Mental Health Issue Clinical Trial
— Drinks:RationOfficial 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
Verified date | June 2021 |
Source | King's College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 123 |
Est. completion date | March 28, 2022 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Participants will be excluded if they are listed as being 'red' risk by Combat Stress, which is determined by the clinical team following an initial assessment and is based on a traffic light system to assess risk, where red indicates an immediate high risk to the individual and/or others. The application of 'red' risk is applied independently of the research team and is used only where participation in the study could impact clinical treatment. The exclusion will apply only during contact list data extraction. - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Combat Stress | Leatherhead | Surrey |
Lead Sponsor | Collaborator |
---|---|
King's College London | British Army, Combat Stress, University of Liverpool |
United Kingdom,
Leightley 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. — View 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 Feasib — View 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. — View 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 Control — View 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 — View 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Repeated measure analysis | The Primary Outcome Measure and Secondary Outcome Measures 2 and Secondary Outcome Measures 3 will be reassessed at month 6. The analysis will explore the difference in alcohol unit consumed (continuous), Alcohol Use Disorder Identification Test score (0-40; a score 8 > indicates increased risk) and the World Health Organization Quality of Life-BREF score (unit measure: life years) between baseline, day 28 (1 month), day 84 (3 months) and 6 months (164 days). The analysis will report change between baseline and each timepoints. | 6 months | |
Other | Usage of the Drinks:Ration app | An additional analysis will explore the usage of the app over the first 28 days by participants (in intervention period). This will be reported as the number of app engagements per week (frequency count), the number of pages viewed per week (frequency count) and the number of participants to open the app each week (frequency count - participants). | 28-days | |
Other | Evaluating usability of Drinks:Ration | Participants will be asked to complete the mHealth App Usability Questionnaire at day 28, a 16-item, 7-point Likert scale questionnaire focused on assessing the usability of a smartphone app. Each question is focused on a specific domain, the highest the rating (7=excellent) the more positive the outcome. Participants responses will be aggregated per question, and reported as a mean value. | 28-days | |
Primary | 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 | Change in Alcohol Use Disorder Identification Test score | Exploring the change in baseline (day 0) to follow-up (day 84) Alcohol Use Disorder Identification Test score (range between 0-40; 8 or more indicates increased risk) | 3 months | |
Secondary | Change in Quality of Adjusted Life Years | Exploring change in baseline (day 0) to follow-up (day 84) in World Health Organization Quality of Life-BREF questionnaire to assess Quality of Adjusted Life Years (unit measure: life years) | 3 months |
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