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/NCT05993676</url>
    </required_header>
    <id_info>
      <org_study_id>583696</org_study_id>
      <secondary_id>DPRF-19/20-11079</secondary_id>
      <secondary_id>1074/MODREC/20</secondary_id>
      <nct_id>NCT05993676</nct_id>
    </id_info>
    <brief_title>MeT4VeT: Mental Health Toolkit for Military Veterans Trial</brief_title>
    <official_title>A Feasibility Trial of a Smartphone App to Support the Mental Health of UK Armed Forces Veterans (MeT4VeT)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>King's College London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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>
        The proposed research involves the running of a feasibility trial to assess a smart phone app&#xD;
        designed to support military veterans (as they transition out of the Armed Forces)&#xD;
        experiencing mental health difficulties to monitor and manage their mental health,&#xD;
        encouraging them to seek formal mental healthcare services if required. The trial will&#xD;
        compare participants who are provided with the 'full' app (case group) with participants who&#xD;
        receive a 'signposting only' feature free smartphone app, receiving the 'full' app 3months&#xD;
        later once the research trial is over (control group).&#xD;
  &#xD;
        The feasibility trial has two core aims:&#xD;
  &#xD;
          1. To provide initial assessment of the practicality of testing the app Running of the&#xD;
             feasibility trial will provide key information on the practical delivery of the app and&#xD;
             measurement processes; enable an estimation of recruitment and retention of&#xD;
             participants; as well as trialling a series of outcome measures. All participants taking&#xD;
             part in the trial will be asked to complete a short (20minute) in app survey at three&#xD;
             time points: baseline; baseline plus 1month; baseline plus 3months. This questionnaire&#xD;
             will collect demographic information and employ a number of well-being and quality of&#xD;
             life measures.&#xD;
  &#xD;
          2. To provide initial feedback on the app The trial will qualitatively evaluate how those&#xD;
             in the case group use the 'full' app (via collection of app usage data over a 1month&#xD;
             trial period) and how easy to interact with, and potentially helpful, they consider the&#xD;
             app might be (via a short 30minute telephone interview at the end of the 1month app&#xD;
             trial period).&#xD;
  &#xD;
        If the trial indicates that the app is acceptable and feasible then a full randomized control&#xD;
        trial (subject to funding) will be run to assess the effectiveness of the app in supporting&#xD;
        mental health. If proven acceptable then the app would be made freely available to all.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In line with the Medical Research Council Complex Intervention Framework (Medical Research&#xD;
        Council) the feasibility stage of developing an intervention is focused on three areas to&#xD;
        assess the practical aspects of testing an intervention including:&#xD;
  &#xD;
          -  Testing procedures (technical app delivery; measurement processes)&#xD;
  &#xD;
          -  Estimating recruitment and retention (number of eligible/ interested participants;&#xD;
             drop-out rates)&#xD;
  &#xD;
          -  Determining sample size (testing main outcome measures to determine appropriate sample&#xD;
             size for a later randomised control trial)&#xD;
  &#xD;
        In addition to this, the feasibility trial will provide feedback from participants on their&#xD;
        reactions to the app including:&#xD;
  &#xD;
          -  Actual use of the app&#xD;
  &#xD;
          -  Satisfaction with the app&#xD;
  &#xD;
          -  How appropriate they believe the app to be&#xD;
  &#xD;
          -  Intent for continued use&#xD;
  &#xD;
        This toolkit will provide those who participate in the research with an additional support&#xD;
        tool which may help them to manage their own mental health during a potentially challenging&#xD;
        period (as they transition out of the Armed Forces) and help them to identify a need for more&#xD;
        formal support if required.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 15, 2021</start_date>
    <completion_date type="Actual">December 5, 2022</completion_date>
    <primary_completion_date type="Actual">December 5, 2022</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment and retention: Number of interested participants</measure>
      <time_frame>5month recruitment period</time_frame>
      <description>Calculate the total number of participants contacting the study team to express an interest in taking part in the study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recruitment and retention: Number of eligible participants</measure>
      <time_frame>5month recruitment period</time_frame>
      <description>Calculate the total number of participants contacting the study team to express an interest in taking part in the study who are eligible to take part. Calculate this as a percentage of total number of interested participants.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recruitment and retention: Response rate</measure>
      <time_frame>5month recruitment period</time_frame>
      <description>Calculate the total number of eligible participants who went onto complete the consent form. Calculate this as a percentage of total number of eligible participants.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recruitment and retention: One month follow up retention rates</measure>
      <time_frame>Baseline plus 1 months (28 days), end of trial period</time_frame>
      <description>Calculate the total number of participants enrolled onto the study who went onto complete the 1month follow up. Calculate this as a percentage of total number of enrolled participants.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recruitment and retention 4: Three month follow up retention rates</measure>
      <time_frame>Baseline plus 3 months (84 days)</time_frame>
      <description>Calculate the total number of participants enrolled onto the study who went onto complete the 3month follow up. Calculate this as a percentage of total number of enrolled participants.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recruitment and retention 5: Comparability of sample to MOD personnel</measure>
      <time_frame>Baseline plus 3 months (84 days)</time_frame>
      <description>Comparability of sample to Ministry of Defence statistics for major sub-groups of veterans (age, service branch, rank)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Trial procedures and outcome measures: Technical delivery</measure>
      <time_frame>Baseline plus 1 months (28 days), end of trial period</time_frame>
      <description>Evaluation of the technical delivery of the app was gained through gathering feedback from developers and participants, identifying any potential technical issues</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Trial procedures and outcome measures: GHQ12</measure>
      <time_frame>Baseline plus 3 months (84 days)</time_frame>
      <description>The General Health Questionnaire (GHQ-12) is a measure of common mental disorders such as anxiety and depression. It is a 12-item self-report questionnaire measured on a 4-point scale. Scores range from 0-12 with a score of 4 or more indicative of probable mental ill health.The difference between scores at baseline, day 28 (1month) and day 84 (3months) were calculated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Trial procedures and outcome measures: PCL-C</measure>
      <time_frame>Baseline plus 3 months (84 days)</time_frame>
      <description>To evaluate symptoms of PTSD, the PTSD Checklist Civilian version (PCL-C) was used. It is a 17-item self-report questionnaire, measured on a 5-point scale from (1) not at all to (5) extremely. Scores range from 17 to 85, scores over 50 are indicative of possible PTSD. The difference between scores at baseline, day 28 (1month) and day 84 (3months) were calculated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Trial procedures and outcome measures: Well-being</measure>
      <time_frame>Baseline plus 3 months (84 days)</time_frame>
      <description>Warwick Edinburgh Mental Well-being Scale (WEMWBS) measures mental well-being within the previous two weeks and is a 14-item self-report questionnaire measured on a 5-point scale from (1) none of the time to (5) all of the time. Scores range from 14 to 70 with higher scores indicative of greater mental well being. The difference between scores at baseline, day 28 (1month) and day 84 (3months) were calculated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Trial procedures and outcome measures: WHO QOL-BREF</measure>
      <time_frame>Baseline plus 3 months (84 days)</time_frame>
      <description>Quality of life was assessed using the World Health Organization Quality of Life Assessment (WHOQOL-BREF), a 26-item self-report questionnaire divided into four domains: physical health; social relationships; psychological health; environmental health. It is measured on a 5-point scale, with a score of 0-100 calculated, where 100 equates to the best possible state of health. The difference between scores at baseline, day 28 (1month) and day 84 (3months) were calculated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Trial procedures and outcome measures: Completion rates</measure>
      <time_frame>Baseline plus 3 months (84 days)</time_frame>
      <description>Examination of the feasibility of using the app to collection outcome measures was assessed via completion rates for each of the questionnaires (baseline; 1month follow up; 3month follow up)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Trial procedures and outcome measures: Sample size</measure>
      <time_frame>Baseline plus 3 months (84 days)</time_frame>
      <description>Sample size estimates for a future randomised control trial were assessed via changes in GHQ12 scores from baseline to 3month follow up.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability and usability: Usage</measure>
      <time_frame>Baseline plus 1 month (28 days), end of initial trial period</time_frame>
      <description>App usage data were collected from Google Analytics via Firebase (CA, USA) and included information such as the number of times the app was opened, the duration of each app use and the number of times specific sections of the app were used.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability and usability: MAUQ</measure>
      <time_frame>Baseline plus 1 month (28 days), end of initial trial period</time_frame>
      <description>The mHealth App Usability Questionnaire (MAUQ) was used to assess app usability at day 28. A 16 item version of the MAUQ of the self-report questionnaire was used, measured on a 7-point scale ranging from strongly disagree (1) to strongly agree (7). Participant responses were aggregated into overall usability and three other domains: ease of use and satisfaction, interface and functionality, and usefulness. The mean total score and the mean of each three domains were scored out of seven, with a score of four indicating a neutral response and higher scores indicating greater app usability.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">50</enrollment>
    <condition>Mental Health Issue</condition>
    <condition>Mental Health Wellness 1</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>The control group received an app containing only signposting information about a range of statutory and third sector organisations that focused on veterans' mental health.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The intervention group will receive a 'full' version of the app over the 1month trial period. The app consists of five core elements:&#xD;
  Personas developed as an aide to the provision of psycho-education on how mental health difficulties might look in real life and to help participants identify symptoms of mental health difficulties in themselves.&#xD;
  Daily life goals employing behavioural activation principles to encourage users to set a series of small tasks to help them achieve larger goals in different areas of their life e.g. work, family, physical health.&#xD;
  Self-help tools to provide participants with a range of resources that they can use independently to help them manage symptoms of mental ill-health they may be experiencing.&#xD;
  Tracking tools to allow users to monitor their own mental health and to see their progress across the elements of the app.&#xD;
  A schedule of daily notifications to encourage participants to continue to engage with the app.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>MeT4VeT mobile phone app: control</intervention_name>
      <description>The control/ sham comparator arm of the Mental Health Toolkit for Veterans (MeT4VeT) smart phone app contains only signposting information around support services available to military veterans</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>MeT4VeT mobile phone app: intervention</intervention_name>
      <description>The Mental Health Toolkit for Veterans (MeT4VeT) smart phone app has been developed through careful and close collaboration with military veterans and key providers of veterans' mental healthcare services. The aim of this app is to provide both a degree of education to support military veterans' understanding of mental health and foster self-recognition and management of mental health symptoms whilst also encouraging those who need it to seek more formal support.&#xD;
  The elements of the app have been chosen for inclusion as they represent the intersection between:&#xD;
  Core components of cognitive behavioural therapy, the theoretical framework underwriting the app&#xD;
  Behaviour change constructs</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Males&#xD;
  &#xD;
            -  Own a smartphone&#xD;
  &#xD;
            -  Served at least 2 years in the UK Armed Forces&#xD;
  &#xD;
            -  Left the UK Armed Forces within the last 2 years&#xD;
  &#xD;
            -  Not currently undertaking formal mental health treatment (mental health therapy by a&#xD;
               medical professional)&#xD;
  &#xD;
            -  Indicate a degree of mental health distress (assessed via a score of two or more on&#xD;
               the GHQ-12&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who display current suicidal ideation / self-harm&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Male</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nicola Fear, Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>King's College London</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sharon Stevelink, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>King's College London</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Neil Greenberg, Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>King's College London</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>King's College London</name>
        <address>
          <city>London</city>
          <zip>SE5 9RJ</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>MeT4VeT</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05993676
  org study id: 583696
  secondary id: DPRF-19/20-11079
  secondary id: 1074/MODREC/20
  nct id: NCT05993676
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The proposed research involves the running of a feasibility trial to assess a smart phone app
        designed to support military veterans (as they transition out of the Armed Forces)
        experiencing mental health difficulties to monitor and manage their mental health,
        encouraging them to seek formal mental healthcare services if required. The trial will
        compare participants who are provided with the 'full' app (case group) with participants who
        receive a 'signposting only' feature free smartphone app, receiving the 'full' app 3months
        later once the research trial is over (control group).
  
        The feasibility trial has two core aims:
  
          1. To provide initial assessment of the practicality of testing the app Running of the
             feasibility trial will provide key information on the practical delivery of the app and
             measurement processes; enable an estimation of recruitment and retention of
             participants; as well as trialling a series of outcome measures. All participants taking
             part in the trial will be asked to complete a short (20minute) in app survey at three
             time points: baseline; baseline plus 1month; baseline plus 3months. This questionnaire
             will collect demographic information and employ a number of well-being and quality of
             life measures.
  
          2. To provide initial feedback on the app The trial will qualitatively evaluate how those
             in the case group use the 'full' app (via collection of app usage data over a 1month
             trial period) and how easy to interact with, and potentially helpful, they consider the
             app might be (via a short 30minute telephone interview at the end of the 1month app
             trial period).
  
        If the trial indicates that the app is acceptable and feasible then a full randomized control
        trial (subject to funding) will be run to assess the effectiveness of the app in supporting
        mental health. If proven acceptable then the app would be made freely available to all.
  In line with the Medical Research Council Complex Intervention Framework (Medical Research
        Council) the feasibility stage of developing an intervention is focused on three areas to
        assess the practical aspects of testing an intervention including:
  
          -  Testing procedures (technical app delivery; measurement processes)
  
          -  Estimating recruitment and retention (number of eligible/ interested participants;
             drop-out rates)
  
          -  Determining sample size (testing main outcome measures to determine appropriate sample
             size for a later randomised control trial)
  
        In addition to this, the feasibility trial will provide feedback from participants on their
        reactions to the app including:
  
          -  Actual use of the app
  
          -  Satisfaction with the app
  
          -  How appropriate they believe the app to be
  
          -  Intent for continued use
  
        This toolkit will provide those who participate in the research with an additional support
        tool which may help them to manage their own mental health during a potentially challenging
        period (as they transition out of the Armed Forces) and help them to identify a need for more
        formal support if required.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Recruitment and retention: Number of interested participants
  time frame: 5month recruitment period
  description: Calculate the total number of participants contacting the study team to express an interest in taking part in the study.
  measure: Recruitment and retention: Number of eligible participants
  time frame: 5month recruitment period
  description: Calculate the total number of participants contacting the study team to express an interest in taking part in the study who are eligible to take part. Calculate this as a percentage of total number of interested participants.
  measure: Recruitment and retention: Response rate
  time frame: 5month recruitment period
  description: Calculate the total number of eligible participants who went onto complete the consent form. Calculate this as a percentage of total number of eligible participants.
  measure: Recruitment and retention: One month follow up retention rates
  time frame: Baseline plus 1 months (28 days), end of trial period
  description: Calculate the total number of participants enrolled onto the study who went onto complete the 1month follow up. Calculate this as a percentage of total number of enrolled participants.
  measure: Recruitment and retention 4: Three month follow up retention rates
  time frame: Baseline plus 3 months (84 days)
  description: Calculate the total number of participants enrolled onto the study who went onto complete the 3month follow up. Calculate this as a percentage of total number of enrolled participants.
  measure: Recruitment and retention 5: Comparability of sample to MOD personnel
  time frame: Baseline plus 3 months (84 days)
  description: Comparability of sample to Ministry of Defence statistics for major sub-groups of veterans (age, service branch, rank)
  measure: Trial procedures and outcome measures: Technical delivery
  time frame: Baseline plus 1 months (28 days), end of trial period
  description: Evaluation of the technical delivery of the app was gained through gathering feedback from developers and participants, identifying any potential technical issues
  measure: Trial procedures and outcome measures: GHQ12
  time frame: Baseline plus 3 months (84 days)
  description: The General Health Questionnaire (GHQ-12) is a measure of common mental disorders such as anxiety and depression. It is a 12-item self-report questionnaire measured on a 4-point scale. Scores range from 0-12 with a score of 4 or more indicative of probable mental ill health.The difference between scores at baseline, day 28 (1month) and day 84 (3months) were calculated.
  measure: Trial procedures and outcome measures: PCL-C
  time frame: Baseline plus 3 months (84 days)
  description: To evaluate symptoms of PTSD, the PTSD Checklist Civilian version (PCL-C) was used. It is a 17-item self-report questionnaire, measured on a 5-point scale from (1) not at all to (5) extremely. Scores range from 17 to 85, scores over 50 are indicative of possible PTSD. The difference between scores at baseline, day 28 (1month) and day 84 (3months) were calculated.
  measure: Trial procedures and outcome measures: Well-being
  time frame: Baseline plus 3 months (84 days)
  description: Warwick Edinburgh Mental Well-being Scale (WEMWBS) measures mental well-being within the previous two weeks and is a 14-item self-report questionnaire measured on a 5-point scale from (1) none of the time to (5) all of the time. Scores range from 14 to 70 with higher scores indicative of greater mental well being. The difference between scores at baseline, day 28 (1month) and day 84 (3months) were calculated.
  measure: Trial procedures and outcome measures: WHO QOL-BREF
  time frame: Baseline plus 3 months (84 days)
  description: Quality of life was assessed using the World Health Organization Quality of Life Assessment (WHOQOL-BREF), a 26-item self-report questionnaire divided into four domains: physical health; social relationships; psychological health; environmental health. It is measured on a 5-point scale, with a score of 0-100 calculated, where 100 equates to the best possible state of health. The difference between scores at baseline, day 28 (1month) and day 84 (3months) were calculated.
  measure: Trial procedures and outcome measures: Completion rates
  time frame: Baseline plus 3 months (84 days)
  description: Examination of the feasibility of using the app to collection outcome measures was assessed via completion rates for each of the questionnaires (baseline; 1month follow up; 3month follow up)
  measure: Trial procedures and outcome measures: Sample size
  time frame: Baseline plus 3 months (84 days)
  description: Sample size estimates for a future randomised control trial were assessed via changes in GHQ12 scores from baseline to 3month follow up.
  measure: Acceptability and usability: Usage
  time frame: Baseline plus 1 month (28 days), end of initial trial period
  description: App usage data were collected from Google Analytics via Firebase (CA, USA) and included information such as the number of times the app was opened, the duration of each app use and the number of times specific sections of the app were used.
  measure: Acceptability and usability: MAUQ
  time frame: Baseline plus 1 month (28 days), end of initial trial period
  description: The mHealth App Usability Questionnaire (MAUQ) was used to assess app usability at day 28. A 16 item version of the MAUQ of the self-report questionnaire was used, measured on a 7-point scale ranging from strongly disagree (1) to strongly agree (7). Participant responses were aggregated into overall usability and three other domains: ease of use and satisfaction, interface and functionality, and usefulness. The mean total score and the mean of each three domains were scored out of seven, with a score of four indicating a neutral response and higher scores indicating greater app usability.
  arm group label: Control
  arm group type: Sham Comparator
  description: The control group received an app containing only signposting information about a range of statutory and third sector organisations that focused on veterans' mental health.
  arm group label: Intervention
  arm group type: Active Comparator
  description: The intervention group will receive a 'full' version of the app over the 1month trial period. The app consists of five core elements:
  Personas developed as an aide to the provision of psycho-education on how mental health difficulties might look in real life and to help participants identify symptoms of mental health difficulties in themselves.
  Daily life goals employing behavioural activation principles to encourage users to set a series of small tasks to help them achieve larger goals in different areas of their life e.g. work, family, physical health.
  Self-help tools to provide participants with a range of resources that they can use independently to help them manage symptoms of mental ill-health they may be experiencing.
  Tracking tools to allow users to monitor their own mental health and to see their progress across the elements of the app.
  A schedule of daily notifications to encourage participants to continue to engage with the app.
  intervention type: Behavioral
  intervention name: MeT4VeT mobile phone app: control
  description: The control/ sham comparator arm of the Mental Health Toolkit for Veterans (MeT4VeT) smart phone app contains only signposting information around support services available to military veterans
  arm group label: Control
  intervention type: Behavioral
  intervention name: MeT4VeT mobile phone app: intervention
  description: The Mental Health Toolkit for Veterans (MeT4VeT) smart phone app has been developed through careful and close collaboration with military veterans and key providers of veterans' mental healthcare services. The aim of this app is to provide both a degree of education to support military veterans' understanding of mental health and foster self-recognition and management of mental health symptoms whilst also encouraging those who need it to seek more formal support.
  The elements of the app have been chosen for inclusion as they represent the intersection between:
  Core components of cognitive behavioural therapy, the theoretical framework underwriting the app
  Behaviour change constructs
  arm group label: Intervention
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Nicola Fear, Prof
  role: Principal Investigator
  affiliation: King's College London
  last name: Sharon Stevelink, PhD
  role: Principal Investigator
  affiliation: King's College London
  last name: Neil Greenberg, Prof
  role: Principal Investigator
  affiliation: King's College London
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  sharing ipd: No