search
Back to results

The Efficacy of a Mobile Application for Treating Depression and Anxiety Symptoms

Primary Purpose

Stress, Psychological, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
"Feel Stress Free" mobile application
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological focused on measuring RCT, Computerised interventions, Mobile applications, Stress, Psychological, Depressive symptoms, Anxious symptoms, Students, Mental health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 18 or over
  • Provided informed consent
  • Self-identified as often feeling anxious or depressed, and scored 8 or above on one or both subscales of the HADS (indicating at least possible caseness)
  • Currently a student at one of the four partnered universities
  • Had access to an Apple or Android phone or tablet, or a computer with Firefox, Safari or Chrome installed
  • Able to use the aforementioned device (computer literacy)

Exclusion Criteria:

  • Failure to provide a valid email address for one of the four partnered universities

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    "Feel Stress Free"

    Wait list control

    Arm 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.

    Given access to the intervention at the end of the 12 weeks of the trial.

    Outcomes

    Primary Outcome Measures

    Hospital Anxiety and Depression Scale (HADS)
    A self-report measure comprised of 2 subscales, one for depression and one for anxiety.

    Secondary Outcome Measures

    1 Patient Health Questionnaire (PHQ-9)
    Self-report measure of depression used in UK primary care

    Full Information

    First Posted
    January 24, 2017
    Last Updated
    January 24, 2017
    Sponsor
    University College, London
    Collaborators
    University of Roehampton
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03032952
    Brief Title
    The Efficacy of a Mobile Application for Treating Depression and Anxiety Symptoms
    Official Title
    The Efficacy of a Mobile Application for Treating Depression and Anxiety Symptoms in University Students
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2016 (undefined)
    Primary Completion Date
    October 2016 (Actual)
    Study Completion Date
    October 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University College, London
    Collaborators
    University of Roehampton

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress, Psychological, Depression, Anxiety
    Keywords
    RCT, Computerised interventions, Mobile applications, Stress, Psychological, Depressive symptoms, Anxious symptoms, Students, Mental health

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    168 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    "Feel Stress Free"
    Arm Type
    Experimental
    Arm 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 Title
    Wait list control
    Arm Type
    No Intervention
    Arm Description
    Given access to the intervention at the end of the 12 weeks of the trial.
    Intervention Type
    Other
    Intervention Name(s)
    "Feel Stress Free" mobile application
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Hospital Anxiety and Depression Scale (HADS)
    Description
    A self-report measure comprised of 2 subscales, one for depression and one for anxiety.
    Time Frame
    At baseline and then fortnightly for 12 weeks
    Secondary Outcome Measure Information:
    Title
    1 Patient Health Questionnaire (PHQ-9)
    Description
    Self-report measure of depression used in UK primary care
    Time Frame
    At baseline and then fortnightly for 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Aged 18 or over Provided informed consent Self-identified as often feeling anxious or depressed, and scored 8 or above on one or both subscales of the HADS (indicating at least possible caseness) Currently a student at one of the four partnered universities Had access to an Apple or Android phone or tablet, or a computer with Firefox, Safari or Chrome installed Able to use the aforementioned device (computer literacy) Exclusion Criteria: Failure to provide a valid email address for one of the four partnered universities
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andres Fonseca, MBBS, MSc
    Organizational Affiliation
    University College, London
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Tayla L McCloud, MSc
    Organizational Affiliation
    University College, London
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Elias Tsakanikos, PhD
    Organizational Affiliation
    University of Roehampton
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32735221
    Citation
    McCloud T, Jones R, Lewis G, Bell V, Tsakanikos E. Effectiveness of a Mobile App Intervention for Anxiety and Depression Symptoms in University Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 31;8(7):e15418. doi: 10.2196/15418.
    Results Reference
    derived

    Learn more about this trial

    The Efficacy of a Mobile Application for Treating Depression and Anxiety Symptoms

    We'll reach out to this number within 24 hrs