Number of Quit AttemptsNCT03027466
Integrating Use of Self-Affirmation Content Into a Mobile App to Promote Quit Attempts With Text-Based Smoking Cessation Intervention Messaging
A study testing Self-affirmation induction in people with Number of Quit Attempts, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Quitting smoking is hard. It is easy to relapse. Smokers may think of temptation to smoke as a threat if they think it suggests that they are unable to meet the challenges of stopping. When people feel such a threat to their sense of self-identity, they may get defensive. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Number of Quit Attempts
- What is being tested?
- Self-affirmation induction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,899 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2018to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Because the app is designed to assist with smoking cessation, all smokers are eligible to participate.
- Subjects are eligible if they are 18+ years of age.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Background:
Quitting smoking is hard. It is easy to relapse. Smokers may think of temptation to smoke as a threat if they think it suggests that they are unable to meet the challenges of stopping. When people feel such a threat to their sense of self-identity, they may get defensive. They may want to downplay the importance of quitting. This could make them try to quit less. Self-affirmation is a process of focusing on strengths and values. This can offset threats to the self and promote healthier behavior.
Read more
Objective:
To explore people s values, smoking attitudes, and smoking behavior.
Eligibility:
People ages 18 and older who smoke
Design:
The study takes place entirely on a mobile device.
Participants will give their age, gender, data about their smoking habits, and desired quit date.
Then they will get different texts about quitting.
Participants will answer follow-up surveys 1 and 3 months later.
...
Read the detailed description
Quitting smoking is challenging and relapse is likely. Smokers may perceive temptation to smoke as threatening if they think it suggests that they are unable to meet the challenges of cessation. When individuals experience such a threat to their sense of self-identity (e.g., to their sense that they have integrity and/ or competence), they often respond defensively. Individuals have a tendency to react defensively to information that informs them that their behavior increases risk for a particular disease or negative health consequences. Self-affirmation a process through which individuals focus on their strengths and values can offset threats to the self and promote healthier behaviors, including smoking cessation. To the extent that relapse or difficulty quitting is perceived as a threat to self-identity, when individuals are presented with the opportunity to self-affirm they may perceive failure as less threatening, mitigating the motivation to downplay the importance of quitting. Preliminary evidence suggests that self-affirmation can be feasibly incorporated into an existing smoking cessation text message-based intervention, and may bolster cessation rates among users motivated to quit smoking. Here, we propose to extend that research by examining whether the addition of self-affirmation text messages to a smoking cessation app (Smoke Free United Kingdom (UK) promotes smoking cessation, compared to standard of care (i.e., existing app content only). Importantly, self-affirmation material will be incorporated into the current app and will not change the goals or nature of the original texting program. We predict that the individuals in the self-affirmation condition will be more likely to report being smoke-free at the 1-month and 3-month follow-ups.
- Conditions
- Number of Quit Attempts
- Being tested
- Self-affirmation induction
- Keywords
- Quitting Smoking, Phone Application
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-affirmation inductionBehavioural
Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
| Study group | Role | What they receive |
|---|---|---|
| Baseline Affirmation and Affirmation Texts | Experimental | Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study and will receive affirmation text messages throughout the study Receives: Behavioral: Self-affirmation induction |
| Baseline Affirmation and No Affirmation Texts | Active comparator | Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study but will not receive affirmation text messages throughout the study Receives: Behavioral: Self-affirmation induction |
| No Baseline Affirmation and Affirmation Texts | Active comparator | Participants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study Receives: Behavioral: Self-affirmation induction |
| No Baseline Affirmation and No Affirmation Texts | Placebo comparator | Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages) Receives: Behavioral: Self-affirmation induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months
Participants were asked to report the number of times they attempted to quit smoking at 1 month and 3 months.
Measured: 1 month and 3 months
Secondary outcomes (2)
Number of Days Participants Remained Smoke-free at the 1 and 3 Month Follow-up
Participants were asked the number of days they have remained smoke-free at the 1 and 3 month follow-up.
Measured: 1 month and 3 months follow-up
Type of Tobacco Products
Participants will be asked the type of tobacco products they use at the 1 and 3 month follow-up.
Measured: 1 month and 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start6 Mar 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Number of Quit AttemptsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,899 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, William Klein, Ph.D., National Cancer Institute (NCI)
- Investigators
- William M Klein, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027466
- Sponsor's protocol ID
- 999917039
- Other IDs
- 17-C-N039
- Status last verified
- Jul 2021
- First submitted
- 18 Jan 2017
- Last updated
- 23 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armitage CJ, Harris PR, Hepton G, Napper L. Self-affirmation increases acceptance of health-risk information among UK adult smokers with low socioeconomic status. Psychol Addict Behav. 2008 Mar;22(1):88-95. doi: 10.1037/0893-164X.22.1.88.
PubMed 18298234Spohr SA, Nandy R, Gandhiraj D, Vemulapalli A, Anne S, Walters ST. Efficacy of SMS Text Message Interventions for Smoking Cessation: A Meta-Analysis. J Subst Abuse Treat. 2015 Sep;56:1-10. doi: 10.1016/j.jsat.2015.01.011. Epub 2015 Feb 2.
PubMed 25720333Cohen GL, Garcia J, Purdie-Vaughns V, Apfel N, Brzustoski P. Recursive processes in self-affirmation: intervening to close the minority achievement gap. Science. 2009 Apr 17;324(5925):400-3. doi: 10.1126/science.1170769.
PubMed 19372432Seaman EL, Robinson CD, Crane D, Taber JM, Ferrer RA, Harris PR, Klein WMP. Association of Spontaneous and Induced Self-Affirmation With Smoking Cessation in Users of a Mobile App: Randomized Controlled Trial. J Med Internet Res. 2021 Mar 5;23(3):e18433. doi: 10.2196/18433.
PubMed 33666561
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Use of Self-Affirmation Content Into a Mobile App to Promote Quit Attempts With Text-Based Smoking Cessation Intervention Messaging
- ClinicalTrials.gov ID
- NCT03027466
- Acronym / sponsor ID
- 999917039
- Conditions
- Number of Quit Attempts
- Keywords
- Quitting Smoking, Phone Application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,899 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Posted 23 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Quitting smoking is hard. It is easy to relapse. Smokers may think of temptation to smoke as a threat if they think it suggests that they are unable to meet the challenges of stopping. When people feel such a threat to their sense of self-identity, they may get defensive. They may want to downplay the importance of quitting. This could make them try to quit less. Self-affirmation is a process of focusing on strengths and values. This can offset threats to the self and promote healthier behavior.
Objective:
To explore people s values, smoking attitudes, and smoking behavior.
Eligibility:
People ages 18 and older who smoke
Design:
The study takes place entirely on a mobile device.
Participants will give their age, gender, data about their smoking habits, and desired quit date.
Then they will get different texts about quitting.
Participants will answer follow-up surveys 1 and 3 months later.
...
Detailed description
Quitting smoking is challenging and relapse is likely. Smokers may perceive temptation to smoke as threatening if they think it suggests that they are unable to meet the challenges of cessation. When individuals experience such a threat to their sense of self-identity (e.g., to their sense that they have integrity and/ or competence), they often respond defensively. Individuals have a tendency to react defensively to information that informs them that their behavior increases risk for a particular disease or negative health consequences. Self-affirmation a process through which individuals focus on their strengths and values can offset threats to the self and promote healthier behaviors, including smoking cessation. To the extent that relapse or difficulty quitting is perceived as a threat to self-identity, when individuals are presented with the opportunity to self-affirm they may perceive failure as less threatening, mitigating the motivation to downplay the importance of quitting. Preliminary evidence suggests that self-affirmation can be feasibly incorporated into an existing smoking cessation text message-based intervention, and may bolster cessation rates among users motivated to quit smoking. Here, we propose to extend that research by examining whether the addition of self-affirmation text messages to a smoking cessation app (Smoke Free United Kingdom (UK) promotes smoking cessation, compared to standard of care (i.e., existing app content only). Importantly, self-affirmation material will be incorporated into the current app and will not change the goals or nature of the original texting program. We predict that the individuals in the self-affirmation condition will be more likely to report being smoke-free at the 1-month and 3-month follow-ups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Baseline Affirmation and Affirmation Texts | Experimental | Behavioral: Self-affirmation inductionParticipants will be given a "Baseline Affirmation" Quiz at the beginning of the study and will receive affirmation text messages throughout the study |
| Baseline Affirmation and No Affirmation Texts | Active comparator | Behavioral: Self-affirmation inductionParticipants will be given a "Baseline Affirmation" Quiz at the beginning of the study but will not receive affirmation text messages throughout the study |
| No Baseline Affirmation and Affirmation Texts | Active comparator | Behavioral: Self-affirmation inductionParticipants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study |
| No Baseline Affirmation and No Affirmation Texts | Placebo comparator | Behavioral: Self-affirmation inductionParticipants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Because the app is designed to assist with smoking cessation, all smokers are eligible to participate.
- Subjects are eligible if they are 18+ years of age.
Key exclusion criteria (0 listed)
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 inductionParticipants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message. | Behavioural | Baseline Affirmation and Affirmation Texts, Baseline Affirmation and No Affirmation Texts, No Baseline Affirmation and Affirmation Texts, No Baseline Affirmation and No Affirmation Texts |
Primary outcome
Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months
Time frame: 1 month and 3 months
Participants were asked to report the number of times they attempted to quit smoking at 1 month and 3 months.
2 secondary outcomes
Number of Days Participants Remained Smoke-free at the 1 and 3 Month Follow-up
Time frame: 1 month and 3 months follow-up
Type of Tobacco Products
Time frame: 1 month and 3 months follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18298234Armitage CJ, Harris PR, Hepton G, Napper L. Self-affirmation increases acceptance of health-risk information among UK adult smokers with low socioeconomic status. Psychol Addict Behav. 2008 Mar;22(1):88-95. doi: 10.1037/0893-164X.22.1.88.
- Background: PubMed 25720333Spohr SA, Nandy R, Gandhiraj D, Vemulapalli A, Anne S, Walters ST. Efficacy of SMS Text Message Interventions for Smoking Cessation: A Meta-Analysis. J Subst Abuse Treat. 2015 Sep;56:1-10. doi: 10.1016/j.jsat.2015.01.011. Epub 2015 Feb 2.
- Background: PubMed 19372432Cohen GL, Garcia J, Purdie-Vaughns V, Apfel N, Brzustoski P. Recursive processes in self-affirmation: intervening to close the minority achievement gap. Science. 2009 Apr 17;324(5925):400-3. doi: 10.1126/science.1170769.
- Results publication: PubMed 33666561Seaman EL, Robinson CD, Crane D, Taber JM, Ferrer RA, Harris PR, Klein WMP. Association of Spontaneous and Induced Self-Affirmation With Smoking Cessation in Users of a Mobile App: Randomized Controlled Trial. J Med Internet Res. 2021 Mar 5;23(3):e18433. doi: 10.2196/18433.
- Individual participant dataSharing planned: No
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.
William M Klein, Ph.D. principal investigator
National Cancer Institute (NCI)
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 induction in people with Number of Quit Attempts, run by National Cancer Institute (NCI) 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 2 inclusion and 0 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: finished, as of the sponsor's last update on 23 Jul 2021. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 23 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months (time frame: 1 month and 3 months). 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 NCT03027466, which also lists 4 linked publications.
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 23 Jul 2021.