Guided Imagery, Smoking Cessation, Smoking, Tobacco, Tobacco Smoking, Tobacco Use
Conditions
Keywords
tobacco, smoking, imagery
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.
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.
Interventions
BEHAVIORALImagery Intervention
Telephone coaching sessions, use of guided imagery and website.
BEHAVIORALControl Condition
Telephone coaching using standard cognitive behavioral methods
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
West Virginia University
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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?). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Tobacco Use for Non-quitters From Baseline to Follow-up | 6 months | Assessed by project staff at 6-months post-enrollment. |
| 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). |
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 56 |
| 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 | 49 |
| Total | 105 |
Baseline characteristics
| Characteristic | Imagery Intervention | Control Condition | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants | 48 Participants | 104 Participants |
| Age, Continuous | 48.5 years STANDARD_DEVIATION 15.8 | 51.6 years STANDARD_DEVIATION 14.5 | 50.5 years STANDARD_DEVIATION 14.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 9 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 40 Participants | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 45 Participants | 39 Participants | 84 Participants |
| Region of Enrollment United States | 56 participants | 49 participants | 105 participants |
| Sex: Female, Male Female | 36 Participants | 33 Participants | 69 Participants |
| Sex: Female, Male Male | 20 Participants | 16 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 49 |
| other Total, other adverse events | 0 / 56 | 0 / 49 |
| serious Total, serious adverse events | 0 / 56 | 0 / 49 |
Outcome results
Primary
Number of Participants With Change in Self-reported 7-day Tobacco Abstinence From Baseline to Follow-up
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Imagery Intervention | Number of Participants With Change in Self-reported 7-day Tobacco Abstinence From Baseline to Follow-up | 15 Participants |
| Control Condition | Number of Participants With Change in Self-reported 7-day Tobacco Abstinence From Baseline to Follow-up | 21 Participants |
Primary
Number of Participants With Change in Self-reported Tobacco 30-day Abstinence From Baseline to Follow-up
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Imagery Intervention | Number of Participants With Change in Self-reported Tobacco 30-day Abstinence From Baseline to Follow-up | 12 Participants |
| Control Condition | Number of Participants With Change in Self-reported Tobacco 30-day Abstinence From Baseline to Follow-up | 16 Participants |
Secondary
Change in Nicotine Cravings From Baseline to Follow-up
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagery Intervention | Change in Nicotine Cravings From Baseline to Follow-up | 2.1 score on a scale | Standard Deviation 1.2 |
| Control Condition | Change in Nicotine Cravings From Baseline to Follow-up | 2.2 score on a scale | Standard Deviation 1.7 |
Secondary
Change in Self-efficacy for Quitting From Baseline to Follow-up
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagery Intervention | Change in Self-efficacy for Quitting From Baseline to Follow-up | 4.1 units on a scale | Standard Deviation 1.1 |
| Control Condition | Change in Self-efficacy for Quitting From Baseline to Follow-up | 4.0 units on a scale | Standard Deviation 1.2 |
Secondary
Change in Tobacco Use for Non-quitters From Baseline to Follow-up
Assessed by project staff at 6-months post-enrollment.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagery Intervention | Change in Tobacco Use for Non-quitters From Baseline to Follow-up | 9.1 Cigarettes | Standard Deviation 6.1 |
| Control Condition | Change in Tobacco Use for Non-quitters From Baseline to Follow-up | 11.2 Cigarettes | Standard Deviation 9 |