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
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
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
NCT ID
NCT03032952
First Posted
January 24, 2017
Last Updated
January 24, 2017
Sponsor
University College, London
Collaborators
University of Roehampton
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
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