SmokingNCT03405220
Testing a Self-affirmation Intervention for Use in a Mobile Application
A study testing Self affirmation, 10 items, written examples, Self affirmation, 10 items, no examples and Self affirmation, 10 items, imagined examples in people with Smoking and Smoking Cessation, run by Kent State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Cessation, Smoking, Tobacco
- What is being tested?
- Self affirmation, 10 items, written examples, Self affirmation, 10 items, no examples and Self affirmation, 10 items, imagined examples
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2018to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Smoking, Smoking Cessation, Smoking, Tobacco
- Being tested
- Self affirmation, 10 items, written examples, Self affirmation, 10 items, no examples, Self affirmation, 10 items, imagined examples, Self affirmation, 5 items, written examples, Self affirmation, 5 items, no examples
- Keywords
- smoking, self-affirmation, mobile application, cessation
- Medical subject headings
- Smoking, Smoking Cessation, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self affirmation, 10 items, written examplesBehavioural
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 examplesBehavioural
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 examplesBehavioural
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 examplesBehavioural
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 examplesBehavioural
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 examplesBehavioural
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 examplesBehavioural
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 examplesBehavioural
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 examplesBehavioural
Participants will complete a 3 item self-affirmation kindness quiz and will be asked to imagine examples for each item they respond "yes" to.
| Study group | Role | What they receive |
|---|---|---|
| Self-affirm, No examples, Study 1 | Experimental | Behavioral: Self affirmation, 10 items, no examples Receives: Behavioral: Self affirmation, 10 items, no examples |
| Self-affirm, Write examples, Study 1 | Active comparator | Behavioral: Self affirmation, 10 items, written examples Receives: Behavioral: Self affirmation, 10 items, written examples |
| Self-affirm, Imagine examples, Study 1 | Experimental | Behavioral: Self affirmation, 10 items, imagined examples Receives: Behavioral: Self affirmation, 10 items, imagined examples |
| Opinion survey, No examples, Study 1 | No intervention | 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. |
| Opinion survey, Write examples, Study 1 | No intervention | 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. |
| Opinion survey, Imagine examples, Study1 | No intervention | 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. |
| Self-affirm, 10-item, No ex, Study 2 | Experimental | Behavioral: Self affirmation, 10 items, no examples Receives: Behavioral: Self affirmation, 10 items, no examples |
| Self-affirm, 5-item, No ex, Study 2 | Experimental | Behavioral: Self affirmation, 5 items, no examples Receives: Behavioral: Self affirmation, 5 items, no examples |
| Self-affirm, 3-item, No ex, Study 2 | Experimental | Behavioral: Self affirmation, 3 items, no examples Receives: Behavioral: Self affirmation, 3 items, no examples |
| Self-affirm, 10-item, Write ex, Study 2 | Active comparator | Behavioral: Self affirmation, 10 items, written examples Receives: Behavioral: Self affirmation, 10 items, written examples |
| Self-affirm, 5-item, Write ex, Study 2 | Experimental | Behavioral: Self affirmation, 5 items, written examples Receives: Behavioral: Self affirmation, 5 items, written examples |
| Self-affirm, 3-item, Write ex, Study 2 | Experimental | Behavioral: Self affirmation, 3 items, written examples Receives: Behavioral: Self affirmation, 3 items, written examples |
| Self-affirm, 10-item, Imagine ex, Study2 | Experimental | Behavioral: Self affirmation, 10 items, imagined examples Receives: Behavioral: Self affirmation, 10 items, imagined examples |
| Self-affirm, 5-item, Imagine ex, Study 2 | Experimental | Behavioral: Self affirmation, 5 items, imagined examples Receives: Behavioral: Self affirmation, 5 items, imagined examples |
| Self-affirm, 3-item, Imagine ex, Study 2 | Experimental | Behavioral: Self affirmation, 3 items, imagined examples Receives: Behavioral: Self affirmation, 3 items, imagined examples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defensive Avoidance
Indicator of defensive information processing, 3 items (Witte)
Measured: immediately post-intervention
Reactance
Indicator of defensive information processing, 27 items (Hall et al., 2016)
Measured: immediately post-intervention
Yielding
Indicator of defensive information processing, 7 items (Brennan et al., 2011, 2014)
Measured: immediately post-intervention
Intentions to quit smoking in the next 3 months
Intentions to quit smoking, 3 items
Measured: immediately post-intervention
Secondary outcomes (7)
Cognitive perceived likelihood of developing smoking related disease
3 items
Measured: immediately post-intervention
Perceived severity
3 items
Measured: immediately post-intervention
Response efficacy of quitting smoking
3 items
Measured: immediately post-intervention
Self-efficacy to quit smoking
3 items
Measured: immediately post-intervention
Affective perceived likelihood
3 items
Measured: immediately post-intervention
Anticipated regret
3 items
Measured: immediately post-intervention
Worry
3 items
Measured: immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start16 Jan 2018
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Principal investigator, Jennifer Taber, Kent State University
- Investigators
- Jennifer M Taber, PhD, Principal investigator, Kent State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405220
- Sponsor's protocol ID
- 17-544
- Status last verified
- May 2018
- First submitted
- 5 Jan 2018
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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 at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Self-affirmation Intervention for Use in a Mobile Application
- ClinicalTrials.gov ID
- NCT03405220
- Acronym / sponsor ID
- 17-544
- Conditions
- Smoking, Smoking Cessation, Smoking, Tobacco
- Keywords
- smoking, self-affirmation, mobile application, cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 15
- 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.
| Arm | Type | Receives |
|---|---|---|
| Self-affirm, No examples, Study 1 | Experimental | Behavioral: Self affirmation, 10 items, no examplesBehavioral: Self affirmation, 10 items, no examples |
| Self-affirm, Write examples, Study 1 | Active comparator | Behavioral: Self affirmation, 10 items, written examplesBehavioral: Self affirmation, 10 items, written examples |
| Self-affirm, Imagine examples, Study 1 | Experimental | Behavioral: Self affirmation, 10 items, imagined examplesBehavioral: Self affirmation, 10 items, imagined examples |
| Opinion survey, No examples, Study 1 | No intervention | –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. |
| Opinion survey, Write examples, Study 1 | No intervention | –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. |
| Opinion survey, Imagine examples, Study1 | No intervention | –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. |
| Self-affirm, 10-item, No ex, Study 2 | Experimental | Behavioral: Self affirmation, 10 items, no examplesBehavioral: Self affirmation, 10 items, no examples |
| Self-affirm, 5-item, No ex, Study 2 | Experimental | Behavioral: Self affirmation, 5 items, no examplesBehavioral: Self affirmation, 5 items, no examples |
| Self-affirm, 3-item, No ex, Study 2 | Experimental | Behavioral: Self affirmation, 3 items, no examplesBehavioral: Self affirmation, 3 items, no examples |
| Self-affirm, 10-item, Write ex, Study 2 | Active comparator | Behavioral: Self affirmation, 10 items, written examplesBehavioral: Self affirmation, 10 items, written examples |
| Self-affirm, 5-item, Write ex, Study 2 | Experimental | Behavioral: Self affirmation, 5 items, written examplesBehavioral: Self affirmation, 5 items, written examples |
| Self-affirm, 3-item, Write ex, Study 2 | Experimental | Behavioral: Self affirmation, 3 items, written examplesBehavioral: Self affirmation, 3 items, written examples |
| Self-affirm, 10-item, Imagine ex, Study2 | Experimental | Behavioral: Self affirmation, 10 items, imagined examplesBehavioral: Self affirmation, 10 items, imagined examples |
| Self-affirm, 5-item, Imagine ex, Study 2 | Experimental | Behavioral: Self affirmation, 5 items, imagined examplesBehavioral: Self affirmation, 5 items, imagined examples |
| Self-affirm, 3-item, Imagine ex, Study 2 | Experimental | Behavioral: Self affirmation, 3 items, imagined examplesBehavioral: Self affirmation, 3 items, imagined examples |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self affirmation, 10 items, written examplesParticipants will complete the 10 item self-affirmation kindness quiz and will be asked to provide written examples for each item they respond "yes" to. | Behavioural | Self-affirm, 10-item, Write ex, Study 2, Self-affirm, Write examples, Study 1 |
| Self affirmation, 10 items, no examplesParticipants will complete the 10 item self-affirmation kindness quiz and will not be asked to provide examples for any items they respond "yes" to. | Behavioural | Self-affirm, 10-item, No ex, Study 2, Self-affirm, No examples, Study 1 |
| Self affirmation, 10 items, imagined examplesParticipants will complete the 10 item self-affirmation kindness quiz and will be asked to imagine examples for each item they respond "yes" to. | Behavioural | Self-affirm, 10-item, Imagine ex, Study2, Self-affirm, Imagine examples, Study 1 |
| Self affirmation, 5 items, written examplesParticipants will complete a 5 item self-affirmation kindness quiz and will be asked to provide written examples for each item they respond "yes" to. | Behavioural | Self-affirm, 5-item, Write ex, Study 2 |
| Self affirmation, 5 items, no examplesParticipants will complete a 5 item self-affirmation kindness quiz and will not be asked to provide examples for any items they respond "yes" to. | Behavioural | Self-affirm, 5-item, No ex, Study 2 |
| Self affirmation, 5 items, imagined examplesParticipants will complete a 5 item self-affirmation kindness quiz and will be asked to imagine examples for each item they respond "yes" to. | Behavioural | Self-affirm, 5-item, Imagine ex, Study 2 |
| Self affirmation, 3 items, written examplesParticipants will complete a 3 item self-affirmation kindness quiz and will be asked to provide written examples for each item they respond "yes" to. | Behavioural | Self-affirm, 3-item, Write ex, Study 2 |
| Self affirmation, 3 items, no examplesParticipants will complete a 3 item self-affirmation kindness quiz and will not be asked to provide examples for any items they respond "yes" to. | Behavioural | Self-affirm, 3-item, No ex, Study 2 |
| Self affirmation, 3 items, imagined examplesParticipants will complete a 3 item self-affirmation kindness quiz and will be asked to imagine examples for each item they respond "yes" to. | Behavioural | Self-affirm, 3-item, Imagine ex, Study 2 |
Primary outcome
Defensive Avoidance
Time frame: immediately post-intervention
Indicator of defensive information processing, 3 items (Witte)
Reactance
Time frame: immediately post-intervention
Indicator of defensive information processing, 27 items (Hall et al., 2016)
Yielding
Time frame: immediately post-intervention
Indicator of defensive information processing, 7 items (Brennan et al., 2011, 2014)
Intentions to quit smoking in the next 3 months
Time frame: immediately post-intervention
Intentions to quit smoking, 3 items
7 secondary outcomes
Cognitive perceived likelihood of developing smoking related disease
Time frame: immediately post-intervention
Perceived severity
Time frame: immediately post-intervention
Response efficacy of quitting smoking
Time frame: immediately post-intervention
Self-efficacy to quit smoking
Time frame: immediately post-intervention
Affective perceived likelihood
Time frame: immediately post-intervention
Anticipated regret
Time frame: immediately post-intervention
Worry
Time frame: immediately post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- BackgroundReed, M. B., & Aspinwall, L. G. (1998). Self-affirmation reduces biased processing of health-risk information. Motivation and Emotion, 22(2), 99-132.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer M Taber, PhD principal investigator
Kent State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self affirmation, 10 items, written examples, Self affirmation, 10 items, no examples and Self affirmation, 10 items, imagined examples in people with Smoking and Smoking Cessation, run by Kent State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defensive Avoidance (time frame: immediately post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03405220, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.