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

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.

Study Overview

• Status: Unknown
• Conditions: Smoking; Smoking Cessation; Smoking, Tobacco
• Intervention / Treatment: Behavioral: Self affirmation, 10 items, no examples; Behavioral: Self affirmation, 10 items, written examples; Behavioral: Self affirmation, 10 items, imagined examples; Behavioral: Self affirmation, 5 items, no examples; Behavioral: Self affirmation, 3 items, no examples; Behavioral: Self affirmation, 5 items, written examples; Behavioral: Self affirmation, 3 items, written examples; Behavioral: Self affirmation, 5 items, imagined examples; Behavioral: Self affirmation, 3 items, imagined examples

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 900
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Kent, Ohio, United States, 44242
      • Kent State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

15

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-affirm, No examples, Study 1; Behavioral: Self affirmation, 10 items, no examples	Behavioral: 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.
Active Comparator: Self-affirm, Write examples, Study 1; Behavioral: Self affirmation, 10 items, written examples	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.
Experimental: Self-affirm, Imagine examples, Study 1; Behavioral: Self affirmation, 10 items, imagined examples	Behavioral: 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.
No Intervention: Opinion survey, No examples, Study 1; No intervention: control. Participants will complete the 10 item personal opinion survey and will not be asked to provide examples for any items they respond "yes" to.
No Intervention: Opinion survey, Write examples, Study 1; No intervention: control. Participants will complete the 10 item personal opinion survey and will be asked to provide written examples for each item they respond "yes" to.
No Intervention: Opinion survey, Imagine examples, Study1; No intervention: control. Participants will complete the 10 item personal opinion survey and will be asked to imagine examples for each item they respond "yes" to.
Experimental: Self-affirm, 10-item, No ex, Study 2; Behavioral: Self affirmation, 10 items, no examples	Behavioral: 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.
Experimental: Self-affirm, 5-item, No ex, Study 2; Behavioral: Self affirmation, 5 items, no examples	Behavioral: 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.
Experimental: Self-affirm, 3-item, No ex, Study 2; Behavioral: Self affirmation, 3 items, no examples	Behavioral: 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.
Active Comparator: Self-affirm, 10-item, Write ex, Study 2; Behavioral: Self affirmation, 10 items, written examples	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.
Experimental: Self-affirm, 5-item, Write ex, Study 2; Behavioral: Self affirmation, 5 items, written examples	Behavioral: 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.
Experimental: Self-affirm, 3-item, Write ex, Study 2; Behavioral: Self affirmation, 3 items, written examples	Behavioral: 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.
Experimental: Self-affirm, 10-item, Imagine ex, Study2; Behavioral: Self affirmation, 10 items, imagined examples	Behavioral: 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.
Experimental: Self-affirm, 5-item, Imagine ex, Study 2; Behavioral: Self affirmation, 5 items, imagined examples	Behavioral: 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.
Experimental: Self-affirm, 3-item, Imagine ex, Study 2; Behavioral: Self affirmation, 3 items, imagined examples	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defensive Avoidance	Indicator of defensive information processing, 3 items (Witte)	immediately post-intervention
Reactance	Indicator of defensive information processing, 27 items (Hall et al., 2016)	immediately post-intervention
Yielding	Indicator of defensive information processing, 7 items (Brennan et al., 2011, 2014)	immediately post-intervention
Intentions to quit smoking in the next 3 months	Intentions to quit smoking, 3 items	immediately post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive perceived likelihood of developing smoking related disease	3 items	immediately post-intervention
Perceived severity	3 items	immediately post-intervention
Response efficacy of quitting smoking	3 items	immediately post-intervention
Self-efficacy to quit smoking	3 items	immediately post-intervention
Affective perceived likelihood	3 items	immediately post-intervention
Anticipated regret	3 items	immediately post-intervention
Worry	3 items	immediately post-intervention

Collaborators and Investigators

• Sponsor: Kent State University
• Collaborators: Washington University School of Medicine
• Investigators: Principal Investigator: Jennifer M Taber, PhD, Kent State University

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2018
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: smoking; cessation; mobile application; self-affirmation
• Other Study ID Numbers: 17-544

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Individual participant data will be made available to other researchers upon request following publication of the results of the study. Alternatively, data may be posted on a site such as Open Science Framework and made publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No