Integrating self-affirmation content into a smoking cessation mobile app

Plain English Summary

Background and study aims
Most smokers attempt to stop using cigarettes numerous times before successfully quitting. Cigarette cravings may undermine perceived competence to quit and thus constitute psychological threats to the self-concept. Self-affirmation may promote smoking cessation by offsetting these threats. This study examines whether self-affirmation is associated with smoking cessation in the context of a cessation app. A total of two types of self-affirmation are examined: tendency to spontaneously self-affirm and self-affirmation inductions added to a publicly available smoking cessation app (Smoke-Free Quit Smoking Now). This study had three aims: to assess the effect of induced self-affirmation conditions on smoking cessation outcomes (aim 1) and to assess the associations of spontaneous self-affirmation with smoking cessation outcomes (aim 2), and an exploratory aim to assess baseline optimism and baseline mood states (happiness, anger, anxiousness, hopefulness, sadness) as potential predictors and moderators of the relationship between affirmation conditions and cessation outcomes (aim 3).

Who can participate?
A random subset of adults (18-98) who downloaded the free version of the Smoke Free-Quit Smoking Now mobile application during the study period are shown a consent form and invited to participate. To be included, app users had to be adults (between the ages of 18-98), select a cessation date after the day they downloaded the app but not more than 14 days in the future and complete the baseline assessment.

What does the study involve?
Half of the participants are randomly allocated to complete a self-affirmation induction upon study entry. Participants are also randomly allocated to either receive self-affirming text notifications during their quit attempt or to receive conventional notifications. The induction and the text notifications are fully automated, and all data are collected through self-assessments in the mobile application, including the 1- and 3-month follow-up surveys.

What are the possible benefits and risks of participating?
Participants may experience an enhanced smoking cessation experience with the self-affirmation content.

Where is the study run from?
The study is conducted entirely online through the Smoke Free-Quit Smoking Now mobile application. The Smokefree mobile app was developed by Dr David Crane of 23 Ltd, based in London (UK).

When is the study starting and how long is it expected to run for?
January 2015 to March 2019

Who is funding the study?
National Cancer Institute (USA)

Who is the main contact?
1. Dr Bill Klein
kleinwm@nih.gov
2. Dr Elizabeth Seaman
eseaman@cdcfoundation.org

Study website

Type

Scientific

Contact name

Dr Elizabeth Seaman

ORCID ID

http://orcid.org/0000-0001-5218-4540

Contact details

600 Peachtree St NE #1000
Atlanta
30308
United States of America
+1 (0)4438524139
eseaman@cdcfoundation.org

Type

Public

Contact name

Dr Elizabeth Seaman

ORCID ID

http://orcid.org/0000-0001-5218-4540

Contact details

600 Peachtree St NE #1000
Atlanta
30308
United States of America
+1 (0)4438524139
eseaman@cdcfoundation.org

EudraCT/CTIS number

Nil known

IRAS number

ClinicalTrials.gov number

Nil known

Secondary identifying numbers

17CN039

Scientific title

Integrating the use of self-affirmation content into a mobile app to promote quit attempts with text-based smoking cessation intervention messaging

Acronym

SAMASC (Self-Affirmation in a Mobile App for Smoking Cessation)

Study hypothesis

This study had two primary aims: to assess the effect of induced self-affirmation conditions added into the Smoke Free-Quit Smoking Now mobile application on smoking cessation outcomes (aim 1) and to assess the associations of spontaneous self-affirmation with smoking cessation outcomes (aim 2).

It is hypothesized that two types of self-affirmation opportunities - a baseline kindness quiz and self-affirming push notifications in the subsequent months - would promote cessation. It is also hypothesized that individuals with a tendency to spontaneously self-affirm at baseline would be more likely to successfully quit smoking.

Finally, an exploratory aim (aim 3) was to assess baseline optimism and baseline mood states (happiness, anger, anxiousness, hopefulness, sadness) as potential predictors and potential moderators of the relationship between affirmation conditions and cessation outcomes.

Ethics approval(s)

Approved 12/04/2018, the National Institutes of Health Intramural Institutional Review Board (Office of Human Subjects Research Protections, 6700B Rockledge Drive, Suite 4300, Bethesda, MD 20817, USA; +1 301 402 3713; irb@od.nih.gov), ref: #17CN039

Study design

Randomized 2 x 2 factorial design (integrated affirmation: affirmation texts present versus absent; baseline affirmation: questionnaire present versus absent)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Internet/virtual

Study type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet (shared with participants through mobile application screen)

Condition

Smoking cessation among current smokers

Intervention

Two types of self-affirmation inductions (Integrated, Baseline) were added to a publicly available smoking cessation mobile application (Smoke-Free Quit Smoking Now). All users who met the inclusion criteria, provided consent to participate and completed a baseline assessment, were randomized to 1 of 4 conditions. Half of the participants were randomly assigned to complete a self-affirmation induction upon study entry. Orthogonally, half of the participants were randomly assigned to receive self-affirming text notifications during their quit attempt or to receive conventional notifications. The induction and the text notifications were fully automated, and all data were collected through self-assessments in the mobile application. Self-reported smoking cessation was assessed 1 month and 3 months following study entry.

Intervention type

Behavioural

Primary outcome measure

Smoking cessation measured through self-assessments in the mobile application: past-week cessation at 1 month, past-month cessation at 1 month, past-week cessation at 3 months, and past-month cessation at 3 months

Secondary outcome measures

Optimism and baseline mood states (happiness, anger, anxiousness, hopefulness, sadness) measured through self-assessments in the mobile application at baseline

Overall study start date

12/01/2015

Overall study end date

06/03/2019

Reason abandoned (if study stopped)

Participant inclusion criteria

A randomly selected proportion of users who downloaded the free version of the Smoke Free-Quit Smoking Now mobile application during the study period (initially 10% and then increased to 30% to achieve recruitment goals) are shown a consent form and invited to participate in this study. Once participants who opted in completed the baseline assessment, their eligibility was determined. In order to participate, app users had to be:
1. Adults (between the ages of 18-98)
2. Selected a cessation date after the day they downloaded the app but not more than 14 days in the future
3. Completed the baseline assessment

Participant type(s)

Other

Age group

Adult

Lower age limit

18 Years

Upper age limit

98 Years

Sex

Both

Target number of participants

A sample size of 500 at the 1-month follow-up was calculated to be able to detect a small effect size estimate (F=.15), with high (.90) power using an analysis of variance (ANOVA) with 4 groups (calculated with G*Power)

Total final enrolment

7899

Participant exclusion criteria

1. Under 18 years or over 98 years old
2. Selected a quit date more than 14 days in the future or more than 1 day in the past
3. Paid for additional app features (Pro users)
4. Did not complete the baseline assessment

Recruitment start date

07/03/2018

Recruitment end date

05/02/2019

Countries of recruitment

Afghanistan, Åland Islands, Albania, Algeria, American Samoa, Andorra, Angola, Anguilla, Antarctica, Antigua and Barbuda, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Benin, Bermuda, Bhutan, Bolivia, Bonaire Saint Eustatius and Saba, Bosnia and Herzegovina, Botswana, Bouvet Island, Brazil, British Indian Ocean Territory, Brunei Darussalam, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Cabo Verde, Cayman Islands, Central African Republic, Chad, Chile, China, Christmas Island, Cocos (Keeling) Islands, Colombia, Comoros, Congo, Congo, Democratic Republic, Cook Islands, Costa Rica, Côte d'Ivoire, Croatia, Cuba, Curaçao, Cyprus, Czech Republic, Denmark, Djibouti, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, England, Equatorial Guinea, Eritrea, Estonia, Ethiopia, Falkland Islands, Faroe Islands, Fiji, Finland, France, French Guiana, French Polynesia, French Southern Territories, Gabon, Gambia, Georgia, Germany, Ghana, Gibraltar, Greece, Greenland, Grenada, Guadeloupe, Guam, Guatemala, Guernsey, Guinea, Guinea-Bissau, Guyana, Haiti, Heard Island and McDonald Islands, Holy See (Vatican City State), Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Isle of Man, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kiribati, Korea, North, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Lesotho, Liberia, Libya, Liechtenstein, Lithuania, Luxembourg, Macao, North Macedonia, Madagascar, Malawi, Malaysia, Maldives, Mali, Malta, Marshall Islands, Martinique, Mauritania, Mauritius, Mayotte, Mexico, Micronesia, Federated States of, Moldova, Monaco, Mongolia, Montenegro, Montserrat, Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Niger, Nigeria, Niue, Norfolk Island, Northern Mariana Islands, Norway, Oman, Pakistan, Palau, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Pitcairn, Poland, Portugal, Puerto Rico, Qatar, Réunion, Romania, Russian Federation, Rwanda, Saint Barthélemy, Saint Helena, Ascension and Tristan da Cunha, Saint Kitts and Nevis, Saint Lucia, Saint Martin (French part), Saint Pierre and Miquelon, Saint Vincent and the Grenadines, Samoa, San Marino, Sao Tome and Principe, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Sint Maarten (Dutch part), Slovakia, Slovenia, Solomon Islands, Somalia, South Africa, South Georgia and the South Sandwich Islands, South Sudan, Spain, Sri Lanka, Sudan, Suriname, Svalbard and Jan Mayen, Eswatini, Sweden, Switzerland, Syria, Taiwan, Tajikistan, Tanzania, Thailand, Timor-Leste, Togo, Tokelau, Tonga, Trinidad and Tobago, Tunisia, Türkiye, Turkmenistan, Turks and Caicos Islands, Tuvalu, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States Minor Outlying Islands, United States of America, Uruguay, Uzbekistan, Vanuatu, Venezuela, Viet Nam, Virgin Islands, British, Virgin Islands, U.S., Wallis and Futuna, Western Sahara, Yemen, Zambia, Zimbabwe

Study participating centre

Smoke Free (23 Ltd)
This study took place entirely online - mobile app users from any country were able to participate. Most participants were from the United Kingdom, closely followed by the United States.
London
WC2H 9JQ
United Kingdom

Organisation

National Cancer Institute

Sponsor details

9609 Medical Center Drive
Rockville
20850
United States of America
+1 (0)800 422 6237
NCIinfo@nih.gov

Sponsor type

Government

Website

http://www.cancer.gov/

ROR

https://ror.org/040gcmg81

Funder type

Government

Funder name

National Cancer Institute

Alternative name(s)

Instituto Nacional del Cáncer, NCI

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United States of America

Publication and dissemination plan

The researchers are preparing a manuscript to be published in the Journal of Medical Information Research (JMIR)

Intention to publish date

01/03/2021

Individual participant data (IPD) Intention to share

No

IPD sharing plan

During study planning and protocol preparation, the researchers did not plan to make participant-level data available publicly and did not include this provision in the IRB application and in the trial information they sent to participants. At this point, it would be problematic to change the protocol for data sharing/availability without going back to the IRB and participants to get approval for this new plan. It would be impossible to re-contact participants to get their approval for their de-identified data to be shared, since all data collection took place through the smartphone application. Thus, the researchers are unable to change the protocol and study information to make participant-level data publicly available. Data will be held by study investigators on secure, password-protected laptops.

IPD sharing plan summary

Not expected to be made available

Study outputs