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Alcohol AbuseRationWNCT05970484

Supporting Women in the UK Armed Forces Who Consume Alcohol at an Increased Risk: Refining the DrinksRation Platform

A study testing DrinksRation and BeAlcoholSmart in people with Alcohol Abuse and Alcohol Drinking, run by King's College London at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
DrinksRation and BeAlcoholSmart
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
1 siteUnited Kingdom
Study dates
1 Sep 2023to 31 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • -Does not own a smartphone phone.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site, 1 recruiting
  • King's Centre for Military Health Research

    London, SE9 5RJ

    Daniel Leightley, PhD, daniel.leightley@kcl.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: Supporting Women in the UK Armed Forces Who Consume Alcohol at an Increased Risk: Refining the DrinksRation Platform - Study Protocol

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).

Read the 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.

Being tested
DrinksRation, BeAlcoholSmart
Keywords
digital health
Medical subject headings
Alcoholism, Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DrinksRationBehavioural

    DrinksRation (www.drinksration.app; formerly called InDEx) app was developed following the Medical Research Council Complex Intervention Guidelines and using a co-design methodology. It was developed by the King's Centre for Military Health Research (King's College London) and Lancaster University, supported by experts in smartphone app development, epidemiology, addiction psychiatry, and military mental health. The app was designed to support veterans drinking at a hazardous or harmful level by providing bespoke advice and support.

  • BeAlcoholSmartBehavioural

    BeAlcoholSmart is a progressive web app (PWA). The app can take advantage of smartphone features such as push notifications and haptics without requiring the participant to download via an app store. The app will contain a 7-day alcohol unit calculator and generic public health guidance on safe drinking. Participants will also receive reminders via email prompting them to consult the guidance as part of the BeAlcoholSmart. Control participant participants will be invited to complete all questionnaires via Qualtrics, with an email reminder being sent when they are due.

Study groups in NCT05970484
Study groupRoleWhat they receive
InterventionExperimentalUse of the DrinksRation app with all functionality
Receives: Behavioral: DrinksRation
ControlActive comparatorUse of the BeAlcoholSmart app with all functionality
Receives: Behavioral: BeAlcoholSmart

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alcohol Use Change

    The primary outcome measure is change between self-reported alcohol consumption as measured by the alcohol use 7-day timeline over the previous seven days between baseline (day 0) and 3-month follow-up (day 84). Outcome is reported as number of units, with a higher number of units indicating poorer outcome.

    Measured: 3 months

Secondary outcomes (1)
  1. Change in Alcohol use disorders identification test (AUDIT)

    Changes in Alcohol Use Disorder Identification Test (AUDIT) score, measured at baseline (day 0) and day 84 follow-up between the control and intervention groups will be assessed. The AUDIT scale ranges from 0 to 40, with a higher scoring indicting poorer outcomes (ie. Higher scores means increased alcohol abuse).

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start1 Sep 2023
  3. Primary completion31 Mar 2024 (estimated)
  4. Study completion31 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05970484
Sponsor's protocol ID
LRS/DP-22/23-36879
Acronym
RationW
Status last verified
Oct 2023
First submitted
24 Jul 2023
Last updated
10 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All study data will be made available in an anonymized format alongside any source code via the Open Science Framework. There are no contractual agreements that limit access or sharing of data.

Publications

  • 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.

    PubMed 33006569
  • 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.

    PubMed 35670777
  • 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.

    PubMed 31127726
  • 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.

    PubMed 30206054
  • 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.

    PubMed 35724966
  • 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 Dec 19;12:e51531. doi: 10.2196/51531.

    PubMed 38113103

Questions about this trial

What is this clinical trial studying?

A study testing DrinksRation and BeAlcoholSmart in people with Alcohol Abuse and Alcohol Drinking, run by King's College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alcohol Use Change (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05970484, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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