# Usability of a digital mindfulness training program for smoking cessation: A mixed-method single-center pilot study protocol (HowToMind)

## TL;DR

This study tests a digital mindfulness app to help people quit smoking by evaluating its usability and acceptability in a pilot trial.

## Contribution

The novel contribution is a mixed-methods pilot study protocol for a digital mindfulness app to complement standard smoking cessation treatments.

## Key findings

- The study will assess app usability via the Mobile App Rating Scale and usage frequency.
- Participant feedback will guide adjustments to the app's content and functionality.
- The trial will inform a future large-scale randomized controlled trial on the app's effectiveness.

## Abstract

Tobacco use is one of the leading causes of preventable disease and death worldwide. Despite the availability of evidence-based pharmacological treatments, only a small number of individuals with tobacco use disorder achieve long-term abstinence after smoking cessation. This highlights the need to enhance existing interventions. In this protocol, we describe our single-center mixed-method trial, HowToMind, conducted in Dijon, France. This trial aims to investigate the usability and acceptability of a digital mindfulness-based intervention designed to complement standard smoking cessation treatment to potentiate its effects.

We will include 60 adults seeking treatment for tobacco use disorder, as defined by DSM-5 criteria, who wish to quit smoking and own a smartphone. All participants will receive a combination of transdermal and oral nicotine replacement therapy and will be introduced to an eHealth app that provides a digital equivalent of an 8-week mindfulness training program. The acceptability of the initial version of our app will be assessed based on usage frequency, and usability will be evaluated using the Mobile App Rating Scale (French version). A participatory approach will be employed through focus groups conducted at the end of the 8 weeks of app use, aimed at co-constructing the final version of the app based on participant feedback.

Our pilot mixed-method trial seeks to explore the usability and acceptability of our app, making necessary adjustments to its content and functionality based on participant feedback before its implementation in a large randomized controlled trial assessing the app’s potential to enhance the effects of standard treatment.

ClinicalTrials.gov, NCT06500117.