Version 2 of the Smoking Cessation Smartphone App "Smiling Instead of Smoking" (SiS)

NCT03951766 | Completed Results DMC

• 1 other identifier: 2018P002699
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this pilot study is to solicit feedback from nondaily smokers looking for smoking cessation support online (n=90) about Version 2 of a smartphone app investigators designed to support smoking cessation, and to test if within-person theorized mechanisms of change are occurring as participants undergo the app-assisted quit attempt. Data sources will be passively collected smartphone app usage data, surveys and, in a sub-sample (n=20), online video-conference user feedback sessions. Results will be used to guide the design of Version 3.0 of the "Smiling Instead of Smoking" (SiS) smartphone app. Specifically, the aims of this study are to:

1. 1.Assess ease-of-use and helpfulness of the app, as rated by app users 6 weeks after their chosen smoking cessation date
2. 2.Test if within-person changes occur in theorized mechanisms of behavior change as nondaily smokers undergo a SiS app assisted quit attempt
3. 3.Identify app features in need of improvement, as identified by passively recorded app usage patterns, REDCap open-ended survey items, and, in a sub-sample, user feedback sessions (n=20)

Conditions

Smoking Cessation; Smoking, Tobacco

Keywords

mHealth; smartphone; smoking cessation; app; happiness; positive psychology; nondaily smoking

Outcome Measures

Primary Outcomes (1)

• Ease-of-use and Helpfulness of the App

  As rated by app users 6 weeks after their chosen smoking cessation date via open-ended REDCap survey. This survey asks questions concerning feasibility, usefulness, and overall opinions of specific app features. Responses were rated on 4-point Likert-scales with ease-of-use rated with the options 0 = Not easy at all \| 1 = Somewhat easy to use \| 2 = Easy to use \| 3 = Very easy to use, and usefulness rated with the options 0 = Not at all useful \| 1 = Somewhat useful \| 2 = Useful \| 3 = Very useful. For both ease-of-use and usefulness items, scores range from 0 to 3 with higher scores indicating a better opinion of the app features.

  6 weeks after chosen smoking cessation date

Secondary Outcomes (14)

• Within-person Changes in Theorized Mechanism of Behavior Change - Questionnaire of Smoking Urges (Cox et al., 2001)

  Baseline, 2-weeks, and 6-weeks post-quit

• Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Urges Measure

  Baseline, 2-weeks, and 6-weeks post-quit

• Within-person Changes in Theorized Mechanism of Behavior Change - Positive and Negative Affect Schedule (Watson et al., 1988)

  Baseline, 2-weeks, and 6-weeks post-quit

• Within-person Changes in Theorized Mechanism of Behavior Change - Subjective Happiness Scale (Lyubomirsky & Lepper, 1999)

  Baseline, 2-weeks, and 6-weeks post-quit

• Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Happiness Measures

  Baseline, 2-weeks, and 6-weeks post-quit

Other Outcomes (2)

• Features of App That Need Improvement - App Usage

  6 weeks after chosen smoking cessation date

• Self-reported Smoking Status

  Baseline, 2 weeks post-quit, 6 weeks post-quit, 3-months post-quit, 6-months post-quit

Study Arms (1)

Smiling Instead of Smoking App

OTHER

This is a pilot study; all participants will use the app in the same manner/time period.

Behavioral: Smiling Instead of Smoking (SiS) App Version 2

Interventions

Smiling Instead of Smoking (SiS) App Version 2 BEHAVIORAL

The investigators have developed a smartphone app that acts as a behavioral, in-the-pocket coach and uses positive psychology exercises to enhance quitting success. It is anonymous, portable, and provides just-in-time support, an important feature for smokers who smoke under specific conditions and circumstances. To support treatment, investigators use a positive psychology approach. The smartphone app administers positive psychology exercises to enhance and/or maintain positive affect, which is hypothesized to stimulate nondaily smokers to enact healthier alternatives to smoking by broadening their thought-action repertoire, increasing confidence, and decreasing craving and defensiveness about smoking-related health information.

Smiling Instead of Smoking App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Owns a smartphone
• Is a nondaily smoker, who smokes at least weekly and no more than 25 out of the past 30 days
• Has a current intention to quit smoking
• Interested in using a smartphone app to quit smoking

You may not qualify if:

• Under 18 years of age
• Does not own a smartphone
• Is not a nondaily smoker, who smokes at least weekly and no more than 25 out of the past 30 days
• Does not have a current intention to quit smoking
• Is not interested in using a smartphone app to quit smoking

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (11)

• Cox LS, Tiffany ST, Christen AG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory and clinical settings. Nicotine Tob Res. 2001 Feb;3(1):7-16. doi: 10.1080/14622200020032051.

  PMID: 11260806 BACKGROUND

• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

  PMID: 3397865 BACKGROUND

• Etter JF, Bergman MM, Humair JP, Perneger TV. Development and validation of a scale measuring self-efficacy of current and former smokers. Addiction. 2000 Jun;95(6):901-13. doi: 10.1046/j.1360-0443.2000.9569017.x.

  PMID: 10946439 BACKGROUND

• Etter JF, Humair JP, Bergman MM, Perneger TV. Development and validation of the Attitudes Towards Smoking Scale (ATS-18). Addiction. 2000 Apr;95(4):613-25. doi: 10.1046/j.1360-0443.2000.95461312.x.

  PMID: 10829336 BACKGROUND

• Kahler CW, Lachance HR, Strong DR, Ramsey SE, Monti PM, Brown RA. The commitment to quitting smoking scale: initial validation in a smoking cessation trial for heavy social drinkers. Addict Behav. 2007 Oct;32(10):2420-4. doi: 10.1016/j.addbeh.2007.04.002. Epub 2007 Apr 6.

  PMID: 17478057 BACKGROUND

• Asher MK, Martin RA, Rohsenow DJ, MacKinnon SV, Traficante R, Monti PM. Perceived barriers to quitting smoking among alcohol dependent patients in treatment. J Subst Abuse Treat. 2003 Mar;24(2):169-74. doi: 10.1016/s0740-5472(02)00354-9.

  PMID: 12745034 BACKGROUND

• Ward RM, Velicer WF, Rossi JS, Fava JL, Prochaska JO. Factorial invariance and internal consistency for the decisional balance inventory--short form. Addict Behav. 2004 Jul;29(5):953-8. doi: 10.1016/j.addbeh.2004.02.042.

  PMID: 15219341 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.

  PMID: 16250744 BACKGROUND

• Lyubomirsky, S., & Lepper, H. (1999). A measure of subjective happiness: Preliminary reliability and construct validation. Social Indicators Research, 46, 137-155.

  BACKGROUND

• Hoepper BB, Siegel KR, Carlon HA, Kahler CW, Park ER, Taylor ST, Simpson HV, Hoeppner SS. Feature-Level Analysis of a Smoking Cessation Smartphone App Based on a Positive Psychology Approach: Prospective Observational Study. JMIR Form Res. 2022 Jul 28;6(7):e38234. doi: 10.2196/38234.

  PMID: 35900835 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Tobacco Smoking; Alzheimer Disease

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking; Tobacco Use; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Bettina Hoeppner
• Organization: Massachusetts General Hospital, Psychiatry Department

bhoeppner@mgh.harvard.edu

6176431988

Study Officials

• Bettina B Hoeppner, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Pilot study: all participants will use the smartphone app for a total of 7 weeks.

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 15, 2019
• Study Start: June 24, 2019
• Primary Completion: January 8, 2020
• Study Completion: June 8, 2020
• Last Updated: July 26, 2022
• Results First Posted: September 9, 2021

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)