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

• Sponsor: University of Arizona (Other)
• Overall Status: Completed
• CT.gov ID: NCT02968381
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH), West Virginia University (Other)
• Enrollment: 121
• Location: 1
• Arms: 2
• Actual Duration (Months): 44.7
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

Tobacco use is still the leading cause of preventable disease and death in the United States. Tobacco quit lines are effective at helping smokers to quit, but quit lines are underutilized, especially by men and racial/ethnic minorities. Guided imagery is effective at helping people quit smoking, and is appealing to males and diverse racial groups, but has limited reach. The proposed study will develop and test the feasibility and acceptability of a guided imagery tobacco cessation intervention that is delivered by a combination of quit line coaches and an interactive website. The investigators hypothesize that guided mental imagery delivered using the quit line "coaching model" combined with an interactive website could be an effective intervention strategy.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use; Smoking Cessation; Smoking, Tobacco; Tobacco Smoking; Guided Imagery	Behavioral: Imagery Intervention; Behavioral: Control Condition	N/A

Detailed Description

The objective of this three year R34 application is to develop and test the feasibility of a theory-driven, telephone plus web-based, guided mental imagery intervention for smoking cessation.

Aim 1. Develop a theory-based, guided mental imagery tobacco cessation intervention for quit line callers with input from expert consultants in health disparities and a Community Advisory Board representing diverse populations and tobacco control stakeholders. The intervention will include phone-based coaching, an interactive website, and optional cessation medication. It will be focus tested with 40 smokers (from diverse racial/ethnic and age groups with at least 40% males), and usability tested with 5 smokers.

Aim 2. Develop training and competency standards for, and train, four coaches in the implementation of the guided imagery and control interventions. Coaches will be assessed at 6-weeks and 6-months post-training for implementation fidelity and satisfaction.

Aim 3. Conduct a feasibility trial (N=100) to gather preliminary data on the effects of the guided mental imagery intervention on quit line callers' tobacco use, cravings, and self-efficacy to quit smoking, and to refine study procedures, including recruitment, retention, and use of intervention components. Participants will be randomly assigned to receive either the Imagery Intervention (N=50) or an attention control condition (N=50) as delivered by study coaches. Participants will be assessed at baseline, 6-weeks and 6-months post-enrollment. Primary outcomes will be self-reported point prevalence and prolonged abstinence of tobacco use. Biochemical validation will be conducted on a sub-sample to determine validity of self-reported abstinence in this population. Secondary outcomes will be self-reported cravings and self-efficacy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 121 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Guided Imagery Tobacco Cessation Intervention Delivered by a Quit Line and Website
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: Sep 29, 2020
• Actual Study Completion Date: Jan 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Imagery Intervention; Telephone coaching sessions, use of guided imagery and website.
Active Comparator: 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.	Behavioral: Control Condition; Telephone coaching using standard cognitive behavioral methods; Other Names: Active Comparator

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Change in Self-reported 7-day Tobacco Abstinence From Baseline to Follow-up [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?").

2. Number of Participants With Change in Self-reported Tobacco 30-day Abstinence From Baseline to Follow-up [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?").

Secondary Outcome Measures

1. Change in Tobacco Use for Non-quitters From Baseline to Follow-up [6 months]

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

2. Change in Self-efficacy for Quitting From Baseline to Follow-up [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).

3. Change in Nicotine Cravings From Baseline to Follow-up [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Current smoker trying to quit

• Speak English

• Internet access

• Email access

• Live in the state of Arizona, USA

Exclusion Criteria:

• Having enrolled and participated in Quit line services in the past 12 months

• Diagnosed with a serious mental illness (e.g. current depression)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States	85721

Sponsors and Collaborators

• University of Arizona
• National Center for Complementary and Integrative Health (NCCIH)
• West Virginia University

Investigators

• Principal Investigator: Judith Gordon, PhD, University of Arizona

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 6, 2018

More Information

Additional Information:

• Pilot project using guided imagery for tobacco cessation for women concerned about weight gain

Publications

None provided.

• Responsible Party: University of Arizona
• ClinicalTrials.gov Identifier: NCT02968381
• Other Study ID Numbers: 1R34AT008947; 1R34AT008947
• First Posted: Nov 18, 2016
• Last Update Posted: Jun 22, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Arizona: tobacco; smoking; imagery

Study Results

Participant Flow

Arm/Group Title	Imagery Intervention	Control Condition
Arm/Group Description	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.	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
Period Title: Overall Study
STARTED	61	60
COMPLETED	56	50
NOT COMPLETED	5	10

Baseline Characteristics

Arm/Group Title	Imagery Intervention	Control Condition	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	56	49	105
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	56 100%	48 98%	104 99%
>=65 years	0 0%	1 2%	1 1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.5 (15.8)	51.6 (14.5)	50.5 (14.4)
Sex: Female, Male (Count of Participants)
Female	36 64.3%	33 67.3%	69 65.7%
Male	20 35.7%	16 32.7%	36 34.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 14.3%	9 18.4%	17 16.2%
Not Hispanic or Latino	48 85.7%	40 81.6%	88 83.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 3.6%	1 2%	3 2.9%
Asian	1 1.8%	1 2%	2 1.9%
Native Hawaiian or Other Pacific Islander	0 0%	1 2%	1 1%
Black or African American	2 3.6%	2 4.1%	4 3.8%
White	45 80.4%	39 79.6%	84 80%
More than one race	3 5.4%	3 6.1%	6 5.7%
Unknown or Not Reported	3 5.4%	2 4.1%	5 4.8%
Region of Enrollment (participants) [Number]
United States	56 100%	49 100%	105 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Change in Self-reported 7-day Tobacco Abstinence From Baseline to Follow-up
Description	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?").
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Imagery Intervention	Control Condition
Arm/Group Description	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.	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
Measure Participants	56	49
Count of Participants [Participants]	15 26.8%	21 42.9%

2. Primary Outcome

Title	Number of Participants With Change in Self-reported Tobacco 30-day Abstinence From Baseline to Follow-up
Description	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?").
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Imagery Intervention	Control Condition
Arm/Group Description	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.	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
Measure Participants	56	49
Count of Participants [Participants]	12 21.4%	16 32.7%

3. Secondary Outcome

Title	Change in Tobacco Use for Non-quitters From Baseline to Follow-up
Description	Assessed by project staff at 6-months post-enrollment.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Imagery Intervention	Control Condition
Arm/Group Description	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.	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
Measure Participants	56	49
Mean (Standard Deviation) [Cigarettes]	9.1 (6.1)	11.2 (9.0)

4. Secondary Outcome

Title	Change in Self-efficacy for Quitting From Baseline to Follow-up
Description	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).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Imagery Intervention	Control Condition
Arm/Group Description	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.	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
Measure Participants	56	49
Mean (Standard Deviation) [units on a scale]	4.1 (1.1)	4.0 (1.2)

5. Secondary Outcome

Title	Change in Nicotine Cravings From Baseline to Follow-up
Description	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).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Imagery Intervention	Control Condition
Arm/Group Description	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.	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
Measure Participants	56	49
Mean (Standard Deviation) [score on a scale]	2.1 (1.2)	2.2 (1.7)

Adverse Events

Time Frame	10 months
Adverse Event Reporting Description	The intervention and control conditions were both cognitive behavioral and posed no risk to participants.
Arm/Group Title	Imagery Intervention		Control Condition
Arm/Group Description	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.		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
All Cause Mortality
	Imagery Intervention		Control Condition
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/49 (0%)
Serious Adverse Events
	Imagery Intervention		Control Condition
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/49 (0%)
Other (Not Including Serious) Adverse Events
	Imagery Intervention		Control Condition
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/49 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.