaching using standard cognitive behavioral methods
Number of Participants With Change in Self-reported 7-day Tobacco Abstinence From Baseline to Follow-up
15 Participants
21 Participants

PRIMARY outcome

Timeframe: 6 months

Tobacco use over the past 30 days is assessed by project staff at 6-months post-enrollment. Tobacco use includes cigarettes, smokeless tobacco, and other types of tobacco. The question is asked "Have you smoked, even a puff, in the last 30 days?" "Have you used any other form of tobacco in the last 30 days?" If yes to either question, the participant is asked to indicate what type of tobacco was used and how much was used (e.g., "how many cigarettes did you smoke on a typical day?").

Outcome measures

Outcome measures
Measure
Imagery Intervention
n=56 Participants
Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website. Imagery Intervention: Telephone coaching sessions, use of guided imagery and website.
Control Condition
n=49 Participants
Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website. Control Condition: Telephone coaching using standard cognitive behavioral methods
Number of Participants With Change in Self-reported Tobacco 30-day Abstinence From Baseline to Follow-up
12 Participants
16 Participants

SECONDARY outcome

Timeframe: 6 months

Assessed by project staff at 6-months post-enrollment.

Outcome measures

Outcome measures
Measure
Imagery Intervention
n=56 Participants
Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website. Imagery Intervention: Telephone coaching sessions, use of guided imagery and website.
Control Condition
n=49 Participants
Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website. Control Condition: Telephone coaching using standard cognitive behavioral methods
Change in Tobacco Use for Non-quitters From Baseline to Follow-up
9.1 Cigarettes
Standard Deviation 6.1
11.2 Cigarettes
Standard Deviation 9.0

SECONDARY outcome

Timeframe: 6 months

An abbreviated version of the Condiotte and Lichtenstein (1981) Confidence Questionnaire consisting of 5 items for quitters and 6 items for non-quitters. All items are scored using a 5-point Likert scale where 1 is low/less and 5 is high/more. We calculated an average score of the items (which would have a value between 1 and 5).

Outcome measures

Outcome measures
Measure
Imagery Intervention
n=56 Participants
Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website. Imagery Intervention: Telephone coaching sessions, use of guided imagery and website.
Control Condition
n=49 Participants
Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website. Control Condition: Telephone coaching using standard cognitive behavioral methods
Change in Self-efficacy for Quitting From Baseline to Follow-up
4.1 units on a scale
Standard Deviation 1.1
4.0 units on a scale
Standard Deviation 1.2

SECONDARY outcome

Timeframe: 6 months

This was assessed using 1 item adapted from the Shiffman (2004) Rating Scale ("How much have you craved tobacco today?"). Responses were coded using a 6-point Likert scale from "not at all" (code 0) to "a great deal" (code 5).

Outcome measures

Outcome measures
Measure
Imagery Intervention
n=56 Participants
Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website. Imagery Intervention: Telephone coaching sessions, use of guided imagery and website.
Control Condition
n=49 Participants
Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website. Control Condition: Telephone coaching using standard cognitive behavioral methods
Change in Nicotine Cravings From Baseline to Follow-up
2.1 score on a scale
Standard Deviation 1.2
2.2 score on a scale
Standard Deviation 1.7

Adverse Events

Imagery Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Condition

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Judith Gordon

University of Arizona

Phone: 520-626-4970

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place