Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 12:55 AM
Study NCT ID:
NCT04494594
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2020-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drinks:Ration - Combat Stress Randomized Controlled Trial
Sponsor:
King's College London
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Drinks:Ration
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.
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.
Detailed Description:
Alcohol misuse is common in the United Kingdom (UK) Armed Forces (AF), with the prevalence rates higher in the AF than the general population. Research indicates that the trend continues after personnel leave service ('veteran' or 'ex-serving' are used interchangeably in the UK). It has been estimated that more than 50% of those who have left the AF meet the criteria for hazardous alcohol use, a score of eight or above on the Alcohol Use Disorders Identification Test (AUDIT).
The last two decades has seen a proliferation in the use of digital technologies to support brief intervention management and treatment of alcohol misuse in the general public, yet little attention has focused forwards the AF community. In the late 1990's interventions were commonly delivered via a computer using CD-ROM-based programmes, but with the advent of the World Wide Web many new opportunities arose to harness increase reach, provide real-time monitoring, and offer personalised treatment. This includes the use of Short Message Service (SMS) which have been shown to be effective in encouraging people to change their behaviour.
The aim of this 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 self-reported weekly alcohol consumption between baseline and 3 months (day 84) 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.
The last two decades has seen a proliferation in the use of digital technologies to support brief intervention management and treatment of alcohol misuse in the general public, yet little attention has focused forwards the AF community. In the late 1990's interventions were commonly delivered via a computer using CD-ROM-based programmes, but with the advent of the World Wide Web many new opportunities arose to harness increase reach, provide real-time monitoring, and offer personalised treatment. This includes the use of Short Message Service (SMS) which have been shown to be effective in encouraging people to change their behaviour.
The aim of this 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 self-reported weekly alcohol consumption between baseline and 3 months (day 84) 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: