<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/NCT03032952</url>
  </required_header>
  <id_info>
    <org_study_id>8227/001</org_study_id>
    <nct_id>NCT03032952</nct_id>
  </id_info>
  <brief_title>The Efficacy of a Mobile Application for Treating Depression and Anxiety Symptoms</brief_title>
  <official_title>The Efficacy of a Mobile Application for Treating Depression and Anxiety Symptoms in University Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Roehampton</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a 12-week, parallel randomised controlled trial, including a 6-week follow-up. The&#xD;
      trial compared a group of university students (N = 84) receiving a mobile CBT application&#xD;
      intervention (&quot;Feel Stress Free&quot;) to a wait-list control group (N = 84) receiving no&#xD;
      intervention. Participants were asked to complete the Hospital Anxiety and Depression Scale&#xD;
      (HADS) and the Patient Health Questionnaire (PHQ-9) at baseline (as part of the screening&#xD;
      questionnaire) and then fortnightly for the 12 weeks. Although blinding was not possible&#xD;
      owing to the nature of a wait list control group, researchers did not have any face-to-face&#xD;
      contact with the participants, as recruitment and participation in the study was entirely&#xD;
      completed online.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project aimed to test the effectiveness of an application-based computerised Cognitive&#xD;
      Behavioural Therapy (cCBT) intervention named &quot;Feel Stress Free&quot; at reducing depression and&#xD;
      anxiety symptoms in a sample of UK university students.&#xD;
&#xD;
      This was a 12-week, parallel randomised controlled trial, comparing a group of university&#xD;
      students (N = 84) receiving the mobile intervention to a wait-list control group (N = 84)&#xD;
      receiving no intervention.&#xD;
&#xD;
      Recruitment took place within the four universities partnered with Thrive UK, all located in&#xD;
      London and the South East of England: University College London, University of Roehampton,&#xD;
      University of Buckingham and School of Oriental and African Studies (University of London).&#xD;
      Recruitment was via the student union or student welfare services of each university, using&#xD;
      email advertisements, poster advertisements, personal referrals from student welfare staff,&#xD;
      and social media (Twitter and Facebook). The study was conducted entirely online, with all&#xD;
      communication between trial personnel and participants via standardised emails.&#xD;
&#xD;
      Participants were instructed to sign up to the trial by navigating to a web page and&#xD;
      inserting their email address. They were then sent links to the participant information sheet&#xD;
      and consent form. Once they had given their consent, they were sent the screening&#xD;
      questionnaire. Randomisation occurred in blocks of 30 - each time 30 eligible participants&#xD;
      had completed the screening questionnaire, they were randomised by an independent&#xD;
      statistician, with an equal number of participants allocated to each arm.&#xD;
&#xD;
      Participants in the intervention group received a link to download the &quot;Feel Stress Free&quot;&#xD;
      application free of charge, and participants in the control group were informed that they&#xD;
      would receive access to the application when the trial was over. Those in the intervention&#xD;
      group were asked to use the app at least once per week for 15 minutes for the 6 weeks of the&#xD;
      main trial, and then as often as preferred for the follow-up period. The &quot;Feel Stress Free&quot;&#xD;
      application consists of relaxation activities such as breathing exercises, progressive muscle&#xD;
      relaxation and meditation, as well as relaxing mini-games, uplifting messages and negative&#xD;
      thought tracking. Users are prompted daily to measure and track their mood, and activity&#xD;
      recommendations are given if needed.&#xD;
&#xD;
      All participants were asked to complete the Hospital Anxiety and Depression Scale and Patient&#xD;
      Health Questionnaire fortnightly for the 12 weeks, with the screening questionnaire taken as&#xD;
      'week 0'. They were sent reminders throughout the week if they did not do so. The HADS is a&#xD;
      measure of the severity of anxiety and depression symptoms that an individual is&#xD;
      experiencing, and the PHQ is a measure of the severity of depression symptoms an individual&#xD;
      is experiencing. Both are suitable for use in the general population.&#xD;
&#xD;
      All questionnaires were completed via a secure email link, using Participant IDs assigned at&#xD;
      the beginning of the trial. All data were anonymised when stored, and each participant was&#xD;
      provided with a contact email address, which was used to seek help regarding the study or to&#xD;
      withdraw. Whilst it was not possible to blind trial personnel, owing to the nature of a wait&#xD;
      list control group, there was no face-to-face or personalised contact between trial personnel&#xD;
      and participants, unless a participant sent a query email.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2016</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>At baseline and then fortnightly for 12 weeks</time_frame>
    <description>A self-report measure comprised of 2 subscales, one for depression and one for anxiety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>1 Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>At baseline and then fortnightly for 12 weeks</time_frame>
    <description>Self-report measure of depression used in UK primary care</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">168</enrollment>
  <condition>Stress, Psychological</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>&quot;Feel Stress Free&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Access to the &quot;Feel Stress Free&quot; mobile application intervention for 12 weeks. Instructed to use it at least once per week for 15 minutes, for the first 6 weeks, then given free access thereafter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Given access to the intervention at the end of the 12 weeks of the trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>&quot;Feel Stress Free&quot; mobile application</intervention_name>
    <description>This online and mobile application uses relaxation techniques, thought challenging, mini-games and mood tracking to help reduce feelings of stress, anxiety and depression.</description>
    <arm_group_label>&quot;Feel Stress Free&quot;</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 or over&#xD;
&#xD;
          -  Provided informed consent&#xD;
&#xD;
          -  Self-identified as often feeling anxious or depressed, and scored 8 or above on one or&#xD;
             both subscales of the HADS (indicating at least possible caseness)&#xD;
&#xD;
          -  Currently a student at one of the four partnered universities&#xD;
&#xD;
          -  Had access to an Apple or Android phone or tablet, or a computer with Firefox, Safari&#xD;
             or Chrome installed&#xD;
&#xD;
          -  Able to use the aforementioned device (computer literacy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to provide a valid email address for one of the four partnered universities&#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>
  <overall_official>
    <last_name>Andres Fonseca, MBBS, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University College, London</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tayla L McCloud, MSc</last_name>
    <role>Study Director</role>
    <affiliation>University College, London</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elias Tsakanikos, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Roehampton</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RCT</keyword>
  <keyword>Computerised interventions</keyword>
  <keyword>Mobile applications</keyword>
  <keyword>Stress, Psychological</keyword>
  <keyword>Depressive symptoms</keyword>
  <keyword>Anxious symptoms</keyword>
  <keyword>Students</keyword>
  <keyword>Mental health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03032952
org study id: 8227/001
nct id: NCT03032952
lead sponsor: 
collaborator: 
has dmc: No
This was a 12-week, parallel randomised controlled trial, including a 6-week follow-up. The
      trial compared a group of university students (N = 84) receiving a mobile CBT application
      intervention ("Feel Stress Free") to a wait-list control group (N = 84) receiving no
      intervention. Participants were asked to complete the Hospital Anxiety and Depression Scale
      (HADS) and the Patient Health Questionnaire (PHQ-9) at baseline (as part of the screening
      questionnaire) and then fortnightly for the 12 weeks. Although blinding was not possible
      owing to the nature of a wait list control group, researchers did not have any face-to-face
      contact with the participants, as recruitment and participation in the study was entirely
      completed online.
This project aimed to test the effectiveness of an application-based computerised Cognitive
      Behavioural Therapy (cCBT) intervention named "Feel Stress Free" at reducing depression and
      anxiety symptoms in a sample of UK university students.

      This was a 12-week, parallel randomised controlled trial, comparing a group of university
      students (N = 84) receiving the mobile intervention to a wait-list control group (N = 84)
      receiving no intervention.

      Recruitment took place within the four universities partnered with Thrive UK, all located in
      London and the South East of England: University College London, University of Roehampton,
      University of Buckingham and School of Oriental and African Studies (University of London).
      Recruitment was via the student union or student welfare services of each university, using
      email advertisements, poster advertisements, personal referrals from student welfare staff,
      and social media (Twitter and Facebook). The study was conducted entirely online, with all
      communication between trial personnel and participants via standardised emails.

      Participants were instructed to sign up to the trial by navigating to a web page and
      inserting their email address. They were then sent links to the participant information sheet
      and consent form. Once they had given their consent, they were sent the screening
      questionnaire. Randomisation occurred in blocks of 30 - each time 30 eligible participants
      had completed the screening questionnaire, they were randomised by an independent
      statistician, with an equal number of participants allocated to each arm.

      Participants in the intervention group received a link to download the "Feel Stress Free"
      application free of charge, and participants in the control group were informed that they
      would receive access to the application when the trial was over. Those in the intervention
      group were asked to use the app at least once per week for 15 minutes for the 6 weeks of the
      main trial, and then as often as preferred for the follow-up period. The "Feel Stress Free"
      application consists of relaxation activities such as breathing exercises, progressive muscle
      relaxation and meditation, as well as relaxing mini-games, uplifting messages and negative
      thought tracking. Users are prompted daily to measure and track their mood, and activity
      recommendations are given if needed.

      All participants were asked to complete the Hospital Anxiety and Depression Scale and Patient
      Health Questionnaire fortnightly for the 12 weeks, with the screening questionnaire taken as
      'week 0'. They were sent reminders throughout the week if they did not do so. The HADS is a
      measure of the severity of anxiety and depression symptoms that an individual is
      experiencing, and the PHQ is a measure of the severity of depression symptoms an individual
      is experiencing. Both are suitable for use in the general population.

      All questionnaires were completed via a secure email link, using Participant IDs assigned at
      the beginning of the trial. All data were anonymised when stored, and each participant was
      provided with a contact email address, which was used to seek help regarding the study or to
      withdraw. Whilst it was not possible to blind trial personnel, owing to the nature of a wait
      list control group, there was no face-to-face or personalised contact between trial personnel
      and participants, unless a participant sent a query email.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: At baseline and then fortnightly for 12 weeks
description: A self-report measure comprised of 2 subscales, one for depression and one for anxiety.
measure: 1 Patient Health Questionnaire (PHQ-9)
time frame: At baseline and then fortnightly for 12 weeks
description: Self-report measure of depression used in UK primary care
arm group label: "Feel Stress Free"
arm group type: Experimental
description: Access to the "Feel Stress Free" mobile application intervention for 12 weeks. Instructed to use it at least once per week for 15 minutes, for the first 6 weeks, then given free access thereafter.
arm group label: Wait list control
arm group type: No Intervention
description: Given access to the intervention at the end of the 12 weeks of the trial.
intervention type: Other
intervention name: "Feel Stress Free" mobile application
description: This online and mobile application uses relaxation techniques, thought challenging, mini-games and mood tracking to help reduce feelings of stress, anxiety and depression.
arm group label: "Feel Stress Free"
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andres Fonseca, MBBS, MSc
role: Principal Investigator
affiliation: University College, London
last name: Tayla L McCloud, MSc
role: Study Director
affiliation: University College, London
last name: Elias Tsakanikos, PhD
role: Principal Investigator
affiliation: University of Roehampton
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Anxiety Disorders
mesh term: Stress, Psychological
sharing ipd: No