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

• ClinicalTrials.gov Identifier: NCT03405220
• Recruitment Status: Unknown
• First Posted: January 23, 2018
• Last Update Posted: May 21, 2018
• Sponsor: Kent State University
• Collaborator: Washington University School of Medicine
• Information provided by (Responsible Party): Jennifer Taber, Kent State University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Smoking; Smoking Cessation; Smoking, Tobacco	Behavioral: Self affirmation, 10 items, written examples; Behavioral: Self affirmation, 10 items, no examples; Behavioral: Self affirmation, 10 items, imagined examples; Behavioral: Self affirmation, 5 items, written examples; Behavioral: Self affirmation, 5 items, no examples; Behavioral: Self affirmation, 5 items, imagined examples; Behavioral: Self affirmation, 3 items, written examples; Behavioral: Self affirmation, 3 items, no examples; Behavioral: Self affirmation, 3 items, imagined examples	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 900 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment

Intervention Model Description

Study 1 will use a 2 (self-affirmation: self-affirmation, control) X 3 (Mode of example: none, write, imagine) experimental design. In the self-affirmation condition, participants will complete the self-affirmation kindness quiz (10 questions) and in the control condition they will complete a personal opinion survey (10 questions). Depending on the mode of example condition, participants will not be asked to provide examples, asked to write examples for each of the 10 questions, or asked to imagine examples for each of the 10 questions.

Based on examination of data from Study 1 (i.e., which items receive more "yes" responses and for which items examples are provided), in Study 2 we will test whether using fewer self-affirmation items influences dependent variables. Study 2 will use a 3 (Number of questions: 10, 5, 3) X 3 (Mode of example: none, write, imagine) experimental design.

• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Testing a Self-affirmation Intervention for Use in a Mobile Application
• Actual Study Start Date: January 16, 2018
• Estimated Primary Completion Date: September 2018
• Estimated Study Completion Date: September 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Cognitive perceived likelihood of developing smoking related disease [ Time Frame: immediately post-intervention ]
   3 items
2. Perceived severity [ Time Frame: immediately post-intervention ]
   3 items
3. Response efficacy of quitting smoking [ Time Frame: immediately post-intervention ]
   3 items
4. Self-efficacy to quit smoking [ Time Frame: immediately post-intervention ]
   3 items
5. Affective perceived likelihood [ Time Frame: immediately post-intervention ]
   3 items
6. Anticipated regret [ Time Frame: immediately post-intervention ]
   3 items
7. Worry [ Time Frame: immediately post-intervention ]
   3 items

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Ohio

Kent State University

Kent, Ohio, United States, 44242

Sponsors and Collaborators

Kent State University

Washington University School of Medicine

Investigators

• Principal Investigator: Jennifer M Taber, PhD; Kent State University

  Study Documents (Full-Text)

Documents provided by Jennifer Taber, Kent State University:

Informed Consent Form  [PDF] January 1, 2018

More Information

Publications:

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

• Responsible Party: Jennifer Taber, Assistant Professor, Kent State University
• ClinicalTrials.gov Identifier: NCT03405220
• Other Study ID Numbers: 17-544
• First Posted: January 23, 2018
• Last Update Posted: May 21, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jennifer Taber, Kent State University:

smoking; self-affirmation; mobile application; cessation