Testing a Self-affirmation Intervention for Use in a Mobile Application

Smoking Cessation Clinical Trial

Official title:

Testing a Self-affirmation Intervention for Use in a Mobile Application

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03405220
• Other study ID #: 17-544
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 16, 2018
• Est. completion date: September 2018

Study information

• Verified date: May 2018
• Source: Kent State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of these studies is to adapt the self-affirmation kindness questionnaire for use in a mobile application. Two studies will be conducted to test hypotheses that simplifying and shortening the original questionnaire in systematic ways will result in comparable effectiveness (compared to the original version) in promoting reduced defensive avoidance, less reactance, greater yielding, and higher intentions to quit smoking among a sample of smokers.

Description:

Research has shown that self-affirmation interventions, in which people are instructed to focus on their strengths and values, can offset self-threats and promote healthier behaviors, such as smoking cessation. A commonly used self-affirmation intervention is known as the "kindness quiz." The original kindness questionnaire (Reed & Aspinwall, 1998) consists of 10 yes/no questions, and participants are asked to think about and write down an example of each. For example, one item is "Have you ever been considerate of another person's feelings? ____ YES ____NO; IF YES, WRITE ABOUT A SPECIFIC EXAMPLE." The items were written so that all participants should be able to say "yes" in response to each question, which will affirm a positive view of themselves.

The purpose of these studies are to test shorter and simpler versions of this kindness questionnaire so that it can be implemented on mobile phones. In Study 1, we will test whether written examples are necessary for the effectiveness of the self-affirmation intervention (compared to no examples or imagined examples) compared to a control. In Study 2, we will again test whether written examples are necessary, as well as whether shorter questionnaires (i.e., 5 items or 3 items) are as effective as the original 10 item questionnaire.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 900
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Currently live in the US

• 21-65 years (several states have 21 as minimum legal age to smoke)

• self-identified every day or some day smoker

• no prior diagnosis of lung cancer, chronic obstructive pulmonary disease, or emphysema (the most common and well-known smoking-related diseases

Exclusion Criteria:

• Not currently living in the US

• Less than 21 years of age or older than 65

• Nonsmoker

• Prior diagnosis of lung cancer, chronic obstructive pulmonary disease, or emphysema (the most common and well-known smoking-related diseases

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation
• Smoking, Tobacco

Intervention

Behavioral:
• Self affirmation, 10 items, written examples
Participants will complete the 10 item self-affirmation kindness quiz and will be asked to provide written examples for each item they respond "yes" to.
• Self affirmation, 10 items, no examples
Participants will complete the 10 item self-affirmation kindness quiz and will not be asked to provide examples for any items they respond "yes" to.
• Self affirmation, 10 items, imagined examples
Participants will complete the 10 item self-affirmation kindness quiz and will be asked to imagine examples for each item they respond "yes" to.
• Self affirmation, 5 items, written examples
Participants will complete a 5 item self-affirmation kindness quiz and will be asked to provide written examples for each item they respond "yes" to.
• Self affirmation, 5 items, no examples
Participants will complete a 5 item self-affirmation kindness quiz and will not be asked to provide examples for any items they respond "yes" to.
• Self affirmation, 5 items, imagined examples
Participants will complete a 5 item self-affirmation kindness quiz and will be asked to imagine examples for each item they respond "yes" to.
• Self affirmation, 3 items, written examples
Participants will complete a 3 item self-affirmation kindness quiz and will be asked to provide written examples for each item they respond "yes" to.
• Self affirmation, 3 items, no examples
Participants will complete a 3 item self-affirmation kindness quiz and will not be asked to provide examples for any items they respond "yes" to.
• Self affirmation, 3 items, imagined examples
Participants will complete a 3 item self-affirmation kindness quiz and will be asked to imagine examples for each item they respond "yes" to.

Locations

Country	Name	City	State
United States	Kent State University	Kent	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Kent State University	Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Reed, M. B., & Aspinwall, L. G. (1998). Self-affirmation reduces biased processing of health-risk information. Motivation and Emotion, 22(2), 99-132.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Defensive Avoidance	Indicator of defensive information processing, 3 items (Witte)	immediately post-intervention
Primary	Reactance	Indicator of defensive information processing, 27 items (Hall et al., 2016)	immediately post-intervention
Primary	Yielding	Indicator of defensive information processing, 7 items (Brennan et al., 2011, 2014)	immediately post-intervention
Primary	Intentions to quit smoking in the next 3 months	Intentions to quit smoking, 3 items	immediately post-intervention
Secondary	Cognitive perceived likelihood of developing smoking related disease	3 items	immediately post-intervention
Secondary	Perceived severity	3 items	immediately post-intervention
Secondary	Response efficacy of quitting smoking	3 items	immediately post-intervention
Secondary	Self-efficacy to quit smoking	3 items	immediately post-intervention
Secondary	Affective perceived likelihood	3 items	immediately post-intervention
Secondary	Anticipated regret	3 items	immediately post-intervention
Secondary	Worry	3 items	immediately post-intervention