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Stress, PsychologicalNCT03032952

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

A study testing "Feel Stress Free" mobile application in people with Stress, Psychological and Depression, run by University College, London.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stress, Psychological, Depression, Anxiety
What is being tested?
"Feel Stress Free" mobile application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
No sites listed yet
Study dates
Feb 2016to Oct 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

About this study

Official title: The Efficacy of a Mobile Application for Treating Depression and Anxiety Symptoms in University Students

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.

Read the 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.

Being tested
"Feel Stress Free" mobile application
Keywords
RCT, Computerised interventions, Mobile applications, Stress, Psychological, Depressive symptoms, Anxious symptoms, Students, Mental health
Medical subject headings
Stress, Psychological, Depression, Anxiety Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "Feel Stress Free" mobile applicationOther

    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 groups in NCT03032952
Study groupRoleWhat they receive
"Feel Stress Free"ExperimentalAccess 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.
Receives: Other: "Feel Stress Free" mobile application
Wait list controlNo interventionGiven access to the intervention at the end of the 12 weeks of the trial.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospital Anxiety and Depression Scale (HADS)

    A self-report measure comprised of 2 subscales, one for depression and one for anxiety.

    Measured: At baseline and then fortnightly for 12 weeks

Secondary outcomes (1)
  1. 1 Patient Health Questionnaire (PHQ-9)

    Self-report measure of depression used in UK primary care

    Measured: At baseline and then fortnightly for 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2017 (estimated)
  2. Study startFeb 2016
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03032952
Sponsor's protocol ID
8227/001
Status last verified
Jan 2017
First submitted
24 Jan 2017
Last updated
26 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 32735221

Questions about this trial

What is this clinical trial studying?

A study testing "Feel Stress Free" mobile application in people with Stress, Psychological and Depression, run by University College, London.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital Anxiety and Depression Scale (HADS) (time frame: At baseline and then fortnightly for 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03032952, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.

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