Clinical trial NCT05970484: Supporting Women in the UK Armed Forces Who Consume Alcohol at an Increased Risk: Refining the DrinksRation Platform
Official title: Supporting Women in the UK Armed Forces Who Consume Alcohol at an Increased Risk: Refining the DrinksRation Platform - Study Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Abuse
Alcohol Drinking
Alcohol Use Disorder
Keywords: digital health
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Lancaster University
name: Combat Stress
name: Swansea University
name: UK British Army
First posted: 2023-08-01
Enrollment: 148
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm participant-blinded (single-blinded) confirmatory randomized controlled trial (RCT), comparing (intervention arm) the DrinksRation smartphone app with (control arm) a progressive web application (PWA) presenting NHS-focused drinking advice (named 'BeAlcoholSmart'). The DrinksRation app provides individualized normative advice with features designed to enhance participant motivation, interactive feedback, self-efficacy in modifying their alcohol consumption, and personalized gender-specific messaging. We hypothesize that the intervention arm will be efficacious in reducing alcohol consumption compared with the control arm.
Primary purpose: TREATMENT

Brief summary: Alcohol misuse is common in the Armed Forces (AF), with prevalence higher than in the general population. To date, initiatives to support alcohol misuse have focused on males, who represent \~90% of the AF. However, female veterans drink disproportionally more than female members of the public. In this study, the investigators will refine and evaluate DrinksRation - the only automated brief digital intervention supporting the United Kingdom (UK) Armed Forces to manage and reduce the amount they drink - to tailor the intervention to the specific needs of female veterans. The changes will then be assessed using a confirmatory Randomized Controlled Trial (RCT), which includes a minimum of 148 (74 in each arm) female veterans (to be recruited).

Detailed description: There are 2.5 million AF veterans in the UK (defined by the British Government as those who have served in the military for at least one paid day), of which 11% are estimated to identify as female. Female veterans have served within the AF for over 100 years. While their valuable contribution has been recognized, military culture, together with evolving Service requirements, have had a significant impact on the health and well-being of many. Yet, there is a dearth of evidence on the impact of alcohol use on female veteran health.

The limited existing evidence suggests that female veterans' alcohol use is increasing and that they are significantly more likely to report symptoms of hazardous drinking when compared with female civilians. Increased rates of hazardous drinking were also observed by Palmer and colleagues (202), who found that half (49%; n=389 of 779 female veterans) were misusing alcohol at a hazardous or higher level which is considered harmful to their health. To place this into context, the UK Chief Medical Officer recommends that everyone does not regularly drink more than 14 units per week, to keep health risks from drinking alcohol to a low level.

Alcohol misuse often co-occurs with common mental health disorders including PTSD, anxiety, or depression, and alcohol is frequently used as a coping mechanism. Common mental health disorders are more common in females than male veterans. Research has also shown that female veterans face barriers to accessing mental health support, often due to misusing alcohol. Ultimately, while female veterans drink less than male veterans, their rates of hazardous drinking are higher than the general population putting them at increased risk of poorer health.

The impact of alcohol misuse among female veterans on the wider society (e.g. health care utilization, productivity, and welfare) is unknown. In England, heavy drinking (deemed as drinking more than 14 units of alcohol per week) is estimated to cost the National Health Service (NHS) £3.5 billion per year (3.6% of its annual budget) and is more common in people with mental health difficulties, Since female veterans drink more than their civilian counterparts, the relative costs are likely to be even higher. Innovative solutions are urgently required.

In recent years there has been a growing treatment gap in the UK, with patients waiting longer for treatment and support for alcohol misuse. To overcome this gap, the investigators developed the DrinksRation platform (www.drinksration.app), an automated brief digital intervention designed to support help-seeking veterans in managing and reducing the amount they drink. DrinksRation is unique in that the app content is tailored using behaviour change techniques to promote positive changes in behaviour. DrinksRation is the only app targeting alcohol misuse in the UK AF. It is designed to (1) overcome geographical limitations; (2) use wearable technology (e.g. Fitbit, Apple Watch) to inform decision-making and personalization; (3) avoid the stigma associated with receiving help in person; and (4) provide convenience since users can use the app as they prefer (discretely or openly). The app is freely available via Apple and Google App stores. The app has received support and endorsement from Combat Stress and is currently being trialled in serving personnel. DrinksRation is supported by a robust evidence base, including a randomized controlled trial which demonstrated that the app is efficacious in reducing alcohol consumption.

The DrinksRation app was developed to support veterans who have sought help for a mental health problem and was not designed with potential gender differences in mind. A recent viewpoint highlighted a critical need for feminist intersectionality in digital health to incorporate the unique needs of females. Digital health technologies can bolster gender equality through increased access to healthcare, empowerment of one's health data, overcoming the specific barriers facing female veterans, and reducing the burden on healthcare systems.

This project aims to tailor the DrinksRation app to reflect the specific needs of female veterans and evaluate these changes using a confirmatory randomized controlled trial. It is hypothesized that a refined version of DrinksRation will be efficacious at reducing self-reported weekly alcohol consumption between baseline and 3-month follow-up (day 84) among female veterans who drink at a hazardous or harmful level.

Eligibility criteria: Inclusion criteria

* Are aged 18 years or older;
* Identify as female (self-reported sex);
* Live in the United Kingdom;
* Consume 15 UK units (approximately 150g) of alcohol or more per week as measured using Timeline Follow-back for alcohol consumption (TLFB; \[23\]) at baseline (day 0);
* Are veterans of the UK AF, defined as per UK definitions as having completed at least one day of paid employment in the UK AF (verified by self-report at eligibility screening);
* Have downloaded the mobile app onto an iOS or Android smartphone.

Exclusion criteria

-Does not own a smartphone phone.

Primary outcomes:
measure: Alcohol Use Change
timeFrame: 3 months
Secondary outcomes:
measure: Change in Alcohol use disorders identification test (AUDIT)
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's Centre for Military Health Research
Study officials:
References:
citation: Leightley D, Rona RJ, Shearer J, Williamson C, Gunasinghe C, Simms A, Fear NT, Goodwin L, Murphy D. Evaluating the Efficacy of a Mobile App (Drinks:Ration) and Personalized Text and Push Messaging to Reduce Alcohol Consumption in a Veteran Population: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Oct 2;9(10):e19720. doi: 10.2196/19720.
citation: Williamson C, White K, Rona RJ, Simms A, Fear NT, Goodwin L, Murphy D, Leightley D. Smartphone-based alcohol interventions: A systematic review on the role of notifications in changing behaviors toward alcohol. Subst Abus. 2022;43(1):1231-1244. doi: 10.1080/08897077.2022.2074595.
citation: Puddephatt JA, Leightley D, Palmer L, Jones N, Mahmoodi T, Drummond C, Rona RJ, Fear NT, Field M, Goodwin L. A Qualitative Evaluation of the Acceptability of a Tailored Smartphone Alcohol Intervention for a Military Population: Information About Drinking for Ex-Serving Personnel (InDEx) App. JMIR Mhealth Uhealth. 2019 May 24;7(5):e12267. doi: 10.2196/12267.
citation: Leightley D, Puddephatt JA, Jones N, Mahmoodi T, Chui Z, Field M, Drummond C, Rona RJ, Fear NT, Goodwin L. A Smartphone App and Personalized Text Messaging Framework (InDEx) to Monitor and Reduce Alcohol Use in Ex-Serving Personnel: Development and Feasibility Study. JMIR Mhealth Uhealth. 2018 Sep 11;6(9):e10074. doi: 10.2196/10074.
citation: Leightley D, Williamson C, Rona RJ, Carr E, Shearer J, Davis JP, Simms A, Fear NT, Goodwin L, Murphy D. Evaluating the Efficacy of the Drinks:Ration Mobile App to Reduce Alcohol Consumption in a Help-Seeking Military Veteran Population: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Jun 20;10(6):e38991. doi: 10.2196/38991.