Drinks:Ration - Combat Stress Randomized Controlled Trial
Drinks:Ration
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
1 other identifier
interventional
123
1 country
1
Brief Summary
Alcohol misuse is higher in the United Kingdom (UK) Armed Forces (AF) than the general population. Previous research has shown that interventions delivered via smartphone are efficacious in promoting self-monitoring of alcohol use, have utility in reducing alcohol consumption and have a broad reach. The main objective of this participant blinded (single-blinded) Randomised Controlled Trial (RCT) is to assess the efficacy of a 28-day brief alcohol intervention delivered via a smartphone app (Drinks:Ration) in reducing weekly self-reported alcohol consumption between baseline and 3-month follow-up among veterans who drink at a hazardous or harmful level and are receiving, or have received, support for mental health symptoms in a clinical setting. Methods: In a two-arm single-blinded Randomised Controlled Trial (RCT), a smartphone app which includes interactive features designed to enhance participant motivation and personalised messaging is compared to a smartphone app which only provides Government guidance on alcohol consumption. The trial will be conducted in a veteran population who have sought help through Combat Stress; a UK veteran's mental health charity. Recruitment, consent and data collection is performed automatically through the Drinks:Ration platform. The primary outcome is change in self-reported weekly alcohol consumption between baseline (day 0) and 3-month follow-up (day 84) as measured using the Time-Line Follow back for Alcohol Consumption; secondary outcome measures include 1) change in baseline to 3-month follow-up (day 84) Alcohol Use Disorder Identification Test score, and 2) change in baseline to 3-month follow-up (day 84) World Health Organisation Quality of Life-BREF score to assess Quality of Adjusted Life Years. Process evaluation measures include 1) app usage, and 2) usability ratings as measured by the mHealth App Usability Questionnaire. The primary and secondary outcomes will also be re-assessed at 6-month follow-up (day 168) to assess the longer-term benefits of the intervention and reported as a secondary outcome. The study will begin recruitment in September 2020 and is expected to require 12 months to complete. Study results should be published in 2022.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2020
CompletedFirst Posted
Study publicly available on registry
July 31, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2022
CompletedOctober 14, 2022
June 1, 2021
11 months
July 23, 2020
October 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alcohol consumption change
The primary outcome measure is change between self-reported alcohol consumption as measured by the 7-day timeline to Followback over the previous seven days between baseline (day 0) and 3-month follow-up (day 84)
3 months
Secondary Outcomes (2)
Change in Alcohol Use Disorder Identification Test score
3 months
Change in Quality of Adjusted Life Years
3 months
Other Outcomes (3)
Repeated measure analysis
6 months
Usage of the Drinks:Ration app
28-days
Evaluating usability of Drinks:Ration
28-days
Study Arms (2)
Control
SHAM COMPARATORIntervention
ACTIVE COMPARATORInterventions
Drinks:Ration (www.drinksration.app; formerly called InDEx) app has been developed following the Medical Research Council Complex Intervention Guidelines and using co-design methodology by the King's Centre for Military Health Research (at King's College London) and the University of Liverpool, supported by experts in smartphone app development, epidemiology, addiction psychiatry, and military mental health. The app is designed to support veterans drinking at a hazardous or harmful level by providing detailed advice and support over a minimum of 28-day period. The app is theoretically underpinned to enhance participants motivation and self-efficacy in modifying their alcohol consumption by means of Behaviour Change Theory in the content displayed, and the messaging sent to participants.
Eligibility Criteria
You may qualify if:
- Participants will be included if they have downloaded the app onto an iOS or Android device;
- Participants will be included if they are 18 years of age or older;
- Participants will be included if they live in the UK;
- Participants will be included if they consume fourteen units (approximately 140g of alcohol) of alcohol or more per week as measured using Time-Line Follow back for Alcohol Consumption at baseline (day 0);
- Participants will be included if they provide a mobile phone number; and
- Are a veteran of the UK Armed Forces.
You may not qualify if:
- Participants will be excluded if they do not have a mobile phone; and
- Participants will be excluded if they have not given Combat Stress consent for contact for research purposes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King's College Londonlead
- University of Liverpoolcollaborator
- British Armycollaborator
- Combat Stresscollaborator
Study Sites (1)
Combat Stress
Leatherhead, Surrey, KT22 0BX, United Kingdom
Related Publications (7)
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.
PMID: 33006569BACKGROUNDWilliamson 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.
PMID: 35670777BACKGROUNDPuddephatt 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.
PMID: 31127726RESULTLeightley 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.
PMID: 30206054RESULTLeightley D, Puddephatt JA, Goodwin L, Rona R, Fear NT. InDEx: Open Source iOS and Android Software for Self-Reporting and Monitoring of Alcohol Consumption. J Open Res Softw. 2018 Mar 23;6:13. doi: 10.5334/jors.207.
PMID: 29795769RESULTLeightley 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.
PMID: 35724966RESULTTrompeter N, Williamson C, Rona RJ, Carr E, Simms A, Agwuna J, Fear NT, Goodwin L, Murphy D, Shearer J, Leightley D. Shorter communications: Exploring the impact of a brief smartphone-based alcohol intervention app (DrinksRation) on the quality of life of UK military veterans. Behav Res Ther. 2024 Jun;177:104540. doi: 10.1016/j.brat.2024.104540. Epub 2024 Apr 6.
PMID: 38598898DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Randomisation occurs when a quick response (QR) code is generated and a unique proxy identifier and participant gender is assigned. At this point, participants are automatically randomised to receive the control or intervention arm and are blinded. Block randomisation, of size 2, will be used to ensure equal gender distribution across both conditions. The randomisation procedure is done automatically by the Drinks:Ration platform with no human involvement except to provide a proxy identifier and gender.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2020
First Posted
July 31, 2020
Study Start
October 1, 2020
Primary Completion
September 1, 2021
Study Completion
March 28, 2022
Last Updated
October 14, 2022
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- Time Frame
- Data is available for access via contact to the lead researcher.
- Access Criteria
- Researchers will be required to sign a Data Sharing Agreement.
To promote open science, consent will be sought from participants to share their data anonymously for research purposes. This data will be released upon completion of the study. Only questionnaire response, remote measurement technology data and alcohol consumption statistics will be shared. All data will be de-identified, and no personal data will be released.