xml: <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/NCT05970484</url>
    </required_header>
    <id_info>
      <org_study_id>LRS/DP-22/23-36879</org_study_id>
      <nct_id>NCT05970484</nct_id>
    </id_info>
    <brief_title>Supporting Women in the UK Armed Forces Who Consume Alcohol at an Increased Risk: Refining the DrinksRation Platform</brief_title>
    <acronym>RationW</acronym>
    <official_title>Supporting Women in the UK Armed Forces Who Consume Alcohol at an Increased Risk: Refining the DrinksRation Platform - Study Protocol</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>King's College London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Lancaster University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Combat Stress</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Swansea University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>UK British Army</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>King's College London</source>
    <oversight_info>
      <has_dmc>Yes</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 common in the Armed Forces (AF), with prevalence higher than in the general&#xD;
        population. To date, initiatives to support alcohol misuse have focused on males, who&#xD;
        represent ~90% of the AF. However, female veterans drink disproportionally more than female&#xD;
        members of the public. In this study, we will refine and evaluate DrinksRation - the only&#xD;
        automated brief digital intervention supporting the United Kingdom (UK) Armed Forces to&#xD;
        manage and reduce the amount they drink - to tailor the intervention to the specific needs of&#xD;
        female veterans. The changes will then be assessed using a confirmatory Randomized Controlled&#xD;
        Trial (RCT), which includes a minimum of 148 (74 in each arm) female veterans (to be&#xD;
        recruited).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        There are 2.5 million AF veterans in the UK (defined by the British Government as those who&#xD;
        have served in the military for at least one paid day), of which 11% are estimated to&#xD;
        identify as female. Female veterans have served within the AF for over 100 years. While their&#xD;
        valuable contribution has been recognized, military culture, together with evolving Service&#xD;
        requirements, have had a significant impact on the health and well-being of many. Yet, there&#xD;
        is a dearth of evidence on the impact of alcohol use on female veteran health.&#xD;
  &#xD;
        The limited existing evidence suggests that female veterans' alcohol use is increasing and&#xD;
        that they are significantly more likely to report symptoms of hazardous drinking when&#xD;
        compared with female civilians. Increased rates of hazardous drinking were also observed by&#xD;
        Palmer and colleagues (202), who found that half (49%; n=389 of 779 female veterans) were&#xD;
        misusing alcohol at a hazardous or higher level which is considered harmful to their health.&#xD;
        To place this into context, the UK Chief Medical Officer recommends that everyone does not&#xD;
        regularly drink more than 14 units per week, to keep health risks from drinking alcohol to a&#xD;
        low level.&#xD;
  &#xD;
        Alcohol misuse often co-occurs with common mental health disorders including PTSD, anxiety,&#xD;
        or depression, and alcohol is frequently used as a coping mechanism. Common mental health&#xD;
        disorders are more common in females than male veterans. Research has also shown that female&#xD;
        veterans face barriers to accessing mental health support, often due to misusing alcohol.&#xD;
        Ultimately, while female veterans drink less than male veterans, their rates of hazardous&#xD;
        drinking are higher than the general population putting them at increased risk of poorer&#xD;
        health.&#xD;
  &#xD;
        The impact of alcohol misuse among female veterans on the wider society (e.g. health care&#xD;
        utilization, productivity, and welfare) is unknown. In England, heavy drinking (deemed as&#xD;
        drinking more than 14 units of alcohol per week) is estimated to cost the National Health&#xD;
        Service (NHS) £3.5 billion per year (3.6% of its annual budget) and is more common in people&#xD;
        with mental health difficulties, Since female veterans drink more than their civilian&#xD;
        counterparts, the relative costs are likely to be even higher. Innovative solutions are&#xD;
        urgently required.&#xD;
  &#xD;
        In recent years there has been a growing treatment gap in the UK, with patients waiting&#xD;
        longer for treatment and support for alcohol misuse. To overcome this gap, we developed the&#xD;
        DrinksRation platform (www.drinksration.app), an automated brief digital intervention&#xD;
        designed to support help-seeking veterans in managing and reducing the amount they drink.&#xD;
        DrinksRation is unique in that the app content is tailored using behaviour change techniques&#xD;
        to promote positive changes in behaviour. DrinksRation is the only app targeting alcohol&#xD;
        misuse in the UK AF. It is designed to (1) overcome geographical limitations; (2) use&#xD;
        wearable technology (e.g. Fitbit, Apple Watch) to inform decision-making and personalization;&#xD;
        (3) avoid the stigma associated with receiving help in person; and (4) provide convenience&#xD;
        since users can use the app as they prefer (discretely or openly). The app is freely&#xD;
        available via Apple and Google App stores. The app has received support and endorsement from&#xD;
        Combat Stress and is currently being trialled in serving personnel. DrinksRation is supported&#xD;
        by a robust evidence base, including a randomized controlled trial which demonstrated that&#xD;
        the app is efficacious in reducing alcohol consumption.&#xD;
  &#xD;
        The DrinksRation app was developed to support veterans who have sought help for a mental&#xD;
        health problem and was not designed with potential gender differences in mind. A recent&#xD;
        viewpoint highlighted a critical need for feminist intersectionality in digital health to&#xD;
        incorporate the unique needs of females. Digital health technologies can bolster gender&#xD;
        equality through increased access to healthcare, empowerment of one's health data, overcoming&#xD;
        the specific barriers facing female veterans, and reducing the burden on healthcare systems.&#xD;
  &#xD;
        This project aims to tailor the DrinksRation app to reflect the specific needs of female&#xD;
        veterans and evaluate these changes using a confirmatory randomized controlled trial. It is&#xD;
        hypothesized that a refined version of DrinksRation will be efficacious at reducing&#xD;
        self-reported weekly alcohol consumption between baseline and 3-month follow-up (day 84)&#xD;
        among female veterans who drink at a hazardous or harmful level.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</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) 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.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Researcher DL and GW will be unblinded to treatment allocation to enable the management of the BeAlcoholSmart and DrinksRation platforms and participant recruitment and retention; researcher EC will be unblinded to treatment allocation to prepare statistical reports. Researcher DL and EC will not be involved in participant engagement. All other members of the study team will be blind to treatment allocation.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Alcohol Use 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>AUDIT Score Change</measure>
      <time_frame>3 months</time_frame>
      <description>change in AUDIT score, measured at baseline (day 0) and day 84 follow-up between the control and intervention groups</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">148</enrollment>
    <condition>Alcohol Abuse</condition>
    <condition>Alcohol Drinking</condition>
    <condition>Alcohol Use Disorder</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Use of the DrinksRation app with all functionality</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Use of the BeAlcoholSmart app with all functionality</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>DrinksRation</intervention_name>
      <description>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.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>BeAlcoholSmart</intervention_name>
      <description>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.</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria&#xD;
  &#xD;
            -  Are aged 18 years or older;&#xD;
  &#xD;
            -  Identify as female (self-reported sex);&#xD;
  &#xD;
            -  Live in the United Kingdom;&#xD;
  &#xD;
            -  Consume 15 UK units (approximately 150g) of alcohol or more per week as measured using&#xD;
               Timeline Follow-back for alcohol consumption (TLFB; [23]) at baseline (day 0);&#xD;
  &#xD;
            -  Are veterans of the UK AF, defined as per UK definitions as having completed at least&#xD;
               one day of paid employment in the UK AF (verified by self-report at eligibility&#xD;
               screening);&#xD;
  &#xD;
            -  Have downloaded the mobile app onto an iOS or Android smartphone.&#xD;
  &#xD;
          Exclusion criteria&#xD;
  &#xD;
          -Does not own a smartphone phone.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Identify as female (self-reported sex);</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>King's Centre for Military Health Research</name>
        <address>
          <city>London</city>
          <zip>SE9 5RJ</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <link>
      <url>http://www.drinksration.app</url>
      <description>Related Info</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>
    <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>
    </reference>
    <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>
    </reference>
    <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>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>digital health</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alcoholism</mesh_term>
      <mesh_term>Alcohol Drinking</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>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.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Upon publication of the main study report.</ipd_time_frame>
      <ipd_access_criteria>None required.</ipd_access_criteria>
      <ipd_url>http://drinksration.app</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970484
  org study id: LRS/DP-22/23-36879
  nct id: NCT05970484
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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, we 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).
  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, we 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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention 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.
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: Researcher DL and GW will be unblinded to treatment allocation to enable the management of the BeAlcoholSmart and DrinksRation platforms and participant recruitment and retention; researcher EC will be unblinded to treatment allocation to prepare statistical reports. Researcher DL and EC will not be involved in participant engagement. All other members of the study team will be blind to treatment allocation.
  measure: Alcohol Use 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: AUDIT Score Change
  time frame: 3 months
  description: change in AUDIT score, measured at baseline (day 0) and day 84 follow-up between the control and intervention groups
  arm group label: Intervention
  arm group type: Experimental
  description: Use of the DrinksRation app with all functionality
  arm group label: Control
  arm group type: Active Comparator
  description: Use of the BeAlcoholSmart app with all functionality
  intervention type: Behavioral
  intervention name: DrinksRation
  description: 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.
  arm group label: Intervention
  intervention type: Behavioral
  intervention name: BeAlcoholSmart
  description: 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.
  arm group label: Control
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Identify as female (self-reported sex);
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: United Kingdom
  url: http://www.drinksration.app
  description: Related Info
  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, 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: Alcohol Drinking
  sharing ipd: Yes
  ipd description: 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.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Upon publication of the main study report.
  ipd access criteria: None required.
  ipd url: http://drinksration.app