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

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ClinicalTrials.gov Identifier: NCT03032952
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Collaborator:
University of Roehampton
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date  ICMJE January 24, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date January 26, 2017
Study Start Date  ICMJE February 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
Hospital Anxiety and Depression Scale (HADS) [ Time Frame: At baseline and then fortnightly for 12 weeks ]
A self-report measure comprised of 2 subscales, one for depression and one for anxiety.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
1 Patient Health Questionnaire (PHQ-9) [ Time Frame: At baseline and then fortnightly for 12 weeks ]
Self-report measure of depression used in UK primary care
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of a Mobile Application for Treating Depression and Anxiety Symptoms
Official Title  ICMJE The Efficacy of a Mobile Application for Treating Depression and Anxiety Symptoms in University Students
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stress, Psychological
  • Depression
  • Anxiety
Intervention  ICMJE Other: "Feel Stress Free" mobile application
This online and mobile application uses relaxation techniques, thought challenging, mini-games and mood tracking to help reduce feelings of stress, anxiety and depression.
Study Arms  ICMJE
  • Experimental: "Feel Stress Free"
    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.
    Intervention: Other: "Feel Stress Free" mobile application
  • No Intervention: Wait list control
    Given access to the intervention at the end of the 12 weeks of the trial.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2017)
168
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03032952
Other Study ID Numbers  ICMJE 8227/001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University College, London
Study Sponsor  ICMJE University College, London
Collaborators  ICMJE University of Roehampton
Investigators  ICMJE
Principal Investigator: Andres Fonseca, MBBS, MSc University College, London
Study Director: Tayla L McCloud, MSc University College, London
Principal Investigator: Elias Tsakanikos, PhD University of Roehampton
PRS Account University College, London
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP