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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01923467
Other study ID # P50CA101451
Secondary ID
Status Completed
Phase N/A
First received August 13, 2013
Last updated May 29, 2015
Start date August 2013
Est. completion date April 2014

Study information

Verified date December 2014
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This project is designed to test the effects of affirmation and positive/negative imagery on individuals' thoughts about quitting smoking and willingness to join a stop smoking program. Previous studies have noted that viewing negative images elicits a stronger emotional response, and many stop-smoking campaigns have used such images to push people to quit smoking. However, research also shows that people are generally resistant to health messages. Using affirmation can help to lessen that resistance.

In this study, we use a 2x3 design to study the individual effects of negative imagery and affirmation on smokers' intentions to quit smoking, acceptance of an offer to join a quit smoking program, and program participation and outcomes. We hope to find out whether there is an additive effect of the negative imagery and affirmation on the outcomes listed above. Our specific aims are:

Aim 1: Determine if affirmation increases the uptake of an offer of joining a stop smoking program.

Aim 2: Determine if image type (positive vs. neutral vs. negative) increases the uptake of the stop smoking program offer.

Aim 3: Determine whether there is an interaction between image type and affirmation in people's willingness to join a stop smoking program.


Recruitment information / eligibility

Status Completed
Enrollment 767
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Current smoker

Exclusion Criteria:

- Current participation in another stop-smoking program

- Current use of stop smoking medications

- Pregnant or breastfeeding

- Limited internet or email access

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Project Quit stop smoking program
This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.
Drug:
Nicotine patches 21 mg
Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt.

Locations

Country Name City State
United States Center for Health Communications Research, University of Michigan Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptance of Offer to Join Stop Smoking Program After participation in online image viewing and writing reflection tasks, participants will be asked if they would like to take part in an online stop-smoking program. 1 Day of Enrollment No
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