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. 2023 Dec 19:12:e51531.
doi: 10.2196/51531.

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

Grace Williamson #  1 , Ewan Carr #  2 , Nicola T Fear  1   3 , Simon Dymond  4   5 , Kate King  1   6 , Amos Simms  3 , Laura Goodwin  7 , Dominic Murphy  1   8 , Daniel Leightley  1
Affiliations

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

Grace Williamson et al. JMIR Res Protoc. .

Abstract

Background: Alcohol misuse is common in the United Kingdom Armed Forces (UKAF), with prevalence significantly higher than in the general population. To date, digital health initiatives to support alcohol misuse have focused on male individuals, who represent approximately 89% of the UKAF. However, female veterans drink disproportionally more than female members of the public.

Objective: This 2-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 a 3-month follow-up (day 84) among women who have served in the UKAF.

Methods: In this 2-arm single-blinded RCT, a smartphone app that includes interactive user-focused features tailored toward the needs of female veterans and designed to enhance participants' motivations to reduce the amount of alcohol they consume is compared with the UK Chief Medical Officer guidance on alcohol consumption. The trial will be conducted among women who have served at least 1 day of paid service in the UKAF. Recruitment, consent, and data collection will be carried out automatically through the DrinksRation app or the BeAlcoholSmart platform. The primary outcome is change in self-reported weekly alcohol consumption between baseline (day 0) and the 3-month follow-up (day 84) measured using the Timeline Follow Back for alcohol consumption. The secondary outcome is the change in the Alcohol Use Disorders Identification Test score measured at baseline and 3-month follow-up between the control and intervention groups. The 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 January 2024 and last for 5 months. We aim to complete all data collection, including interviews, by May 2024.

Conclusions: This study will assess whether a smartphone app tailored to the needs of women who have served in the UKAF is efficacious in reducing self-reported alcohol consumption. If successful, the digital therapeutics platform could be used not only to support women who have served in the UKAF but also for other conditions and disorders.

Trial registration: ClinicalTrials.gov NCT05970484; https://www.clinicaltrials.gov/study/NCT05970484.

International registered report identifier (irrid): PRR1-10.2196/51531.

Keywords: Armed Forces; DrinksRation; RCT; United Kingdom; alcohol; alcohol misuse; controlled trials; digital health; digital therapeutic; mHealth; mental health; mobile app; mobile health; mobile phone; randomized controlled trial; smartphone app; study protocol; veterans; woman; women; women veterans.

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Conflict of interest statement

Conflicts of Interest: DM is a trustee of the Forces in Mind Trust and is employed by Combat Stress. NTF sits on the independent group advising on the release of patient data at National Health Service Digital and is also a trustee of a military-related charity. KK and AS are full-time member of the UK Armed Forces. DL is a reservist in the UK Armed Forces; this work has been undertaken as part of his civilian employment. SD is a member of the Office for Veterans’ Affairs (OVA) Academic Advisory Board and sits on the Forces in Mind Trust Mental Health Steering Group. All other authors declare no other conflicts of interest.

Figures

Figure 1
Figure 1
Consent flow screenshot examples presented to all study participants.
Figure 2
Figure 2
Study flow diagram. Primary outcome is assessed at day 84.
Figure 3
Figure 3
Example screenshots of the DrinksRation app.
See this image and copyright information in PMC

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References

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