NCT02968381

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

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

November 10, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
1.4 years until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2020

Completed
3 months until next milestone

Results Posted

Study results publicly available

January 8, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2022

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

2.4 years

First QC Date

November 10, 2016

Results QC Date

November 10, 2020

Last Update Submit

June 1, 2022

Conditions

Keywords

tobaccosmokingimagery

Outcome Measures

Primary Outcomes (2)

  • 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?").

    6 months

  • 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?").

    6 months

Secondary Outcomes (3)

  • Change in Tobacco Use for Non-quitters From Baseline to Follow-up

    6 months

  • Change in Self-efficacy for Quitting From Baseline to Follow-up

    6 months

  • Change in Nicotine Cravings From Baseline to Follow-up

    6 months

Study Arms (2)

Imagery Intervention

EXPERIMENTAL

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

Control Condition

ACTIVE COMPARATOR

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

Interventions

Telephone coaching sessions, use of guided imagery and website.

Imagery Intervention

Telephone coaching using standard cognitive behavioral methods

Also known as: Active Comparator
Control Condition

Eligibility Criteria

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

You may qualify if:

  • Current smoker trying to quit
  • Speak English
  • Internet access
  • Email access
  • Live in the state of Arizona, USA

You may not qualify if:

  • Having enrolled and participated in Quit line services in the past 12 months
  • Diagnosed with a serious mental illness (e.g. current depression)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

Location

Related Publications (1)

  • Gordon JS, Bell ML, Armin JS, Giacobbi PR, Nair US. A telephone-based guided imagery tobacco cessation intervention: results of a randomized feasibility trial. Transl Behav Med. 2021 Mar 16;11(2):516-529. doi: 10.1093/tbm/ibaa052.

Related Links

MeSH Terms

Conditions

Tobacco UseSmoking CessationTobacco SmokingSmoking

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Results Point of Contact

Title
Judith Gordon
Organization
University of Arizona

Study Officials

  • Judith Gordon, PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 18, 2016

Study Start

May 1, 2018

Primary Completion

September 29, 2020

Study Completion

January 21, 2022

Last Updated

June 22, 2022

Results First Posted

January 8, 2021

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations