Clinical trial NCT03405220: Testing a Self-affirmation Intervention for Use in a Mobile Application
Official title: Testing a Self-affirmation Intervention for Use in a Mobile Application
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking
Smoking Cessation
Smoking, Tobacco
Keywords: smoking
self-affirmation
mobile application
cessation
Lead sponsor: Kent State University
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
First posted: 2018-01-23
Enrollment: 900
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Defensive Avoidance
timeFrame: immediately post-intervention
measure: Reactance
timeFrame: immediately post-intervention
measure: Yielding
timeFrame: immediately post-intervention
measure: Intentions to quit smoking in the next 3 months
timeFrame: immediately post-intervention
Secondary outcomes:
measure: Cognitive perceived likelihood of developing smoking related disease
timeFrame: immediately post-intervention
measure: Perceived severity
timeFrame: immediately post-intervention
measure: Response efficacy of quitting smoking
timeFrame: immediately post-intervention
measure: Self-efficacy to quit smoking
timeFrame: immediately post-intervention
measure: Affective perceived likelihood
timeFrame: immediately post-intervention
measure: Anticipated regret
timeFrame: immediately post-intervention
measure: Worry
timeFrame: immediately post-intervention
Other outcomes:
Locations:
city: Kent
country: United States
facility: Kent State University
state: Ohio
Study officials:
affiliation: Kent State University
name: Jennifer M Taber, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reed, M. B., & Aspinwall, L. G. (1998). Self-affirmation reduces biased processing of health-risk information. Motivation and Emotion, 22(2), 99-132.