Integrating self-affirmation content into a smoking cessation mobile app

ISRCTN	ISRCTN56646695
DOI	https://doi.org/10.1186/ISRCTN56646695
Secondary identifying numbers	17CN039

Submission date: 11/02/2021
Registration date: 12/02/2021
Last edited: 08/03/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Contact information

Dr Elizabeth Seaman
Scientific

600 Peachtree St NE #1000
Atlanta
30308
United States of America

ORCID ID	0000-0001-5218-4540
Phone	+1 (0)4438524139
Email	eseaman@cdcfoundation.org

Dr Elizabeth Seaman
Public

600 Peachtree St NE #1000
Atlanta
30308
United States of America

ORCID ID	0000-0001-5218-4540
Phone	+1 (0)4438524139
Email	eseaman@cdcfoundation.org

Study information

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
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet (shared with participants through mobile application screen)
Scientific title	Integrating the use of self-affirmation content into a mobile app to promote quit attempts with text-based smoking cessation intervention messaging
Study 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
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

Eligibility

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 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 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

Locations

Countries of recruitment

Afghanistan
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
Cabo Verde
Cambodia
Cameroon
Canada
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos (Keeling) Islands
Colombia
Comoros
Congo
Congo, Democratic Republic
Cook Islands
Costa Rica
Croatia
Cuba
Curaçao
Cyprus
Czech Republic
Côte d'Ivoire
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
England
Equatorial Guinea
Eritrea
Estonia
Eswatini
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
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
North Macedonia
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestine, State of
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Romania
Russian Federation
Rwanda
Réunion
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
Sweden
Switzerland
Syria
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkmenistan
Turks and Caicos Islands
Tuvalu
Türkiye
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
Åland Islands

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

Sponsor information

National Cancer Institute
Government

9609 Medical Center Drive
Rockville
20850
United States of America

Phone	+1 (0)800 422 6237
Email	NCIinfo@nih.gov
Website	http://www.cancer.gov/
"ROR"	https://ror.org/040gcmg81

Funders

Funder type

Government

National Cancer Institute
Government organisation / National government

Alternative name(s): Instituto Nacional del Cáncer, National Cancer Institute at the National Institutes of Health, Instituto Nacional del Cáncer de los Institutos Nacionales de la Salud, NCI
Location: United States of America

Results and Publications

Intention to publish date	01/03/2021
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	The researchers are preparing a manuscript to be published in the Journal of Medical Information Research (JMIR)
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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	1-month follow-up results	05/03/2021	08/03/2021	Yes	No

Editorial Notes

08/03/2021: Publication reference added.
12/02/2021: Trial's existence confirmed by the National Institutes of Health Intramural Institutional Review Board.