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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Aug 2, 2023
Date Accepted: Oct 10, 2023

The final, peer-reviewed published version of this preprint can be found here:

Digital Therapeutic Intervention for Women in the UK Armed Forces Who Consume Alcohol at a Hazardous or Harmful Level: Protocol for a Randomized Controlled Trial

Williamson G, Carr E, Fear NT, Dymond S, King K, Simms A, Goodwin L, Murphy D, Leightley D

Digital Therapeutic Intervention for Women in the UK Armed Forces Who Consume Alcohol at a Hazardous or Harmful Level: Protocol for a Randomized Controlled Trial

JMIR Res Protoc 2023;12:e51531

DOI: 10.2196/51531

PMID: 38113103

PMCID: 10762616

Supporting women in the UK Armed Forces with a digital therapeutic that consume alcohol at a hazardous or harmful level: Protocol for a Randomized Controlled Trial

  • Grace Williamson; 
  • Ewan Carr; 
  • Nicola T. Fear; 
  • Simon Dymond; 
  • Kate King; 
  • Amos Simms; 
  • Laura Goodwin; 
  • Dominic Murphy; 
  • Daniel Leightley

ABSTRACT

Background:

Alcohol misuse is common in the United Kingdom (UK) Armed Forces (AF), with prevalence significantly higher than in the general population. To date, digital health initiatives to support alcohol misuse have focused on males, which represents around 89% of the AF. However, woman veterans drink disproportionally more than woman members of the public.

Objective:

This is a two-arm participant-blinded (single-blinded) confirmatory randomized controlled trial (RCT) aims to assess the efficacy of a brief alcohol intervention (DrinksRation) in reducing weekly self-reported alcohol consumption between baseline and 3 months follow-up (day 84) among woman who have served in the UK AF.

Methods:

In this two-arm, single-blinded RCT, a smartphone app that includes interactive features tailored towards the needs of woman veterans and designed to enhance participants’ motivations to reduce the amount of alcohol they consume is compared with governance guidance on alcohol consumption. The trial will be conducted in woman who have served at least one day of paid service in the UK AF. Recruitment, consent, and data collection will be carried out automatically through the DrinksRation app, or BeAlcoholSmart platform. The primary outcome is change in self-reported weekly alcohol consumption between baseline (day 0) and 3-month follow-up (day 84) measured using the Time-Line Follow back for Alcohol Consumption. The secondary outcome is the change in Alcohol Use Disorder Identification score, measured at baseline and 3-month follow-up between the control and intervention groups. Process evaluation measures include (1) app use and (2) usability ratings as measured by the mHealth App Usability Questionnaire.

Results:

RCT recruitment will begin in October 2023 and last for 5 months. We aim to complete all data collection, including interviews, by February 2024.

Conclusions:

This study will assess whether a smartphone app tailored to the needs woman who have served in the UK AF is efficacious in reducing self-reported alcohol consumption. If successful, the digital therapeutics platform could be used to support woman who have served in the UK AF, but also other conditions and disorders. Clinical Trial: This study has prospectively been registered on ClinicalTrials.Gov (trial registration: NCT05970484).


 Citation

Please cite as:

Williamson G, Carr E, Fear NT, Dymond S, King K, Simms A, Goodwin L, Murphy D, Leightley D

Digital Therapeutic Intervention for Women in the UK Armed Forces Who Consume Alcohol at a Hazardous or Harmful Level: Protocol for a Randomized Controlled Trial

JMIR Res Protoc 2023;12:e51531

DOI: 10.2196/51531

PMID: 38113103

PMCID: 10762616

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