- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02968381
A Guided Imagery Tobacco Cessation Intervention Delivered by a Quit Line and Website (QLImagery)
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85721
- University of Arizona
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
|
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.
|
Telephone coaching using standard cognitive behavioral methods
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Change in Self-reported 7-day Tobacco Abstinence From Baseline to Follow-up
Time Frame: 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?").
|
6 months
|
Number of Participants With Change in Self-reported Tobacco 30-day Abstinence From Baseline to Follow-up
Time Frame: 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?").
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Tobacco Use for Non-quitters From Baseline to Follow-up
Time Frame: 6 months
|
Assessed by project staff at 6-months post-enrollment.
|
6 months
|
Change in Self-efficacy for Quitting From Baseline to Follow-up
Time Frame: 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).
|
6 months
|
Change in Nicotine Cravings From Baseline to Follow-up
Time Frame: 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).
|
6 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
-
University of VermontMayo Clinic; Alaska Native Tribal Health ConsortiumTerminatedSmoking | Smoking CessationUnited States
-
University of Wisconsin, MadisonCentiment LLCCompletedSmoking | Smoking CessationUnited States
-
Yale UniversityCompletedSmoking | Smoking CessationUnited States
-
Johns Hopkins UniversityMaryland Department of Health and Mental HygieneCompletedCOach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation (C2Q)Smoking | Smoking CessationUnited States
Clinical Trials on Imagery Intervention
-
Hella JanssenCompletedPsychosis | Auditory Hallucination | Hearing Voices When No One is TalkingNetherlands
-
Seton Hall UniversityUnknown
-
Seton Hall UniversityNot yet recruiting
-
St. Justine's HospitalCompleted
-
Universidad Autonoma de MadridCentro Universitario La SalleUnknown
-
Albert Einstein College of MedicineCompletedMotor ActivityUnited States
-
Universidad Autonoma de MadridCentro Universitario La SalleUnknown
-
University of SurreyCompletedCompassion | Perfectionism | Resilience | Rumination | Self-CriticismUnited Kingdom
-
University of ArizonaNational Center for Complementary and Integrative Health (NCCIH)RecruitingSmoking | Smoking Cessation | Smoking Reduction | Smoking, Cigarette | Smoking Habit | Smoking (Tobacco) AddictionUnited States
-
I.R.C.C.S. Fondazione Santa LuciaUniversity of Roma La Sapienza; Istituto Superiore di SanitàCompleted