<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04494594</url>
  </required_header>
  <id_info>
    <org_study_id>HR-19/20-17438</org_study_id>
    <nct_id>NCT04494594</nct_id>
  </id_info>
  <brief_title>Drinks:Ration - Combat Stress Randomized Controlled Trial</brief_title>
  <acronym>Drinks:Ration</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Liverpool</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>British Army</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Combat Stress</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King's College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Alcohol misuse is higher in the United Kingdom (UK) Armed Forces (AF) than the general&#xD;
      population. Previous research has shown that interventions delivered via smartphone are&#xD;
      efficacious in promoting self-monitoring of alcohol use, have utility in reducing alcohol&#xD;
      consumption and have a broad reach. The main objective of this participant blinded&#xD;
      (single-blinded) Randomised Controlled Trial (RCT) is to assess the efficacy of a 28-day&#xD;
      brief alcohol intervention delivered via a smartphone app (Drinks:Ration) in reducing weekly&#xD;
      self-reported alcohol consumption between baseline and 3-month follow-up among veterans who&#xD;
      drink at a hazardous or harmful level and are receiving, or have received, support for mental&#xD;
      health symptoms in a clinical setting.&#xD;
&#xD;
      Methods: In a two-arm single-blinded Randomised Controlled Trial (RCT), a smartphone app&#xD;
      which includes interactive features designed to enhance participant motivation and&#xD;
      personalised messaging is compared to a smartphone app which only provides Government&#xD;
      guidance on alcohol consumption. The trial will be conducted in a veteran population who have&#xD;
      sought help through Combat Stress; a UK veteran's mental health charity. Recruitment, consent&#xD;
      and data collection is performed automatically through the Drinks:Ration platform. The&#xD;
      primary outcome is change in self-reported weekly alcohol consumption between baseline (day&#xD;
      0) and 3-month follow-up (day 84) as measured using the Time-Line Follow back for Alcohol&#xD;
      Consumption; secondary outcome measures include 1) change in baseline to 3-month follow-up&#xD;
      (day 84) Alcohol Use Disorder Identification Test score, and 2) change in baseline to 3-month&#xD;
      follow-up (day 84) World Health Organisation Quality of Life-BREF score to assess Quality of&#xD;
      Adjusted Life Years. Process evaluation measures include 1) app usage, and 2) usability&#xD;
      ratings as measured by the mHealth App Usability Questionnaire. The primary and secondary&#xD;
      outcomes will also be re-assessed at 6-month follow-up (day 168) to assess the longer-term&#xD;
      benefits of the intervention and reported as a secondary outcome. The study will begin&#xD;
      recruitment in September 2020 and is expected to require 12 months to complete. Study results&#xD;
      should be published in 2022.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alcohol misuse is common in the United Kingdom (UK) Armed Forces (AF), with the prevalence&#xD;
      rates higher in the AF than the general population. Research indicates that the trend&#xD;
      continues after personnel leave service ('veteran' or 'ex-serving' are used interchangeably&#xD;
      in the UK). It has been estimated that more than 50% of those who have left the AF meet the&#xD;
      criteria for hazardous alcohol use, a score of eight or above on the Alcohol Use Disorders&#xD;
      Identification Test (AUDIT).&#xD;
&#xD;
      The last two decades has seen a proliferation in the use of digital technologies to support&#xD;
      brief intervention management and treatment of alcohol misuse in the general public, yet&#xD;
      little attention has focused forwards the AF community. In the late 1990's interventions were&#xD;
      commonly delivered via a computer using CD-ROM-based programmes, but with the advent of the&#xD;
      World Wide Web many new opportunities arose to harness increase reach, provide real-time&#xD;
      monitoring, and offer personalised treatment. This includes the use of Short Message Service&#xD;
      (SMS) which have been shown to be effective in encouraging people to change their behaviour.&#xD;
&#xD;
      The aim of this Randomised Controlled Trial (RCT) is to assess the efficacy of a 28-day brief&#xD;
      alcohol intervention delivered via a smartphone app (Drinks:Ration) in reducing self-reported&#xD;
      weekly alcohol consumption between baseline and 3 months (day 84) among veterans who drink at&#xD;
      a hazardous or harmful level and are receiving, or have received, support for mental health&#xD;
      symptoms in a clinical setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">March 28, 2022</completion_date>
  <primary_completion_date type="Actual">September 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a two-arm participant blinded (single-blinded) RCT, comparing a smartphone app (control arm) which includes feedback on baseline self-reported alcohol consumption, with a smartphone app (intervention arm) that includes individualised normative feedback, plus features designed to enhance participant motivation, app interactive feedback and self-efficacy in modifying their alcohol consumption. In this study, both the control and intervention arms will be delivered via one smartphone app known as Drinks:Ration. Participants in the control arm are given access only to alcohol consumption feedback based on publicly available health guidance and reminder messaging to consult the feedback. Those in the intervention arm are given full access to the app which includes all theoretically driven components and messaging (discussed further in Intervention section). Both arms will be asked to use the app for 28-days.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Alcohol consumption change</measure>
    <time_frame>3 months</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Alcohol Use Disorder Identification Test score</measure>
    <time_frame>3 months</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Adjusted Life Years</measure>
    <time_frame>3 months</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Repeated measure analysis</measure>
    <time_frame>6 months</time_frame>
    <description>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 &gt; 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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Usage of the Drinks:Ration app</measure>
    <time_frame>28-days</time_frame>
    <description>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).</description>
  </other_outcome>
  <other_outcome>
    <measure>Evaluating usability of Drinks:Ration</measure>
    <time_frame>28-days</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">123</enrollment>
  <condition>Alcohol Abuse</condition>
  <condition>Mental Disorder</condition>
  <condition>Mental Health Issue</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Drinks:Ration app</intervention_name>
    <description>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.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants will be included if they have downloaded the app onto an iOS or Android&#xD;
             device;&#xD;
&#xD;
          -  Participants will be included if they are 18 years of age or older;&#xD;
&#xD;
          -  Participants will be included if they live in the UK;&#xD;
&#xD;
          -  Participants will be included if they consume fourteen units (approximately 140g of&#xD;
             alcohol) of alcohol or more per week as measured using Time-Line Follow back for&#xD;
             Alcohol Consumption at baseline (day 0);&#xD;
&#xD;
          -  Participants will be included if they provide a mobile phone number; and&#xD;
&#xD;
          -  Are a veteran of the UK Armed Forces.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants will be excluded if they are listed as being 'red' risk by Combat Stress,&#xD;
             which is determined by the clinical team following an initial assessment and is based&#xD;
             on a traffic light system to assess risk, where red indicates an immediate high risk&#xD;
             to the individual and/or others. The application of 'red' risk is applied&#xD;
             independently of the research team and is used only where participation in the study&#xD;
             could impact clinical treatment. The exclusion will apply only during contact list&#xD;
             data extraction.&#xD;
&#xD;
          -  Participants will be excluded if they do not have a mobile phone; and&#xD;
&#xD;
          -  Participants will be excluded if they have not given Combat Stress consent for contact&#xD;
             for research purposes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Combat Stress</name>
      <address>
        <city>Leatherhead</city>
        <state>Surrey</state>
        <zip>KT22 0BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://drinksration.app/</url>
    <description>Drinks:Ration website</description>
  </link>
  <reference>
    <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>
    <PMID>33006569</PMID>
  </reference>
  <reference>
    <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>
    <PMID>35670777</PMID>
  </reference>
  <results_reference>
    <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>
    <PMID>31127726</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>30206054</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>29795769</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>35724966</PMID>
  </results_reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>October 11, 2022</last_update_submitted>
  <last_update_submitted_qc>October 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>alcohol</keyword>
  <keyword>mobile health</keyword>
  <keyword>sms text message</keyword>
  <keyword>push notifications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>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.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data is available for access via contact to the lead researcher.</ipd_time_frame>
    <ipd_access_criteria>Researchers will be required to sign a Data Sharing Agreement.</ipd_access_criteria>
    <ipd_url>https://drinksration.app/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04494594
org study id: HR-19/20-17438
nct id: NCT04494594
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a two-arm participant blinded (single-blinded) RCT, comparing a smartphone app (control arm) which includes feedback on baseline self-reported alcohol consumption, with a smartphone app (intervention arm) that includes individualised normative feedback, plus features designed to enhance participant motivation, app interactive feedback and self-efficacy in modifying their alcohol consumption. In this study, both the control and intervention arms will be delivered via one smartphone app known as Drinks:Ration. Participants in the control arm are given access only to alcohol consumption feedback based on publicly available health guidance and reminder messaging to consult the feedback. Those in the intervention arm are given full access to the app which includes all theoretically driven components and messaging (discussed further in Intervention section). Both arms will be asked to use the app for 28-days.
primary purpose: Treatment
masking: Double (Participant, Care Provider)
masking description: 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.
measure: Alcohol consumption change
time frame: 3 months
description: 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)
measure: Change in Alcohol Use Disorder Identification Test score
time frame: 3 months
description: 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)
measure: Change in Quality of Adjusted Life Years
time frame: 3 months
description: 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)
measure: Repeated measure analysis
time frame: 6 months
description: 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.
measure: Usage of the Drinks:Ration app
time frame: 28-days
description: 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).
measure: Evaluating usability of Drinks:Ration
time frame: 28-days
description: 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.
arm group label: Control
arm group type: Sham Comparator
arm group label: Intervention
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Drinks:Ration app
description: 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.
arm group label: Control
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
url: https://drinksration.app/
description: Drinks:Ration website
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.
PMID: 33006569
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.
PMID: 35670777
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.
PMID: 31127726
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.
PMID: 30206054
citation: 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.
PMID: 29795769
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.
PMID: 35724966
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Mental Disorders
sharing ipd: Yes
ipd description: 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.
ipd info type: Study Protocol
ipd info type: Analytic Code
ipd time frame: Data is available for access via contact to the lead researcher.
ipd access criteria: Researchers will be required to sign a Data Sharing Agreement.
ipd url: https://drinksration.app/