NCT03032952

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

January 24, 2017

Last Update Submit

January 24, 2017

Conditions

Stress, PsychologicalDepressionAnxiety

Keywords

RCTComputerised interventionsMobile applicationsStress, PsychologicalDepressive symptomsAnxious symptomsStudentsMental health

Outcome Measures

Primary Outcomes (1)

  • Hospital Anxiety and Depression Scale (HADS)

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

    At baseline and then fortnightly for 12 weeks

Secondary Outcomes (1)

  • 1 Patient Health Questionnaire (PHQ-9)

    At baseline and then fortnightly for 12 weeks

Study Arms (2)

"Feel Stress Free"

EXPERIMENTAL

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.

Other: "Feel Stress Free" mobile application

Wait list control

NO INTERVENTION

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

Interventions

"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.

"Feel Stress Free"

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32735221DERIVED

MeSH Terms

Conditions

Stress, PsychologicalDepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPersonal Satisfaction

Study Officials

  • Andres Fonseca, MBBS, MSc

    University College, London

    PRINCIPAL INVESTIGATOR

  • Tayla L McCloud, MSc

    University College, London

    STUDY DIRECTOR

  • Elias Tsakanikos, PhD

    University of Roehampton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2017

First Posted

January 26, 2017

Study Start

February 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

January 26, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share