Panacea Index Logo

Command Palette

Search for a command to run...

Combining app-based behavioral therapy with electronic cigarettes for smoking cessation: a study protocol for a single-arm mixed-methods pilot trial.

Addiction science & clinical practice
January 1, 1970
Helen Schiek et al. (4 authors)
Journal ArticleClinical Trial ProtocolHuman StudyClinical
Study Details

Study Goal

The researchers aimed to investigate the initial efficacy, acceptability, and psychological outcomes of a smoking cessation intervention combining a mobile app with mindfulness-informed principles and an electronic cigarette.

Results Summary

The study is ongoing, so no results regarding mindfulness effects are yet available. The abstract outlines the planned methodology and outcomes but does not report findings.

Population

Adults who smoke and are motivated to quit.

Effective Dosage

Not specified

Duration

6 months (with at least 3 months of electronic cigarette use)

Interactions

None mentioned

Extracted Claims (6)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Nuumi smoking cessation program integrating a digital behavioral therapy and an electronic cigarette
decrease
smoking cessation
adults who smoke and who are motivated to quit
-
may provide a solution
#1
mobile phone app and an electronic cigarette
decrease
smoking cessation
adults who smoke and who are motivated to quit
-
investigate the initial efficacy, acceptability and psychological outcomes
#2
app and an electronic cigarette with pods containing nicotine
neutral
patterns of use
adults who smoke and who are motivated to quit
at least 3 months
temporary use
#3
behavioral therapy
decrease
smoking cessation
adults who smoke and who are motivated to quit
-
leverages evidence-based content
#4
nuumi intervention
decrease
smoking cessation
adults who smoke
-
will provide insights into the initial efficacy, acceptability, and psychological outcomes
#5
novel mobile health intervention for smoking cessation
decrease
smoking cessation
adults who smoke
-
may generate an effective intervention
#6
Abstract

BACKGROUND: Cigarette smoking remains a leading cause of preventable illness and death, underscoring the need for effective evidence-based smoking cessation interventions. Nuumi, a novel smoking cessation program integrating a digital behavioral therapy and an electronic cigarette, may provide a solution. OBJECTIVE: To investigate the initial efficacy, acceptability and psychological outcomes of an evidence-based smoking cessation intervention comprised of a mobile phone app and an electronic cigarette among adults who smoke and who are motivated to quit. METHODS: A prospective 6-month single-arm mixed-methods pilot study will be conducted. Seventy adults who smoke and who are motivated to quit will be recruited via web-based advertisements and flyers. Participants receive access to an app and an electronic cigarette with pods containing nicotine for temporary use of at least 3 months. The electronic cigarette is coupled with the app via Bluetooth, allowing for tracking of patterns of use. The behavioral therapy leverages evidence-based content informed by cognitive behavioral therapy and mindfulness-informed principles. Web-based self-report surveys will be conducted at baseline, at 4 weeks, at 8 weeks, at 12 weeks, and at 24 weeks post-baseline. Semi-structured interviews will be conducted at baseline and at 12 weeks post-baseline. Primary outcomes will be self-reported 7-day point prevalence abstinence from smoking at 12 weeks and 24 weeks. Secondary outcomes will include other smoking cessation-related outcomes, psychological outcomes, and acceptability of the nuumi intervention. Descriptive analyses and within-group comparisons will be performed on the quantitative data, and content analyses will be performed on the qualitative data. Recruitment for this study started in October 2023. DISCUSSION: As tobacco smoking is a leading cause of preventable morbidity and mortality, this research addresses one of the largest health burdens of our time. The results will provide insights into the initial efficacy, acceptability, and psychological outcomes of a novel mobile health intervention for smoking cessation. If successful, this pilot may generate an effective intervention supporting adults who smoke to quit smoking. The results will inform feasibility of a future randomized controlled trial. Trial Registration German Clinical Trials Register DRKS00032652, registered 09/15/2023, https://drks.de/search/de/trial/DRKS00032652 .

Medical Subject Headings (MeSH)
AdultFemaleHumansMaleBehavior TherapyCognitive Behavioral TherapyElectronic Nicotine Delivery SystemsMobile ApplicationsPilot ProjectsProspective StudiesSmoking CessationClinical Trials as Topic
Study Links
Quality Scores
SafetyNot Assessed
Quality75/10
Citation Metrics
Total Citations1
Citations/Year1.0
Research Impact Scores
APT Score0.25
Weight Score1.37
Normalized Score0.55
Related Supplements